PAAB Q&A

Question 1

Wed, 22 Oct 2025 21:04:23 GMT

If a fax were to be sent to physicians stating only the study name (I.e. ABC), what disease area it was studying (i.e. CHD mortality) and the major results (i.e. decreased mortality) but there was no drug mention; but provided a website for the study and a 1-800 number for further information, would this require approval? What if name of the study included both drugs that were compared (i.e. Alefacept Benzoperoxide Comparison)?

Question 2

Wed, 22 Oct 2025 21:04:20 GMT

We are getting a new indication that was based solely on a very small open-label study with a subjective endpoint. The study was not mentioned at all in the PM, however, it was published.

Question 3

Wed, 22 Oct 2025 21:04:18 GMT

If there are more than two studies that show the same outcome (e.g.: Improved BP reduction Vs a competing ARB) then do we still ask for disclosure of study parameters? Code s5.11 says this should not be required.

Question 4

Wed, 22 Oct 2025 21:04:16 GMT

Why can't information from a study be used if the reference appears in the bibliography section of the Product Monograph?

Question 5

Wed, 22 Oct 2025 21:04:14 GMT

Does a poster (developed by Canadian pharma company) intended to be used at an international conference need PAAB approval?

Question 6

Wed, 22 Oct 2025 21:04:12 GMT

Do patient education tools that are distributed by physicians and endorsed and approved by a national medical society or organization of specialists need be approved by PAAB?

Question 8

Wed, 22 Oct 2025 21:04:10 GMT

I was curious, to your knowledge , how many companies are currently operating within the PAAB meeting report exemption , either legitimately or otherwise . I know if anybody has this information it would be likely yourself. I am curious and was hoping you could shed some light on this issue

Question 9

Wed, 22 Oct 2025 21:04:08 GMT

If we put a BRC regarding a patient program regarding our product in the product package, do we have to send the patient program for PAAB review?

Question 10

Wed, 22 Oct 2025 21:04:06 GMT

What does "well-controlled and/or well-designed" in s. 3.1.1 mean?

Question 12

Wed, 22 Oct 2025 21:04:04 GMT

ACME Pharma ha 20% of the share in Rx's in its class and has been gained about 5% share over the previous year. NEWGUY Pharma has a 2% share, up from 1% the previous year. Can NEWGUY claim "fastest-growing" product within its class by virtue of a 100% growth? Even though ACME experienced only a 20%, twenty percent of a million is a lot more 100% of 20,000. How would PAAB rule NEWGUY's claim of "fastest-growing" or "largest annual growth"?

Question 14

Wed, 22 Oct 2025 21:04:02 GMT

Could a brand name be placed on a plastic portfolio that would contain a reprint carrier.

Question 15

Wed, 22 Oct 2025 21:03:59 GMT

Are there specific APS guidelines for corporate booth panels? Is it possible to create a panel/poster that just lists the product and its indication and not provide full product balance (i.e. adverse events and contraindications)? Full product balance/PI would be available at the same corporate booth.

Question 16

Wed, 22 Oct 2025 21:03:57 GMT

Can a pharmaceutical company distribute a third party piece (a textbook) via their representatives? It is a textbook that they are providing sponsorship for only and thus is exempt from PAAB rules. Does this book require a reference section with the product monograph in it as the product is discussed within the content of the textbook?

Question 17

Wed, 22 Oct 2025 21:03:55 GMT

If a reprint carrier is being produced, can the content be based on the paper even if some of the points to be made are not part of the product monograph? For example, if data pertaining to subgroup and multivariate analyses were not included in the product monograph but are discussed in the article, can they, i.e., subgroup and multivariate analysis, be part of the text highlighted on the reprint carrier?

Question 18

Wed, 22 Oct 2025 21:03:53 GMT

When new data is published outside of the Product Monograph, can this data be used for promotional pieces?

Question 19

Wed, 22 Oct 2025 21:03:51 GMT

Do Contrast Media and Nuclear Medicine products fall under the PAAB code?

Question 22

Wed, 22 Oct 2025 21:03:49 GMT

A pharma company has commissioned a third-party to create a patient support package. This package is given free to the patient from the doctor when they begin treatment. The package contains product monograph and consumer products to help with the drug's side-effect management. Can the package also contain products that do not deal with the side effect management, but relate to the product's target age group ie: a purse or wallet, a backpack, free music downloads etc? And is there a limit on the value allowed for the patient support package?

Question 23

Wed, 22 Oct 2025 21:03:47 GMT

How do you know when to submit an APS as a Detail Aid APS (s. 6.3) or a Service-Oriented Vehicle (s. 6.4)? Are there characteristic hallmarks that tell you which way one should go?

Question 24

Wed, 22 Oct 2025 21:03:45 GMT

The PAAB Code defines single sponsor publications in section 11.9, and notes in section 6.1 that branded content inserted into same are Journal Advertisement APS. Is the balance of the content of a single-sponsor publication exempt from PAAB review? Or is it considered service-oriented or detail aid APS? What if the ad is placed in a publication for the purpose of sponsorship of an ongoing title offered by an Independent Publisher?

Question 26

Wed, 22 Oct 2025 21:03:43 GMT

In section 6.1 of the PAAB Code is the following: Journal advertisements are designed to promote an advertiser's products to health professionals via the media of single [11.9] or multi-sponsored publications. Section 11.9 clarifies that: For purposes of this Code, Private/Single Sponsor Journals, newsletters and other publications are defined as any commissioned communication prepared or controlled by the manufacturer or its agent. When can a publication be considered a journal? I ask because I am interested in supporting a single-sponsor publication by placement of an ad, but am uncertain whether this publication is actually a journal or a service-oriented vehicle. Can I place a journal ad in a service-oriented vehicle?

Question 27

Wed, 22 Oct 2025 21:03:41 GMT

We recently made a complaint to PAAB about a detail aid which our competitor is using, as the detail aid is not PAAB-approved. We have heard nothing in response, and are wondering what we can expect from the process.

Question 28

Wed, 22 Oct 2025 21:03:39 GMT

I would like to run a print DTC advertizing campaign. The content will be limited to the brand name and a sentence along the line of 'ask your doctor'. No claims will be made. The media used is not targeting any specific audience. I would like to know: if the text has to be submitted if the text on the actual support has to be submitted which articles of the code I should refer to

Question 29

Wed, 22 Oct 2025 21:03:37 GMT

If a non-profit organization is producing patient support materials funded by an unrestricted grant from a pharmaceutical company (who is completely hands off and has no involvement other than funding), are these materials PAAB-exempt? The materials will be reviewed by a panel of health care practitioners to ensure validity and relevance of the information.

Question 30

Wed, 22 Oct 2025 21:03:35 GMT

Can risk data be presented for patients with concomitant risk factors. ie, the product is a statin that is indicated to reduce cholesterol and also CV events in patients with high cholesterol. The registration trial obviously included patients with high cholesterol and other risk factors. Can risk data be presented on patients with hypercholesterolemia and a risk factor within the registration trial?

Question 31

Wed, 22 Oct 2025 21:03:33 GMT

Where can I find good samples of detail aid online?

Question 33

Wed, 22 Oct 2025 21:03:31 GMT

Once a journal ad is PAAB approved, are we required to resubmit the approved JA for PAAB approval if the only change that will be made is to the dimension of the JA (eg, from standard to tabloid size)?

Question 34

Wed, 22 Oct 2025 21:03:29 GMT

Heatlh Canada has issued a policy entitled "Distinction Between Advertising and Other Activities" which states that " No one factor in itself will determine whether or not a particular message is advertising. Each message must be evaluated on its own merit and other factors may apply." An earlier response in this forum suggested that if it was a single sponsored publication, it was quite likely to be advertising if it dealt with therapeutics (you used the term "rarely" to describe the incidence with which you have seen non-promotional single-sponsored 3rd Party pieces.) Here's my question - if it is a single sponsored publication and mentions both the sponsor's and the competitor's products, giving them more coverage than "name, price, quantity", but not creating an impression in the reader's mind of bias, is it advertising? It seems obvious that one person's perception of information distribution "...serves to promote the sale of that product either directly or indirectly" (s11.1) may differ from anothers. And how does pharma or their agents know when when the line from "other activity" to "advertising", based on Health Canada's policy, has been crossed, short of a violation or submitting everything for a review?

Question 35

Wed, 22 Oct 2025 21:03:27 GMT

At a recent visit to my physician, I ran across a display of disease information brochures (eg, diabetes) branded with a product name in the waiting room. I was always under the impression that this would be considered DTC and that we are not allowed to provide branded disease information to the general public. Can you clarify?

Question 36

Wed, 22 Oct 2025 21:03:25 GMT

In your answer to question 34, you state "If the information is created independently of the company it is usually not advertising." I can think of clear examples of "text or reference books" that are produced by an independent publisher, but which deal almost exclusively with a single pharmaceutical product. If such items are paid for and distributed by company representatives, even though produced independently, are they advertising?

Question 38

Wed, 22 Oct 2025 21:03:23 GMT

Regarding Representative distribution of CME Accredited Materials: Can a program supporter have their representatives distribute or base discussions on CME accredited materials ? If I look at the these points it is unclear to me if indeed there can be representative involvement if so, at what level? :1.5(2) Materials that are created by the academic organizers of accredited Continuing Education events/activities may be distributed at the event or to the registrants of that meeting at a later date. 1.5(3) If materials are to be distributed after the event to non-participants of the event by a sponsor company, and product or therapeutic claims, comparative data or statements regarding the sponsors products are included, the complete document must be submitted to the PAAB for review. The respective roles of the authors and the sponsoring pharmaceutical company must be stated clearly on the title page.

Question 39

Wed, 22 Oct 2025 21:03:21 GMT

Are we required to send material on disease awareness to the PAAB, even if there is no product metnion? Is there a distinction if it is leave behind vs. non-leave behind (eg, a detail piece on hypertension and the MOA of how a therapetuic class works)?

Question 40

Wed, 22 Oct 2025 21:03:19 GMT

At a recent medical conference there was a company display that promoted a disease specific message. There was no product mention and the posters did not go to PAAB, although the imformation clearly introduces a specific message. As per question and answer #39, this would seem to be within guidelines, assuming there was no other promotional material at the booth. The complicating factor is that this company does not have an approved product for the disease state being presented. There is a great deal of discussion and "noise" surrounding their product and when it will be available but, to date, it has not receieved NoC. Is this within guidelines? It appears to be promotion for a product currently undergoing review?

Question 41

Wed, 22 Oct 2025 21:03:17 GMT

Just looking for some clarification on PAAB review of health education material (CME accredited, third party accrediated workshops, etc.). When sent in for review, will PAAB be providing an opinion only, or would it be acceptance of the material under review? Additionally, will existing printed material need to be sent to PAAB for review, or is just newly created material that has this requirement of review? Thanks in advance for the help in answering.

Question 42

Wed, 22 Oct 2025 21:03:15 GMT

Please outline the rules for the following: If a client wishes to use a product reminder ad without any accompanying prescribing information (assuming that there are no claims and the product is a minimum 2 years old with no reports of new adverse reactions)

Question 43

Wed, 22 Oct 2025 21:03:13 GMT

I am interested in producing an empty folder with my product name and logo on the front, PI on the back. The folder is to be provided to representatives with no contents. Reps would have a choice of any currently valid and PAAB approved contents to place inside, the whole package to be left with the physician. When I submit the folder to the PAAB for review, is it sufficient to explain that the only possible contents will be valid and PAAB approved APS, or is it necessary that I submit with all the possible combinations and permutations of contents? Am I permitted to submit for review a reprint which I would also like to be available for inclusion?

Question 44

Wed, 22 Oct 2025 21:03:11 GMT

I support a number of small products which are supported by one sales force. In order to simplify detailing efforts, I would like to produce one detail aid for all the products, with a few pages dedicated to each one. When it comes to the prescribing summaries, should these be placed together at the end of the detail aid, or with the pages related to that product?

Question 45

Wed, 22 Oct 2025 21:03:09 GMT

Can peer reviewed journal article reprints be distributed by sales reps or sent by direct mail if they contain off-label discussion of a drug? What about textbooks purchased from a publisher (no development involvement by the pharma company)?

Question 46

Wed, 22 Oct 2025 21:03:07 GMT

As a follow up to Question 45, if the off-label content of a peer reviewed journal article is not the focus and will not be discussed by the rep, can a disclaimer be added indicating that the product should not be used off-label, any off-label content is not applicable in Canada and to refer to appropriate product monographs?

Question 47

Wed, 22 Oct 2025 21:03:05 GMT

If we offer samples to physicians, by a 3rd party company, do we need to get PAAB approval of the offer/promotion if it only contains an graphic/image of the brand name, logo, and quantity of samples offered. There will be no claims made...only this minimal information. Does a PI need to accompany the offer?

Question 48

Wed, 22 Oct 2025 21:03:03 GMT

I have already submitted a product's website copy for PAAB approval; however I was hoping to receive clarification around the requirements for submitting the website layout to PAAB: Is it sufficient to send the design for a few of the different pages within the site, or would you prefer we submit all pages included within the site? Should we be submitting the design once the copy has been PAAB-approved, or can we submit simultaneously? Does PAAB like to review the actual website before launch? If you could provide a few details around website layout submission, it would be greatly appreciated. I've referred to explanatory note 6.5.11 for guidance.

Question 49

Wed, 22 Oct 2025 21:03:01 GMT

Can a product manager or medical manager provide a slide set to a customer upon request if the slide set contains off-label information?

Question 50

Wed, 22 Oct 2025 21:02:59 GMT

To restrict access to patient web site we usually use the DIN as an accepted method of verifying that the visitor is indeed a patient before granting access. But we are currently working on a web site for a drug where the patients never receive the product packaging. Some of them might be able to find the DIN on their drug store receipt but some receipts don't have that information. Are there other accepted methods of restricting access to a patient web site in case the DIN is not available?

Question 53

Wed, 22 Oct 2025 21:02:57 GMT

Are vaccines treated the same way as prescription drugs for advertising purposes? For DTC, can the brand name of a vaccine be mentioned?

Question 54

Wed, 22 Oct 2025 21:02:55 GMT

Can we create a program that is directed towards patients as the recipients? Is this considered advertising (direct-to-consumer)? Would it require PAAB review? The content within the program would be on-label.

Question 56

Wed, 22 Oct 2025 21:02:53 GMT

Question 57

Wed, 22 Oct 2025 21:02:51 GMT

How do you approach companies to support your organization?

Question 58

Wed, 22 Oct 2025 21:02:49 GMT

For an advertisement stating that sample packages for Product X are available from company Y's pharmaceutical sales representatives, would PAAB preclearance review be required?

Question 59

Wed, 22 Oct 2025 21:02:47 GMT

Is Brogan data an acceptable data source to show how long your patients are staying on therapy?

Question 60

Wed, 22 Oct 2025 21:02:45 GMT

Can you please provide some clarity on the criteria regarding co-sponsorship with a physician/patient/nurse/pharmacist group(s) that would allow for PAAB exemption? That is, what criteria make one group more or less acceptable from a PAAB perspective? To clarify, if a pharma company wishes to sponsor the development of and work with an organization to supply patients with information on a particular disease state/condition in an unbranded piece how does PAAB judge whether this would/would not be exempt from pre-clearance.

Question 61

Wed, 22 Oct 2025 21:02:43 GMT

If an APS makes a usage claim (number of prescriptions or patient-years, for example) for an agent and shows the product logo, but provides no therapeutic claims for the product, does the indication have to be included? Other than an acceptable reference for the usage claim, is there any other balance copy necessary?

Question 62

Wed, 22 Oct 2025 21:02:41 GMT

Revised October 2019: Is PAAB concerned if we are correcting typos, punctuation and spelling from a Product Monograph as it enters into a formatted monograph? Some monographs contains such errors yet pass through Health Canada approval. Does PAAB or Health Canada have a concern if these errors are corrected as the product enters promotion?

Question 63

Wed, 22 Oct 2025 21:02:39 GMT

When Pharma company sites post their PIs, or Rx drug ads on web sites link back to their PIs - does the access to the PI have to be password protected?

Question 64

Wed, 22 Oct 2025 21:02:36 GMT

Does exhibit booth panel text generated by head offices outside of Canada require PAAB approval for International conferences and symposia held in Canada? Does an entry in an Exhibit Guide for an International conference or symposium generated by head offices outside of Canada summarizing a recent peer reviewed published clinical trial require PAAB approval?

Question 65

Wed, 22 Oct 2025 21:02:34 GMT

Is it necessary to include "Product Monograph available on request" on a direct mail or leave-behind that advises doctors of a drug now being covered on provincial formulary for a specific indication? No claims other than "Brand X now covered on Formulary y for z" (will have the exact wording from the provincial formulary). Understand that fair balance copy needs to be included and this will be submitted to PAAB.

Question 66

Wed, 22 Oct 2025 21:02:32 GMT

Does the exemption section 6.6d apply to new formats as well? As an example, "Company X is pleased to announce the availablity of a new format y for Product Z. For more information please contact...."

Question 67

Wed, 22 Oct 2025 21:02:30 GMT

If a product has a universally-accepted trait (such as no dose adjustment, no specific drug interaction), but this is not stated specifically in the TMA, can this claim be stated? At times, some things are not specifically stated in the TMA or the TMA is not updated for a period of time. If a trait is universally-accepted, should it not be permitted to make this claim?

Question 68

Wed, 22 Oct 2025 21:02:28 GMT

What is the Canadian specific definition for "off label" regarding reprints? FDA in it's draft guidance Good Reprint Pratices refer to indications and treatment regimens. PAAB code section 3.2 indicates material "must be consistent" with the indications, dosage regimens, efficacy and safety information information in the Cdn TMA. If the article is not specifically listed in the TMA, does it automatically be become "off label"?

Question 69

Wed, 22 Oct 2025 21:02:26 GMT

The CFPC has reviewed and approved a program for Mainpro-M1 credits and is awaiting final accreditation by the College's provincial chapter. Are materials used within the program (e.g. Slide Kit) exempt from PAAB review in the following cases: • Case 1 - Distributed to participants at the accredited event or at a later date? • Case 2 - Distributed to non-participants by sales reps?

Question 70

Wed, 22 Oct 2025 21:02:24 GMT

The PAAB codes allows side by side comparison of non-clinical data from 2 or monographs. Would it be acceptable to use a comparative table of non-clinical data (ie. pharmacokinetics) from a review article? Extract from 5.10.2: [Information from two or more Product Monographs on products' properties7 and on instructions for use or use limitations8 may be acceptable as side-by-side presentations and in text form.]

Question 71

Wed, 22 Oct 2025 21:02:23 GMT

As per 6.6d and the exemption of "now on provincial formulary", does this apply to a change in formulary status? As an example "Product Y has a new formulary status". This is of course would not be linked to a therapeutic message but is intended to inform the audience of a change in formulary status. Would such a mention be PAAB exempt?

Question 72

Wed, 22 Oct 2025 21:02:21 GMT

In order for a prescription to be filled for product X, the doctor must submit a form which will function as the prescription to a 3rd party distributor. the form also includes the patient's signature which allows the patient to request the 3rd party company to research the patient's insurance coverage for product x on their behalf. There are no product claims on the form (no efficacy, no safety, nothing). Only the doctor receives the form (the patient can not get it any other way then when the doctor makes the decision to Rx the drug for the patient). The drug is restricted to a very specific indication; therefore the form includes the specific diagnosis code to allow the 3rd party to ensure that the drug is no prescribed off label. The form is a strictly administrative document, the pharma company never has access to any of the specific information (no doctor names, no patient names etc...). Am I correct in my conclusion that this would not need PAAB review?

Question 73

Wed, 22 Oct 2025 21:02:19 GMT

What is the policy and scope of a PAAB review for Canadian-based websites by manufacturers to support their prescription drug products? Is there a required/preferred review cycle - such as one a year? How does PAAB assess information on the website that is outside of the Product Monograph per se (i.e. - information on the disease state, practical tips for patients managing/coping with their disease apart from drug therapy, links to other websites like a medical association's guidelines)?

Question 74

Wed, 22 Oct 2025 21:02:17 GMT

When a new company purchases an existing brand with existing PAAB approved marketing materials, do we need to resubmit those materials if the only changes relate to corporate ownership and the replacement PI?

Question 75

Wed, 22 Oct 2025 21:02:15 GMT

I am wondering if PAAB rules allow pharmaceutical companies to run a contest for a consumer product of low value on a gated professional website? Eg. run an online ad asking doctor's to submit their own tagline for an ad and win a basket with $50 worth of products in it? If you need more detail, please give me a call.

Question 76

Wed, 22 Oct 2025 21:02:12 GMT

Can you please clarify if there are any differences in terms of the PAAB review of an NOC/c product vs a product with full NOC?

Question 77

Wed, 22 Oct 2025 21:02:10 GMT

Can we use American guidelines to complement or supplement Canadian guidelines in promotional pieces? Often guidelines may have slightly different recommendations or one maybe published later than the other.

Question 78

Wed, 22 Oct 2025 21:02:08 GMT

Further to the question #76, could you distinguish what 'special conditions' refers to? Also, can the key clinical trial be used as support for NOCC advertising, even if it does not appear in the PM in its entirety?

Question 79

Wed, 22 Oct 2025 21:02:06 GMT

Could you please provide some clarity around the definition on Formulary Kits as described in "The Distinction Between Advertising and Other Activities". Specifically, is it appropriate for a company's sales representative to distribute formulary kits to formulary committees in a hospital setting?

Question 80

Wed, 22 Oct 2025 21:02:04 GMT

I recently received a copy of your December newsletter which refers to changes that will be taking place on April 2009. With respect to 2.4.3, would you consider a non-prescription, schedule D vaccine to fall into this category? And what about a Schedule F drug, that is non-prescription in Ontario?

Question 81

Wed, 22 Oct 2025 21:02:02 GMT

Mon client doit faire une pièce visuelle descriptive de son produit qui sera remise aux professionnels qui l'utilisent, soit les médecins et les technologues. Le produit se nomme SmartVent et c'est un système de délivrance radioaérosol qui permet la production d'imagerie de ventilation pulmonaire. Je ne suis pas certaine si cette publicité doit être envoyée à PAAB pour approbation car c'est un 'medical device'. J'aimerais être certaine des règlements pour ce genre de produit.

Question 82

Wed, 22 Oct 2025 21:02:00 GMT

We are currently preparing our submission for a new product to Health Canada. In the meantime, the company is preparing it's financial report for the investors and they would like to include a section on the disease, it's implication on patients and a section on the molecule itself with results of it's phase III trials. Are there any restrictions, and/or do we have to submit the report to PAAB?

Question 83

Wed, 22 Oct 2025 21:01:58 GMT

Once PAAB approves a patient information brochure, does it ever expire? In other words, can we reprint a brochure that was previously PAAB approved and distributed several years ago? Also, what if the product has a change in ownership - if the brochure was previously approved by the seller of the product, can the buyer of the product use the same content without re-submitting for a new approval? The only change would be the addition of the new owners trademarks and the removal of the previous owners trademarks.

Question 84

Wed, 22 Oct 2025 21:01:56 GMT

Recently the FDA issued new guidance for the distribution of medical journal articles and medical or scientific reference publications by drugmakers that address off-label uses of approved compounds. Among the new recommendations, the FDA stated that the drug manufacturers will no longer have to submit medical journal articles on unapproved new uses of cleared products to the FDA before distributing the studies to physicians. What influence will this have on HEalth Canada policy and what influence will this have on PAAB's rules around distribution of these types of articles by drugmakers representatives.

Question 85

Wed, 22 Oct 2025 21:01:54 GMT

Could you please confirm for me whether or not a Dear Doctor letter outlining a Nursing Assessment program needs PAAB approval. The program is being run by a 3rd-party. The letter does not contain any information about product and it outlines the parameters of the program itself (i.e. # of patients needed to be recruited, length of day, etc.) The Dear Doctor letter is being left with the doctor and it is being delivered and signed by the representative.

Question 86

Wed, 22 Oct 2025 21:01:52 GMT

Could you give me any clue about the adversting or marketing expenses limit set by the government for a pharmaceutical company in a year?

Question 87

Wed, 22 Oct 2025 21:01:50 GMT

We are producing a directory of canadian clinics that offer a specific test. There will be an introduction outlining why the test is important, how it is done etc. The booklet will be sponsored by a drug company (corporate logos will be on the cover) but there is nothing in it that mentions their or any other company's drug products (and they have no affiliation with the tests, clinics or instruments used). The booklet will be distributed by the sponsors reps as a service. Healthcare providers will offer independent review of the content. Does this require PAAB review?

Question 88

Wed, 22 Oct 2025 21:01:48 GMT

I understand that if a company decides to hand out the full PM instead of a PI, it is fine. My question is: Would a verbatim copy of part 1 and 3 of the PM (Health Professional Info and Consumer Info) also meet that requirement (i.e. the full PM but omitting Part 2).

Question 89

Wed, 22 Oct 2025 21:01:46 GMT

Would a live event whereby healthcare professionals are invited to hear key opinion leaders discuss unmet need in a therapeutic area and a drug that has just obtained NOC be deemed subject to preapproval by PAAB? The live events would be sponsored by the pharma company whose drug has just obtained NOC. The purpose would be to inform prescribers of the approved indications and appropriate clinical usage. The program would not be accredited.

Question 90

Wed, 22 Oct 2025 21:01:44 GMT

Does PAAB follow the US Pharma codes requirement that companies can not provide giveaways at promotional conventions as of 2009. However, for a US company that is participating in a canadian international convention that is currently licensed in the US for a particular product or use but not licensed in Canada, are giveaways at the booth appropriate, and if so what kind of giveaways are appropriate?

Question 91

Wed, 22 Oct 2025 21:01:42 GMT

Can sales representatives distribute educational materials that have been commissioned by their pharma company. The content of the educational material is produced by an independant expert faculty in a given disease area and content is reviewed by an University for balance & scientific integrity and endorsed as being deemed appropriate for Mainpro 2 or Section 2 credits. For reps to be able to distribute the information do the materials need to be reviewed by PAAB even though they are not promotional but rather educational?

Question 92

Wed, 22 Oct 2025 21:01:40 GMT

I have a question regarding minimum font size for safety and balancing copy. It is clear in the PAAB code that it is required to be 75% of the main claim in size. The reasons for this are obvious if one is producing a journal ad or printed piece - the balance copy must be legible. However, if the APS is a 10 foot high panel, does the same ratio apply? In such a case, the balancing copy is almost beyond legible (too big) and consumes the entire bottom of the panel.

Question 93

Wed, 22 Oct 2025 21:01:38 GMT

As follow-up to question 91 and as referenced in question and answer 46, if the off-label content of the educational material (publication) is not the focus and will not be discussed by the rep, and that the reps are trained to use the material in a non-promotional manner, would this then comply to PAAB exemption?

Question 94

Wed, 22 Oct 2025 21:01:36 GMT

Would a card describing the Ontario Drug Reimbursement process (codes, who to contact, etc) for a drug be PAAB exempt? Example - Title might say "Reimbursement of [drug class] including drugX". Drug logo (no tagline) included.

Question 95

Wed, 22 Oct 2025 21:01:34 GMT

Pourquoi ce site web: http://cavabiencavamal.ca/index_fr.html n'a pas l'approbation du PAAB. Est-ce que les sites web ne comptent pas comme un médias? De plus, il n'y a pas la mention de qui sponsor le site,ce ne serait-il pas contraire à l'article 6.5.2?

Question 96

Wed, 22 Oct 2025 21:01:32 GMT

Is it possible to include any brand/company logo to media materials such as a press release or fact sheet?

Question 97

Wed, 22 Oct 2025 21:01:30 GMT

Is there a current practice to use a symbol "PR" to designate a prescription drug, like in trade-marks where the symbols "TM" or (R) are used ? And if so, what are the rules of use for such symbol?

Question 98

Wed, 22 Oct 2025 21:01:28 GMT

Do you have an example of how to write an APS?

Question 99

Wed, 22 Oct 2025 21:01:26 GMT

Does PAAB have specific rules regarding Pre-NOC communications

Question 100

Wed, 22 Oct 2025 21:01:24 GMT

Are all promotional materials for health care professionals for natural health products required to have PAAB approval? or is this a voluntary action?

Question 101

Wed, 22 Oct 2025 21:01:22 GMT

Can you please clarify the relationship between the placement of balancing information and a product logo? It is unclear as to why the product logo must signify the 'end' of the main advertising message.

Question 102

Wed, 22 Oct 2025 21:01:20 GMT

Can a pharmaceutical company provide ,upon request from a Third party HCP controlled website, a company produced educational slide deck ( disease and treatment) that has not been reviewed and approved by PAAB.The third party website wishes to provide these educational slide kits to their members as self learning resources.

Question 103

Wed, 22 Oct 2025 21:01:18 GMT

If we have a non-branded poster, talking about a disease and with a call to action: talk to your doctor. This poster will be given to the secretary of the doctor's office by the pharmaceutical representative and then will be posted in the examining room. Is this subject to PAAB review? Also with the poster there will be a booklet disease oriented for patients also to be given to secretary to be left in the examining room. Is this subject to PAAB review? With that poster there will be a card to be given to the patient by the doctor with the same message and a call to action (talk to your doctor) is this also subject to PAAB review?

Question 104

Wed, 22 Oct 2025 21:01:16 GMT

If a disease education piece is being submitted (pre-NOC) that contains no branding and no mention of drug or treatment, would a review paper be an acceptable reference?

Question 105

Wed, 22 Oct 2025 21:01:14 GMT

Je travaille pour une agence de publicité et nous devons préparer un lancement de produit pour un produit pharmaceutique en vente libre, sous restriction, behind the counter (annexe II). J'aimerais svp avoir les réglèments publicitaires à respecter pour chacune des provinces.

Question 106

Wed, 22 Oct 2025 21:01:12 GMT

If the US indication is the same as the Canadian one, but the US Product Monograph is more comprehensive can it be cited instead?

Question 107

Wed, 22 Oct 2025 21:01:10 GMT

For a launch product is the review time the same as an old product line. When a pharmaceutical submits to PAAB the promotional pieces needed at NoC does PAAB take their 10 full days for review or is it possible to take half of the time because it is a product in launch mode.

Question 108

Wed, 22 Oct 2025 21:01:07 GMT

The PAAB code says that we cannot refer to Health Canada or the approval process for drugs in our advertising, and the reasons are obvious. But why can't we say "for all approved indications" when a product has a number of different indications?

Question 109

Wed, 22 Oct 2025 21:01:05 GMT

Under the current system, PAAB surveys are sent to the administrative staff who perform the work of submitting efiles. Can they be directed to the creative staff who perform the work of writing and responding to the letters?

Question 110

Wed, 22 Oct 2025 21:01:03 GMT

We would like to develop a schedule table for a multi-dose regimen of a vaccine and provide it to customers in a fridge magnet format. No product name or branding will be included, but it will be labelled as being provided as an educational service by company X. The content would be submitted for PAAB review.Is the fridge magnet format acceptable to PAAB?

Question 111

Wed, 22 Oct 2025 21:01:01 GMT

If a client was to state its indication along with a logo on an electronic web banners, does it needs to be approved by PAAB? As well, does it need to have a click through to PAAB?

Question 112

Wed, 22 Oct 2025 21:00:59 GMT

As a private clinic we are planning to prepare advertising material to be played on TV only to the patients waiting in the waiting area. The contents of these ads will be prepared by specialists in different medical disciplines. This will mostly contain OTC, NHP products. Is this activity subject to PAAB review?

Question 113

Wed, 22 Oct 2025 21:00:57 GMT

We have a journal ad that will be produced in several sizes (regular, tabloid, and 5"x9") does every size need to be submitted to PAAB for review. note that the message is exactly the same only the size changes.

Question 114

Wed, 22 Oct 2025 21:00:55 GMT

Does PAAB have any oversight on companies that advertise a system for treating periodontal disease through use of non-proprietary antibiotics among other diagnostic and treatment protocols?

Question 115

Wed, 22 Oct 2025 21:00:53 GMT

Can you confirm for branded, paid search campaigns, if you're able to: 1.Link the branded ad to both condition and brand name together as keyword terms? For example, "cholesterol Lipitor" 2. Link the branded ad to general terms such as "corticosteroids treatment"? The keyword would trigger a branded text ad that would then link to a DIN-protected, branded site.

Question 116

Wed, 22 Oct 2025 21:00:51 GMT

We want to produce a sticker that will say : NEW INDICATION. This sticker will be distributed to representatives to be applied on several promotional items that have gone through the PAAB for approval. Does this sticker need to go through PAAB for approval?

Question 117

Wed, 22 Oct 2025 21:00:48 GMT

I presently manage a small graphics studio and printing company and have been asked by one of my clients to arrange to get PAAB approval for certain Pharmaceutical Detail aids, Brochures and other related materials. I would like to know how to go about registering either my company or myself to be able to submit to PABB for approvals in the near future.

Question 118

Wed, 22 Oct 2025 21:00:47 GMT

Under what circumstances would it be acceptable to use a peer-reviewed, published study for a schedule F drug if that study uses a dosing regimen for the companion drug (always prescribed together but not subject of advertising, nor manufactured by the same company) that is inconsistent with the product monograph?

Question 119

Wed, 22 Oct 2025 21:00:44 GMT

Does regulatory permit placing a link on an unbranded condition website that drives visitors to the associated corporate website? The link would direct users to the corporate home page.

Question 120

Wed, 22 Oct 2025 21:00:42 GMT

We are considering producing a patient brochure in an alternate language other than french or english that remains valid until mid 2010 by PAAB. I understand that PAAB does not require a review if this is simply a translation and printing however in the last two months the Merck logos and trademarks have changed. If we change the trademarks/logos on this brochure do we require an additional review seeing as we are only changing the logos to reflect the new company name and then printing this new language which would have the same mid 2010 expiry date. Content of the brochure will not be changed.

Question 122

Wed, 22 Oct 2025 21:00:40 GMT

If a pharma company with an OTC or BTC product creates a private branded website that is password protected and accessible only by physicians, it is understood that all company generated content on the site would be subject to PAAB review and approval. However, if the site also allows for user generated content such as discussions between physicians, physician blog posts, or other physician generated questions or commentary, how might this type of dynamic activity and content be viewed by PAAB? Particularly given this type of content would be in constant evolution. Please note that this content would be viewable only by registered Canadian physicians. Any advice or direction would be appreciated.

Question 123

Wed, 22 Oct 2025 21:00:38 GMT

We were wondering whether there are potential issues with using the same patient visuals across both healthcare practitioner and patient materials. The patient materials would be mainly patient information pieces for those who are already on the drug.

Question 124

Wed, 22 Oct 2025 21:00:36 GMT

Can we use the same visual/design for a new product launch that was used pre-NOC in editorial pieces? The visual/design has not been used in other countries or jurisdictions so not linked to any product.

Question 125

Wed, 22 Oct 2025 21:00:34 GMT

Most brands have quite lengthy balance and we are looking on how to incorporate this into banner ads that include product claims. If the banners are animated and they rotate/transition automatically from claims to balance, is that okay. This would be the same as turning pages in a detail aid....correct?

Question 126

Wed, 22 Oct 2025 21:00:32 GMT

If a product that has NOC (i.e., without conditions) but does have a black box warning, how prominent do the indication statement and black box warning need to be? We would like to include both in the fair balance section of the piece, but wonder if either text needs to be placed elsewhere in the piece as well.

Question 127

Wed, 22 Oct 2025 21:00:30 GMT

On the website: http://fightosteoporosis.ca/ the copyright notice says: "Copyright C 2010 A research based pharmaceutical company" This doesn't seem right to me, I would expect a copyright notice to clearly state the site's owners. Investigation shows that the site is operated by Warner Chilcott (who market Actonel) but a lot of digging is necessary to get that information.Is this on-side with PAAB regulations?

Question 128

Wed, 22 Oct 2025 21:00:28 GMT

We are considering creating a web site that is for healthcare professionals (HCP)only. What are the minimum requirements for 'gating' the site? As this may span multiple products, DIN is not appropriate. We will be looking to use a UserID/Password combo. What is our responsibility as a pharmaceutical company to ensure that the person signing up for an account is indeed a HCP? Can it be as simple as getting the HCP to agree to the 'Terms of Use'?

Question 129

Wed, 22 Oct 2025 21:00:26 GMT

Can sales representatives distribute Congress reports? The congress reports are commissioned by a pharma company to a third party ( ex medical communications company). Information is not focussed on company brands and is balanced and independently produced.Do these reports need to go to PAAB for reps to be able to distribute?

Question 130

Wed, 22 Oct 2025 21:00:24 GMT

For a DTC help-seeking message for a preventative product (e.g. vaccine), can the name of the manufacturer appear on the ad?

Question 131

Wed, 22 Oct 2025 21:00:22 GMT

I have a question about the permissibility of the phrase "treatment-free" within the following context. If we are promoting a type of treatment with product X, where the patient takes product X for 2 weeks and then does not have to take the medication again until 50 weeks later (i.e. the following year), would we be allowed to say that the patient was treatment-free for those 50 weeks. Product X has a short half-life and is out of the patient's system within 24 hours so the patient would not be receiving treatment for those 50 weeks. Other treatments for the same disease are weekly or monthly, thus discussing the "treatment-free" portion of the treatment regimen is a point we would like to discuss with HCP and patients.

Question 132

Wed, 22 Oct 2025 21:00:20 GMT

A variation to question #89. An international speaker has been asked to make a presentation to a Canadian meeting of healthcare professionals about a product which has recently received its NOC. Her talk is not accredited, or about the disease category, but is focussed on the product itself which is mentioned by brand name. The slides, which are not printed out for distribution at the meeting but used onscreen, are prepared by the speaker and not by the sponsor. Do the slides require PAAB preclearance?

Question 133

Wed, 22 Oct 2025 21:00:18 GMT

Can a non-gated medical journal web site, whose online advertising is restricted to reminder ads and non-pharma ads, offer unrestricted access to a complete digital version of back issues of the journal (Rx advertising would appear as it does in print)?

Question 134

Wed, 22 Oct 2025 21:00:16 GMT

I'm puzzled by an ad on the cover of a specialist journal, announcing that a product is now availabile in Canada. There are no other claims or description of the product, other than suggesting the physician call the pharma company for more information or samples. I'm puzzled becuase the ad has no balance copy, no warnings, and has not been PAABed; there is no prescribing information. The company must feel that the ad falls out of the scope of the PAAB Code, but i don't see any of the exemptions applying. Plus, launch is a time when MDs are particularly in need of info regarding safety information. The masthead says that all drug ads have been cleared by PAAB, but this is clearly not the case. Is there something I am missing?

Question 135

Wed, 22 Oct 2025 21:00:14 GMT

I am developing a web site to host presentations of specialists to family physicians. The website will be gated to only allow physicians and the presentations will be accredited by the College of Family Physicians and produced independently by the speaker. There will be space for physicians' comments as well discussion forums focussed around the the topics being presented. I will seek pharma sponsorship of the presentations and will declare the sponsorship on the pages where members access the presentations. Will the slides require PAAB approval and do you see any hurdles that I may face in this endeavour?

Question 136

Wed, 22 Oct 2025 21:00:12 GMT

I would like to ask if my blog which contains plenty of pharmaceutical advertisements, matches with the code of ethics in Canada. On the other hand, could I add the logo of PAAB to my blog if approved.

Question 137

Wed, 22 Oct 2025 21:00:10 GMT

Would there be an issue with an online banner ad that is exempt from PAAB review linking through to a PDF of the products' Product Monograph?

Question 138

Wed, 22 Oct 2025 21:00:08 GMT

In your answer to Question 137, you are saying that although it goes beyond name, price & quantity, the PM (in its entirety)is not considered advertising. So is it acceptable to link the PM to the banner ad in the consumer realm?

Question 139

Wed, 22 Oct 2025 21:00:06 GMT

With regard to a diagnostic manufacturing company that manufactures glucose meters, etc. The company produces detail aids, etc. Do these detail aids require PAAB approval?

Question 140

Wed, 22 Oct 2025 21:00:04 GMT

If we place an ad in an HCP-focused journal, and provide a link to an HCP-focused website (either typed in or scanned using a 2-D scan code), can we assume that the audience has been sufficiently vetted as HCPs and provide branded drug information to them? This would be in lieu of asking for licence numbers or other means of identification.

Question 141

Wed, 22 Oct 2025 21:00:01 GMT

Can a pharmaceutical company have an SMS text message medication reminder sign-up on a DIN-protected website where patients can sign up for a daily SMS reminder to take their medication?

Question 142

Wed, 22 Oct 2025 20:59:59 GMT

If we are providing co-pay assistance program through a third-party, do communications informing physicians/HCP of the program have to go through PAAB?

Question 143

Wed, 22 Oct 2025 20:59:57 GMT

Is it permissible to give patients that have registered for an online patient support program, incentives or rewards to maintain their registered status? This is a DIN protected, branded site, that patients have registered and opted in to receive communications.

Question 144

Wed, 22 Oct 2025 20:59:55 GMT

Les publicitÃ©s de produits pharmaceutiques dans les mÃ©dias spÃ©cialisÃ©s (revue mÃ©dicales, associations professionnelles en santÃ©) doivent-elles Ãªtre accompagnÃ©es d'une monographie ?

Question 145

Wed, 22 Oct 2025 20:59:53 GMT

When is the time one can submit a docket before the Holidays? Are you open between Christmas and New Year's? If so, do you accept submissions at this time? Also, does the rule of 2 for initial docket submission still apply? Is the queue always 10 days for every first submission within that docket?

Question 146

Wed, 22 Oct 2025 20:59:51 GMT

[empty]

Question 147

Wed, 22 Oct 2025 20:59:49 GMT

I would like to understand what the average time (weeks/days) the PAAB currently are working to with respect to the review and approval of promotional materials from pharmaceuitical companies

Question 148

Wed, 22 Oct 2025 20:59:47 GMT

Can you provide an opinion on the use of reprints with information containing both within indication information and information outside of indication. The example would be a review article that has both, yet the direction to the sales force would be to highlight and promote the medical issue and the information consistent with the product's use and indication.

Question 149

Wed, 22 Oct 2025 20:59:44 GMT

We want to download our PAAB approved detail aid on an electronic pad for our reps to use. If there are no changes to the detail aid, do we need to re-submit to the PAAB? Second part is if the PAAB approved detail aid on the electronic pad has some interactive features such as animation of some charts or graphs do we need to re-submit it to the PAAB. If yes, in what format would it be submitted?

Question 150

Wed, 22 Oct 2025 20:59:43 GMT

In 3.1 you state claims must be consistent with,and within the limitations of, the Health Canada Terms of Market Authorization. I assume "consistent with" means similar to or paraphrasing what is in the PM. What "limitations" of the TMA are you referring to?

Question 151

Wed, 22 Oct 2025 20:59:41 GMT

If a pharma company sponsors a direct to consumer information (DTCI) site for Disease Awareness, can it talk about therapies (if they are all discussed equally, both drug and non-drug therapies)? I believe this to be "Yes". Assuming that, can the site also link from the therapy descriptions to branded drug websites as long as it handles all treatments equally?

Question 152

Wed, 22 Oct 2025 20:59:39 GMT

As per question no.150, can we make a Quality of Life (QoL) claim based on a published peer reviewed study (condition/use on label) when there is no QoL data in the PM?

Question 153

Wed, 22 Oct 2025 20:59:37 GMT

Can a pharma company place a product ad adjacent an editorial article in a healthcare journal if the article relates only to discussions about the condition that said product is labelled (no specific drug treatment mentioned)

Question 155

Wed, 22 Oct 2025 20:59:35 GMT

In the PAAB code 1.5, you note a few examples of what would qualify as PAAB exempt. Working within the parameters of drug name only not linked to therapeutic message, would saying that your brand has "no generic equivalent" be appropriate?

Question 156

Wed, 22 Oct 2025 20:59:33 GMT

Could a competitor product monograph or clinical study be used by sales reps during a call to answer a request? The info would be 'on label' and it would be for an unsolicited request (used reactively).

Question 157

Wed, 22 Oct 2025 20:59:31 GMT

Under what conditions / what is the criteria in which a pharmaceutical company is required to report an adverse event in the social media sphere?

Question 158

Wed, 22 Oct 2025 20:59:29 GMT

If the product trademark has changed from T to R, can the Sponsor change a previously PAAB approved material to reflect this trademark change without re-submitting to PAAB?

Question 159

Wed, 22 Oct 2025 20:59:27 GMT

If we were to have a backorder situation for one of our products and we wanted to inform pharmacies of this fact by way of a letter or fax to help prevent a backorder, would this letter/fax need to be PAAB approved? I was reviewing section 6.2 for clarification, and believe that it does not need submission to PAAB (I believe it's an institutional message), however I'm not entirely sure?

Question 160

Wed, 22 Oct 2025 20:59:25 GMT

What is PAAB?

Question 161

Wed, 22 Oct 2025 20:59:23 GMT

My submission now has the status "Response Required". How do I see the details behind this status? When I click on my submission, I only see the original submission and documents and no indication of what revisions or additional documents are required.

Question 162

Wed, 22 Oct 2025 20:59:21 GMT

Please advise as to whether there are any particular requirements related to a US manufacturer providing medical information letters to Canadian physicians' unsolicited requests for information for a drug not authorized for marketing in Canada. The letters would be intended only for medical information, not for advertising purposes.

Question 163

Wed, 22 Oct 2025 20:59:19 GMT

Is there any issue in company representatives handing out invitations to online medical education programs that have received accreditation?

Question 164

Wed, 22 Oct 2025 20:59:18 GMT

I intend to send out a PAAB-approved promotional piece to physicians in a direct mail campaign for an OTC product. I was also considering including a product coupon. The coupon will display the brand name, package shot and discount amount. There will be no claims. Should the coupon be submitted to PAAB, given that it will be distributed in the same envelope as a promotional piece?

Question 165

Wed, 22 Oct 2025 20:59:16 GMT

Would a cover/folder carrying the product monograph in its entirety (no edits, verbatim PM) require PAAB review? The cover/folder would have branding colors/ design (no implied claims) and simply state: "Brand X Product Monograph".

Question 166

Wed, 22 Oct 2025 20:59:14 GMT

If a pharmaceutical company was to sponsor a Canadian Association's medical educational piece, would this require PAAB approval?

Question 168

Wed, 22 Oct 2025 20:59:12 GMT

For our Vaccines web sites which are branded, we would like to include a link to our unbranded Digital Video News Release (DVNR) which will be housed on YouTube. We are also considering storing a PDF version of our unbranded matte stories on the website. Is there any concern with placing unbranded materials on a branded web site? Does it matter if it is a Vaccine or Rx product?

Question 169

Wed, 22 Oct 2025 20:59:10 GMT

Can PAAB provide some guidance on the use of physician quotes in promotional material? Can video clips of physician quotes be used at conferences?

Question 170

Wed, 22 Oct 2025 20:59:08 GMT

When introucing a new drug can we put the Health Canada classification, i.e. Angiotensin II receptor blocker or angiotensin receptor blocker of the drug on the same page as clinical information.

Question 171

Wed, 22 Oct 2025 20:59:06 GMT

If a physician who was not able to attend a congress/confrence(e.g. ASH, ASCO, ADA) requests through medical information slides on company studies presented at the congress are we allowed to provide them?

Question 172

Wed, 22 Oct 2025 20:59:04 GMT

Can we use a 2D / 3D scan tag, QR Code to carry the fair balance that may otherwise be physically attached to the collateral?

Question 173

Wed, 22 Oct 2025 20:59:02 GMT

Do personal (i.e. one to one, not mass generated) emails to HCPs announcing a product is "now available" need PAAB pre-clearance review? May such emails that mention a product also include brief mention of the general indication, disease state or therapeutic use? Thanks!

Question 174

Wed, 22 Oct 2025 20:59:00 GMT

Dear PAAB: Does inclusion of a product Name, and its associated DIN, adhere to name/price/quantity guidelines in c.01.044? Does package size (i.e. weekly, monthly and number of tablets) meet the regulations for quantity? Many thanks.

Question 175

Wed, 22 Oct 2025 20:58:58 GMT

Dear PAAB. What jurisdiction does PAAB have over reprints and in particular reprints that may not be acceptable for promotional material but are consistent with and within indication. An example would be a review article?

Question 176

Wed, 22 Oct 2025 20:58:56 GMT

Is there any guidance about websites designed for the provision of medical information to registered heath care profesionals in Canada. These sites are non-promotional and allow HCPs to access information after having completed a specific search on their own. The obvious advantage is to allow 24/7 access to information useful to help in patient care.

Question 177

Wed, 22 Oct 2025 20:58:54 GMT

We have a new product under review by Health Canada. A part of the approval is the preparation of the Risk Management Plan, which includes a slide deck for HCPs outlining the safety issues with the medication. Should this slide deck be PAAB approved? if yes, how do we go about this, given that PM is not yet approved?

Question 178

Wed, 22 Oct 2025 20:58:52 GMT

Does an ad for a medical imaging contrast agent need to be PAAB approved?

Question 179

Wed, 22 Oct 2025 20:58:50 GMT

I have a Patient Instructional Video for an Injectable Therapy. It has video footage that was developed originally in the United States and shows a Sharps Container that is Red in colour. In Canada, sharps containers are yellow. We would prefer to use the same footage for Canada. Is it acceptable to use a disclaimer in the video that states "In Canada, Sharps Containers are Yellow in Colour"?

Question 180

Wed, 22 Oct 2025 20:58:48 GMT

Could an online-only textbook (such as CCO InPractice) meet the requirements to be used as a reference for the PAAB? It is accredited for education by the AMA and is third-party to the drug company.

Question 181

Wed, 22 Oct 2025 20:58:46 GMT

I know that an on-label reprint distributed in a promotional context (ie by a sales representative) needs to conform with the PAAB Code, but does it need to undergo PAAB review?

Question 182

Wed, 22 Oct 2025 20:58:44 GMT

I am hoping that you can help provide us some guidance with respect to the use of "Now on Formulary" stickers. It is our understanding that such stickers are exempt from PAAB review as long as they are not linked to a therapeutic message in any way as per Section 6.6 d(ii) of the PAAB code. In the past when we have submitted such stickers to the PAAB, we have been asked to provide examples of where a sticker will be placed on previously approved APS. This occasionally becomes a problem when trying to assess viable placement options. For us, the guiding principles have been the following:

Question 183

Wed, 22 Oct 2025 20:58:42 GMT

Why is it that medical devices do not undergo the same scrutiny (PAAB approval) as prescription medications with regards to promotional tools?

Question 184

Wed, 22 Oct 2025 20:58:40 GMT

Do different guidelines exist for promotion of OTC brands to health care professionals with respect to the following:

Question 185

Wed, 22 Oct 2025 20:58:38 GMT

Can a cover tip ad cover the complete front cover of a medical journal? If not, what is the max. percentage?

Question 187

Wed, 22 Oct 2025 20:58:36 GMT

What type of guidance is there regarding the inclusion of product pipelines in Canadian corporate websites?

Question 189

Wed, 22 Oct 2025 20:58:34 GMT

Dear PAAB: We have a HCP-directed APS for a congress announcing "Company A name" and "Product B name" are "now here" in Canada. An offer to "visit at Conference Booth XXXX" is included. There are no further product / therapeutic claims. Is this exempt from PAAB preclearance review, as per the "now available" exemption in S6.6?; and If so, may we include product branding elements / visuals and maintain exemption? Thanks!

Question 190

Wed, 22 Oct 2025 20:58:32 GMT

Hi there, If a company wants to write a private letter to MPs, Senators, government officials (elected or appointed) with regards to their product, issues a company is facing with regards to approvals/existing regulations/legislation etc, does that letter require PAAB approval? To what extent are pharmaceutical companies required to submit letters to government officials to PAAB for review/approval?

Question 191

Wed, 22 Oct 2025 20:58:30 GMT

I understand that a Canadian consensus guideline is an acceptable, authoritative source. Correct? If the consensus is published in a peer-reviewed journal, but it is not explicitly called a "guideline" in the title, is this acceptable? (E.g., "Canadian consensus on..." or "Canadian clinical guidance...")

Question 192

Wed, 22 Oct 2025 20:58:28 GMT

Is it necessary, whenever a letter pertaining to your product is sent to a government official (either elected or part of the public service, at all levels of government) to include a copy of the Product Monograph if you refer in passing to an issue you may be having as it relates to your drug. For example, if we were bringing to the attention of Minister XYZ about Product A not being approved fast enough by internal bodies to meet the demands of physicians/patients, would we then have to include the PM simply because we mentioned the name of the product? Also, is it necessary, in private correspondence to government officials that is exempt from PAAB pre-clearance and non-promotional, to include both the generic name of said product, the dosing information, etc?

Question 193

Wed, 22 Oct 2025 20:58:26 GMT

Hi, If a company has a DIN for a human pharmaceutical, but does not have a vet DIN, are they allowed to advertise it, provided they are transparent that it is not vet DIN approved? Thanks!

Question 194

Wed, 22 Oct 2025 20:58:25 GMT

If a DIN-gated patient website has been approved, can Sales Representatives showcase the website to physicians?

Question 195

Wed, 22 Oct 2025 20:58:23 GMT

If a company wants to make physicians aware of an optional training program by sending a letter, will the letter be reviewed by PAAB or it is content-dependamt? Any guidance on the training materials provided to physicians at the training?

Question 196

Wed, 22 Oct 2025 20:58:21 GMT

I understand a branded paid search ad cannot use keywords that go beyond name-price-quantity. However, if a person searches for the brand name keyword in conjunction with the disease-state keyword, does this not identify them as a patient or someone who is already knowledgeable about the product? Could a branded ad be presented if the searcher has already made the brand-disease connection themselves?

Question 197

Wed, 22 Oct 2025 20:58:19 GMT

When submitting a file for review by the provincial governments for the purposes of securing or improving reimbursement status, do any of the materials need to be submitted to PAAB? Thank you for your help.

Question 198

Wed, 22 Oct 2025 20:58:17 GMT

Dear PAAB, We have been asked to prepare a slide presentation for our sales reps to use for group presentations to customers. These events vary in length from 20 to 60 minutes. It is not possible to create a separate slide presentation for each event. We propose a 'core' deck with the essential safety and efficacy information, and an 'enhanced' or 'expanded' deck with additional published data. Both would be PAAB-approved. In cases where there was insufficient time to present the larger presentation, the core slides would be presented and would be supplemented with a number of slides from the PAAB-approved 'expanded' presentation. Is it possible to use 2 approved slide decks in this manner? If so, how should they be submitted to PAAB for approval. Thanks for your interest.

Question 199

Wed, 22 Oct 2025 20:58:15 GMT

How do you review electronic detail aids created for tablets/iPads? Which technical features can be included in electronic details that would allow for easier detailing over a tablet/iPad? - Search keywords - highlighting sections - animations - organizing content into tabs (dosing, safety etc)

Question 200

Wed, 22 Oct 2025 20:58:13 GMT

I am a Strategic Account Manager for a Pharma Company in Toronto. My clients are Director Level and higher in Hospitals and we would like to produce a slide kit for meetings with Hospital Executives which provides information on our company (history, mission statement, values), examples of unrestricted educational grants that have been requested by organizations, information on our supply chain process and stability, PAAB approved educational & safety booklets for HCP and patients and a list of our hospital products which are approved for sale in Canada. The presentation will not include an product claims or promotional statements. Based on the PAAB Code, please confirm if this presentation is exempted from PAAB Review as it does not contain any communications in which claims, quotations and references are made for healthcare products.

Question 201

Wed, 22 Oct 2025 20:58:11 GMT

Does a letter announcing provincial listing for a drug need to be PAAB'd? The letter will be a direct mailing from the pharmaceutical company to HCPs in the province announcing the listing, reimbursement criteria and indication of the product.

Question 202

Wed, 22 Oct 2025 20:58:09 GMT

We would like to reference other clinical studies from independent researchers relating to our product. Purpose is to highlight other research results & findings on different groups of patients. Research has been submitted with the PLA to support other claims used on the packaging but this research claims additional benefits. Am I able to use this research to state the results from these studies without it being in conflict of the claims made on the packaging/PLA? Please advise.

Question 203

Wed, 22 Oct 2025 20:58:07 GMT

Hello, i am looking for an official definition of on-label as it relates to conversations that a pharma rep can have with a HCP. Although all material need to be PAAB-approved, verbal exchange in the office can touch on latest data publicly available, such as posters, conference reports, etc. If referring to approved dosage, patient population and condition, can the reps discuss this with physicians in an effort to have robust clinical and scientific discussions... best regards

Question 204

Wed, 22 Oct 2025 20:58:05 GMT

Bonjour, Article 3.5.1 du Code indique Le corps du texte doit faire référence aux résultats négatifs d'une façon nettement visible. Qu'entend-on par résultats négatifs? Comment interpréter ou comprendre cela alors que pour notre catégorie de médicament, aucun effet négatif n'apparait à la licence de mise en marché (DIN-HM). Je vous remercie par avance pour votre réponse?

Question 206

Wed, 22 Oct 2025 20:58:03 GMT

Under what circumstances would it be acceptable to claim that two arms of a clinical trial have similar side effect profiles? Does it only relate to the type of most commonly reported adverse drug reactions in each arm or must the incidence also be comparable?

Question 207

Wed, 22 Oct 2025 20:58:01 GMT

If only US data is available for a particular disease, is that acceptable by PAAB?

Question 208

Wed, 22 Oct 2025 20:57:59 GMT

Hi there I was wondering if we would need to PAAB-approval formulary announcements to physicians if conditions for benefit on the formulary in their province are to be listed in the announcement. Example for coverage on provincial plan: Patients are over 4 years old. Cared by a physician experienced in managing seizures associated with LGS. Already on two or more antiepileptic drugs in whom topirimate, lamotrigine and other expensive drugs are ineffective or inappropriate. Thank you

Question 209

Wed, 22 Oct 2025 20:57:57 GMT

I work for a drug company and want to sponsor a grant for the Patient groups to reach out to patients to videotape their journey through their disease and experience with a new treatment they are on (our drug). We will be hands off for details and production of this video and it will be put on their site to share with other patients -- do we need to tell them to PAAB the video and are their any other requirements we need to follow? Can we also post a link to their site with the video? Thank you very much!

Question 210

Wed, 22 Oct 2025 20:57:55 GMT

Would PAAB approval be required for cards containing the Ontario Drug Benefit (ODB) Reimbursement Codes for a drug class? *content is copied verbatim from the ODB website *OBD website/URL is referenced *no mention of drug name or drug logo *no mention of pharmaceutical company *to be distributed by drug rep

Question 211

Wed, 22 Oct 2025 20:57:53 GMT

Since Jan 2009 Q&A, is there update further to question #84 on distribution of reprints and Health Canada/PAAB postiion?

Question 213

Wed, 22 Oct 2025 20:57:51 GMT

Dear PAAB, I am curious about creating unbranded educational material around Subsequent Entry Biologics. We know that there are potentially a lot of issues that SEBs can have considering the nature of the manufacturing process. Is it acceptable to educate physicians on the challenges, risks, and non-identical nature of SEBs vs. orignial product, using review and 'expert opinion' articles in an unbranded piece? Alternatively, if we had a study that was done that showed these issues would we be able to use that? Or is it, if Health Canada has approved it then we can't say anything to infer challenges and risks? Many thanks.

Question 214

Wed, 22 Oct 2025 20:57:49 GMT

Do the same rules apply to unbranded materials as branded? For example, Can I use review papers to discuss disease category education? What materials are acceptable to use as reference? Thank you!

Question 215

Wed, 22 Oct 2025 20:57:48 GMT

Dear PAAB Can a sales rep distribute a patient booklet that has been independently created by patient group? Can they distribute the booklet if their company sponsored the creation of the booklet? Many thanks.

Question 216

Wed, 22 Oct 2025 20:57:46 GMT

Would a RX script pad require PAAB approval? The pad will contain taglines from a PAAB-approved ad. Thank you.

Question 217

Wed, 22 Oct 2025 20:57:44 GMT

We are holding a patient conference where there will be sponsoring companies exhibiting. Some are companies that have Rx products and some are companies with OTC products. What are the guidelines for the exhibitors in both cases? What are the limitations, in particular, for the Rx product companies with respect to promoting their therapeutic products? The audience is a mix of patients who have several different diseases, as well as the general public.

Question 218

Wed, 22 Oct 2025 20:57:41 GMT

Dear PAAB, We are interested in building a small electronic questionanire that reps will use to ask the doctors some questions about how they feel certain things are a problem in their practice when managing their XXX[disease state] patients? The questionnaire would be unbranded, make no mention of any treatments. Would this be considered PAAB exempt?

Question 219

Wed, 22 Oct 2025 20:57:40 GMT

Hi Patrick. We're looking to place a card within packs of our prescription product, directing patients to our website. The card will contain no promotional claims. Only content would include: product and company name. Please go to www.xxxxxxxxxx.com Since the piece will essentially be part of the product packaging, I wanted to ask if this would fall under review of PAAB or HC? Also, as there are no product claims, would this be exempt from review? Thanks!

Question 220

Wed, 22 Oct 2025 20:57:38 GMT

A couple colleagues have recently indicated that Annotated Product Monographs are beginning to be subjected to more stringent restrictions by the PAAB. Both indicated that the reason was that by calling out certain elements of the product monograph that it was creating "undue emphasis" on product attributes. This raises two questions: 1. How does this differ from a typical sales aid whereby charts and compelling data points are given emphasis and fairly balanced with appropriate safety information, etc. AND 2. Doesn't the fact that an annotated Product Monograph contains all pertinent balancing information in one easily accessible tool not by default ensure that appropriate caution was exercised in highlighting data? Furthermore, is this a recent development? I can recall within the last 2 years working on several of these tools with no such objections from the PAAB. Thanks in advance for your reply!

Question 221

Wed, 22 Oct 2025 20:57:36 GMT

Reading Q&A section, I understand that advertising to HCPs, although voluntary, falls under PAAB. Where would we go to clear advertising to the consumer? I usually work with food, so it is new for me to work with NHPs and I would like to do this correctly. Thank you.

Question 222

Wed, 22 Oct 2025 20:57:34 GMT

What are the restrictions regarding reporting on efficacy in a clinical trial in our news releases? We will be issuing a news release when we receive NOC. We want to say what improvement in patient health was observed in the trial. The trial compared our drug to placebo. How can we explain what happened?

Question 223

Wed, 22 Oct 2025 20:57:32 GMT

Hi, In the past we produced a branded APS presenting ongoing off-label trials. This piece was reviewed and approved by PAAB. Recently, we looked at the PAAB code and found that mentions of ongoing trials were acceptable in a non-promotional context. We have 2 questions: 1. Did the code change regarding the mention of ongoing trials? 2. Can you describe or give an example of a non-promotional context (unbranded material?)? Thank you

Question 224

Wed, 22 Oct 2025 20:57:30 GMT

I have been contracted by an agency to help develop a program for doctors on a product for an arthritic condition with a high indication of depression and anxiety in patients. No claims are made in the program regarding the drug. The program simply offers education and tools on depression and anxiety in these patients with this arthritic condition. What are the PAAB guidelines that must be adhered to in this program? Thanks!

Question 225

Wed, 22 Oct 2025 20:57:28 GMT

Hello, I work for a medical communications agency. We were given a restricted educational grant to develop a program which falls under the category (as per Rx&D) 'Other Learning Program'. It follows the CME guidelines but is not accredited. The program sponsor did not have any involvement with the development of the program content. It was developed by the steering committee of specialists. The program is unbiased in nature. Treatment options for the condition in question are mentioned but not the drugs themselves. The distribution of the program will be via a direct mailer to the target audience that drives the audience to a web site where the program is housed - sales representatives are not involved in the distribution. Please confirm if this requires review/approval from PAAB.

Question 226

Wed, 22 Oct 2025 20:57:26 GMT

I have been contracted by CTC Communications to aid in developing an application program on a product for a chronic arthritic condition with a high indication of depression/anxiety in patients. Like most chronic illnesses, the incidence of a mood disorder is high - this has nothing to do with the drugs treating the arthritic condition (i.e. the drugs are not causing or treating the mood disorder). In this program, no claims are made regarding the product (i.e. no claims are made that the drug helps depression/anxiety), it simply offers education and rating scales on depression/anxiety. Does this program need to be PAAB approved? Furthermore, what elements of the program need to be passed through PAAB? The elements include: *Content in the application *Information handout on the application that the representative may leave with the physician *Paper or e-detail on the application that the representative may use to detail the physician on the application Thank you for your feedback in advance.

Question 227

Wed, 22 Oct 2025 20:57:24 GMT

Just saw a tv ad on CANADIAN tv (Sportsnet) for zostavax, referring viewers to zostavax.ca and it very obviously promotes it for prevention of shingles. How is this not a violation of DTCA regs?

Question 230

Wed, 22 Oct 2025 20:57:22 GMT

Hello, I am developing a free iPad application that provides healthcare education presentations for HCPs only. This app will be available for download from Apple's app store. What kind of user gating am I required to have for this app? Is a disclaimer + check box certification of the HCP status enough? Furthermore, I have heard about new sections being implemented in the PAAB code that are related to this - possibly referred to as "access control". Do you have any information concerning these guidelines? Thank you!

Question 231

Wed, 22 Oct 2025 20:57:20 GMT

Is it permissible to advertise for sale NHP's or OTC's to the general public via such media as The Home Shopping Network? Are there any restriction that a distributor should be aware of?

Question 232

Wed, 22 Oct 2025 20:57:18 GMT

Are sales representatives are allowed to detail on unbranded disease messages, and product-specific messages for this disease in the same sales call, even if the messages are presented in separate APS? I'm concerned about the concept of linking unbranded messages to branded claims.

Question 233

Wed, 22 Oct 2025 20:57:16 GMT

Cosmetics are not in the scope of the PAAB code unless they are medicated or hypoallergenic. I assume that any medicated have a DIN or NPN. Is this also true of products with a hypoallergenic claim? We have a Cosmetic (no DIN, no NPN)in our portfolio that the company wants to detail to HCP. As such, HCP specifc promotional material is being created. Despite the fact that cosmetics without a DIN or NHP are outside the scope of PAAB, does the fact that the promotional material is directed to HCP mean it should be reviewed by PAAB or would this still fall under ASC? Thank you for your assistance.

Question 234

Wed, 22 Oct 2025 20:57:14 GMT

Can a company display disease state educational materials at a booth at a conference in which the company does not have any marketed compounds (i.e. a disease awareness booth)?

Question 235

Wed, 22 Oct 2025 20:57:12 GMT

Dear PAAB: We have both unbranded and branded APS approved by PAAB. What are suggested and appropriate mechanisms for unbranded (HCP:patient teaching tools) and branded APS to be distributed by sales representatives, so as to not create linkage between the pieces? Are separate calls (branded and unbranded) appropriate? Is distribution of the unbranded APS (i.e. by request form, business reply card etc.) with follow-up by the sales representative specifically to discuss the unbranded APS, an acceptable way to separate the pieces?

Question 236

Wed, 22 Oct 2025 20:57:10 GMT

I am working on an unbranded piece speaking to medication adherence in general. Can I put product logos (without indication or claims) on it if the content does not cover indications or treatment in any way?

Question 238

Wed, 22 Oct 2025 20:57:08 GMT

Hi PAAB: Educational material on disease state is being put together in an APS for doctors to distribute to appropriate patients, after the doctor has educated the patient on the disease state. The doctor will provide the handouts to the patients at his/her discretion. Is inclusion of a branded section on how to use the product allowable for this APS?

Question 240

Wed, 22 Oct 2025 20:57:06 GMT

Hi, I was told that an unbranded piece that would be in a waiting room would be direct to consumer, and those which would be in the doctors office are direct to patient. Is this correct?? IF SO, then what are the differences in terms of regulations? For example, what can be said in an unbranded piece in a waiting room that cannot be said in a piece designed for the doctor's office?

Question 241

Wed, 22 Oct 2025 20:57:04 GMT

When PAAB approves a submitted piece, it provides an approval identification number. Can you advise me as to the configuration of that number? How many characters is it? Is it an alpha-numeric configuration? We are formatting a cloud-based internal review system and would like to capture our PAAB approvals accordingly. Thank you.

Question 242

Wed, 22 Oct 2025 20:57:03 GMT

If we were to develop an unbranded DTC help-seeking ad (in which the pharmaceutical sponsor WOULD NOT be disclosed) - can the ad link to a DTC, disease-state website, in which the pharmaceutical sponsor IS disclosed? The disease-state website has been previously approved by PAAB.

Question 243

Wed, 22 Oct 2025 20:57:01 GMT

If a product has multiple indications, but we are developing a promotional piece for just one of those indications, does the fair balance copy still have to contain all indications and balance copy for ALL the indications? Thank you.

Question 244

Wed, 22 Oct 2025 20:56:59 GMT

1. Is there a preference as to which comes first after a claim: the symbol (e.g. *) or the footnote number (e.g. 1)? "My product was tested and found to work."*1 or "My product was tested and found to work.1* 2. Should these be superscripted or just keyed in in a regular font (e.g. *) 3. Is there a separation required between footnote numbers and symbols? "My product was tested and found to work."1,* In AMA (American Medical Association) format the reference number would come first, separated by a comma, then the footnote symbol. The referencing would be superscripted. "My product was tested and found to work." 1,*

Question 245

Wed, 22 Oct 2025 20:56:57 GMT

It seems to be standard industry practice to post the Product Monographs for pharmaceutical drug products on the corporate websites. There are no ancillary messages provided with these, just the links to the full texts of the product monographs. In addition, these PMs are available through Health Canada's Drug Product Database to anyone who searches, and these are unrestricted. However, I understand that PAAB reviews company prepared websites specific to products, even if they only contain information straight from the PM without any editing. If it is okay to post the PMs on the corporate websites and other publically available portals, why do the designated product websites that only contain the PM information require PAAB review? Thanks!

Question 246

Wed, 22 Oct 2025 20:56:55 GMT

Are unbranded printed materials focussing on disease area with no mention of drug treatments and that are presented to Health Care Professionals by Sales Representatives exempt from PAAB review?

Question 247

Wed, 22 Oct 2025 20:56:53 GMT

Could we use global data to support a worldwide market share claim which would include Canada? or is this something that can be confirmed by the sponsor's Med/Reg Department e.g. Drug X: Over 1.5 million patients worldwide.

Question 248

Wed, 22 Oct 2025 20:56:51 GMT

Is it acceptable to have a multiple choice practitioner-poll if the statements are not in any way therapeutic claims? The data collected is presented but will not be utilized in claims.

Question 249

Wed, 22 Oct 2025 20:56:49 GMT

This isn't really a question, but it would be great if PAAB were able to send an automatic email out 2 months before expiry on electronic media/websites. I am sure this is an easy thing to tag to the submission database and would be of great value to agencies and clients. Perhaps it is something that users can opt in to if there are any concerns. I hope you will consider this.

Question 250

Wed, 22 Oct 2025 20:56:47 GMT

In addition to the automatic renewal email I just submitted, it would be AMAZING if the final PAAB approval letter (or final communication letter -- for both languages if applicable) was included in the eFile library along with the historical files. There is so much turnover in agencies, it would be incredibly helpful to have a complete document history in one location to help alleviate anything slipping through the cracks.

Question 251

Wed, 22 Oct 2025 20:56:45 GMT

The Code (in part) states: 1. that patient information is exempt from PAAB review if the information is direct from and consistent with the product monograph. 2. patient materials must be non-promotional. The questions, • if by PAAB's interpretation, would the content of PART III of a product monograph be exempt if produced in a multipage brochure layout, accompanied by product branding elements (colors, graphic design, brand logo, etc). • if a brochure layout is acceptable, then may the formatting be comparable, or are there restrictions or requirements related to formatting treatments for section titles, italics, bolded fonts, underlined text, etc.

Question 252

Wed, 22 Oct 2025 20:56:43 GMT

Do they have a PAAB expiration of 1 year (i..e, do we need to renew annually)?

Question 253

Wed, 22 Oct 2025 20:56:41 GMT

Are there restrictions on the use of the Australian flag in advertising?

Question 254

Wed, 22 Oct 2025 20:56:39 GMT

I'm curious as to why the STI Innovicares program is allowed to advertise specific brand name drugs on a website without PAAB review; especially given two main pharmaceutical companies are behind a large promotion of their brands (AZ/Sanofi)? Isn't this considered DTC advertising linked to brand name drugs? The website is at www.innovicares.ca and also has DTC ads and posters in addition to the website.

Question 256

Wed, 22 Oct 2025 20:56:38 GMT

Is there a ratio needed between the graphic display (image) and the monograph font size?

Question 257

Wed, 22 Oct 2025 20:56:36 GMT

Would a natural OTC Supplement (no DIN number) require PAAB approval for promotional materials targeted to HCPs? Would consumer advertising require PAAB and/or ASC?

Question 258

Wed, 22 Oct 2025 20:56:34 GMT

I am seeking clarification on the recent PAAB advisory Jan 10 2013. If the "Now on Formulary" has codes which we include in the announcement is this still exempt? Secondly if we include codes and incluson criteria is this exempt. Thirdly if not exempt, do we then have to have full PI accompany the Ad. The latter adds significant cost to a relatively simple message. Finally is the inclusion of details on the special authorization or codes mandatory? It would appear from your memo it is at the discretion of the company? Thank you.

Question 259

Wed, 22 Oct 2025 20:56:32 GMT

Are there any guidelines (outside of color preference) for placement of the PAAB logo on an approved piece? Is there a size limitation of the logo or a desired location (front vs. back side) we should consider? The website is not loading the PAAB logosheet PDF unfortunately?

Question 261

Wed, 22 Oct 2025 20:56:30 GMT

A company is considering a patient support program. Before proceeding, they wish to conduct a pilot program that has been designed by an expert steering committee of specialists in the therapeutic area. Informed consent would be required from patients and the treating physician would give the information to the patient. During the course of treatment, the patient consent would include an agreement to be contacted by a PIPEDA-compliant CRO to collect information regarding the relative utility of the patient materials. The data would then be used to create the final program. The question is do the materials provided during the pilot stage need to be cleared by PAAB? It is understood that the final materials would be submitted to PAAB. Thank you for the opportunity to present this via the site. Excellent feature.

Question 263

Wed, 22 Oct 2025 20:56:28 GMT

Has the PAAB ever considered a "priority review" stream, whereby Clients could receive a shorter initial review (3-5 days vs 10) for a higher fee ($1000, $2000, etc)? There are occasions where guaranteed expedited timing is vital, and this option would serve the industry while generating additional revenue for the PAAB. To restrict use, Submission Coordinators could limit Files to those of formulary/safety content, or those of shorter length.

Question 264

Wed, 22 Oct 2025 20:56:26 GMT

Funtions of paab.

Question 265

Wed, 22 Oct 2025 20:56:24 GMT

Please explain "Claims relating to PRO endpoints must appear clearly within the context of the Health Canada approved indication." Does this mean that data from PROs must be in the PM, or just that the PM must address the outcome being assessed (e.g. "Drug X treats condition Y, and the pain from condition Y", for the PRO of pain reduction).

Question 266

Wed, 22 Oct 2025 20:56:22 GMT

If a journal ad highlighting a product portfolio (and therefore, includes product logos)were to make the following statement, would it be considered a claim of merit, if non-specific to any one drug: "[Company] committed to gastrointestinal care for over 80 years." If so, would the lowest level of fair balance suffice, according to the new PAAB Code?

Question 267

Wed, 22 Oct 2025 20:56:20 GMT

Can you create a url for your brand, that will be a password protected site, with the brand name and indication statement in it. e.g., maxaltmigraine.ca. The homepage for the site will be available to the public.

Question 268

Wed, 22 Oct 2025 20:56:18 GMT

Dear PAAB, We are developing a gated HCP website that requires the HCP to enter his/her license number to gain access to the site. Who provides the database of physician license numbers which our site will "ping" (cross-check against)? If it is an outside source/organization, is there any fee for this?

Question 270

Wed, 22 Oct 2025 20:56:16 GMT

In the US, promotional materials may use the term "new" for a period of six months from the first date of marketing by the company. Does the PAAB code or guidances have a similar requirement? (been searching but not finding).

Question 271

Wed, 22 Oct 2025 20:56:14 GMT

With the PAAB Approval comes an expiry date....is it a requirement to have this expiry date printed on the final promotional piece along with the PAAB logo? Or is it optional?

Question 272

Wed, 22 Oct 2025 20:56:12 GMT

We are developing a patient-directed instructional guide on how to use an injectable medication. The format is a flip chart, with visual instructions on one side (for the patient), and more detailed instructions on the reverse side (for the nurse's eyes only). Given the new PAAB code, and the fact that this is a HCP-delivered patient APS based on Section III of the product monograph, would the lowest level of fair balance suffice?

Question 273

Wed, 22 Oct 2025 20:56:11 GMT

Hi, I will be following PAAB regulations to ensure that an unbranded disease information piece qualifies as being 'PAAB exempt'. I will also be submitting it to PAAB (simply to get a letter saying that it is PAAB exempt). Is it necessary that the review papers we are referencing DO NOT make mention of treatement options anywhere as well (even though our APS will not make mention of treatment options/categories)? Or is it ok if the review paper discusses treatments so long as we dont make mention of them in the APS?

Question 274

Wed, 22 Oct 2025 20:56:09 GMT

I run a medical information line for patients and Healthcare providers for a pharma company. Do I need to either read or have on the front end recording the safety statement from the PI prior to speaking with the customer?

Question 275

Wed, 22 Oct 2025 20:56:07 GMT

Question 276

Wed, 22 Oct 2025 20:56:05 GMT

If you recorded a speaker event (sponsored dinner conference) and want to post it on a website, can you? What rules is the content subject to and what is acceptable in terms of efforts or means by which you would make HCPs aware of the availability of this recorded presentation?

Question 277

Wed, 22 Oct 2025 20:56:03 GMT

Assuming you can ensure that your web platform is only being accessed by Canadian physicians, what are the rules about the content that is on the website? Does the fact that the physician agrees to be "subscribe" open a channel to the information being PAAB exempt on the premise that the physician "Requested" this information? We are thinking of CME materials, disease-relation information (with and without drug mentions), videos of speaker conferences, etc.) We are also thinking of information about the sponsor's ongoing clinical trials.

Question 278

Wed, 22 Oct 2025 20:56:01 GMT

In an APS for a prescription product, if you want to present side-by-side comparisons of non-therapeutic information from Product Monographs (e.g., product properties, use limitations) as per section 5.10.2, do you need to include all of the approved products in that indication or is it acceptable to show only selected products (e.g., two out of five available agents)? If all products must be mentioned, does that also include generics or only branded products? Thanks!

Question 279

Wed, 22 Oct 2025 20:55:59 GMT

Dear Concern, What are the time lines and submission procedures in canada. what are the guidelines for OTS products in Health Canada (submission only)

Question 280

Wed, 22 Oct 2025 20:55:57 GMT

Is including the names of Rx products on sales rep business cards and email signatures allowed ? Or are these considered APS or potentially DTC advertising . Thank you

Question 281

Wed, 22 Oct 2025 20:55:56 GMT

Please confirm the approval process for French websites. We submit the English copydecks and layouts for approvals. Once approved, we then submit the French copydecks for approval. Does the French copydeck require French layouts or can we submit the French copydeck with the English layout?

Question 282

Wed, 22 Oct 2025 20:55:54 GMT

In the new PAAB code, it says: "The PAAB can allow the use of observational studies when specific acceptance criteria are met." What are the specific acceptance criteria? Also, does a natural history study fall under an 'observational study' or 'meta-analysis'? Thanks

Question 283

Wed, 22 Oct 2025 20:55:52 GMT

We are considering a partnership that will allow us to place unbranded, disease awareness information into a variety of large public health portals. The portals contain disease awareness information but also have separate areas that disseminate drug specific information. (We are not providing any drug specific information.) As part of this partnership, we are being offered the ability to have banner ads run throughout the site. The ads are not just for our unbranded content. There is the potential for us to have branded ads that point to our gated product-specific website. The banner ads are "run of site" and there is no influence on where they appear within the portal. There are two possible situations that we are concerned about. Our branded ad appears on a page where our unbranded disease information resides through random placement. Our unbranded disease awareness ad lands on a page which contains related drug information through random placement. These situations are out of control but may occur. Does this make us out of compliance with the spirit of the DTC advertising code?

Question 284

Wed, 22 Oct 2025 20:55:50 GMT

Hi Patrick! We're looking to collect data from a patient survey related to dosage and administration. Ultimately, we would like to disseminate this information to HCPs so they are more aware of their patient behaviour and preferences in relation to their treatment. Could you suggest a way we would be able to do this? Thanks

Question 285

Wed, 22 Oct 2025 20:55:48 GMT

Hi, I have a study (contained in the PM) in which only 2 versions of the same drug are being compared. The PM contains baseline and last visit levels of an endpoint marker for both drugs. In a branded detail aid, am I allowed to show a graph (baseline vs. last visit) for just one of the drugs? Or do I have to show the same type of baseline vs. last visit graph for both drugs? Thanks!

Question 286

Wed, 22 Oct 2025 20:55:46 GMT

After putting the NOC/c boxed statement on the front cover, can additional related statements go on the inside of the APS - or does it all have to appear on the front cover?

Question 287

Wed, 22 Oct 2025 20:55:43 GMT

PI, when required or when necessary, must form an integral part of the advertising message, which may be accomplished via a reference to a website link in a printed piece or by a direct electronic link to a website. If I am reading this correctly, as long it is placed on the ad page where they can find full prescribing information, I do not have to include prescribing information with my publication. Thank you

Question 288

Wed, 22 Oct 2025 20:55:41 GMT

If we are to conduct comparative analysis (our product vs. marketed products from the same category) to support a claim to be presented to HCP, what are the standards that the study and resutls should meet for PAAB to consider it acceptable?

Question 289

Wed, 22 Oct 2025 20:55:40 GMT

For a branded patient education brochures focused on disease/symptom management with only general (drug class-based, non-promotional) mentions of treatment, would disease-related information sourced from a national non-profit patient association be acceptable?

Question 290

Wed, 22 Oct 2025 20:55:38 GMT

We are placing promotional branded banner ads (no claims) in third party HCP gated websites that will drive traffic to our own gated HCP specific website. The third party site is intended for HCP's only. a) As the third party site audience is validated to be HCPs only, is this sufficient to enable bypassing our gating mechanism and bringing the HCP directly into our site? b) We are intending to bring the HCP to our top level product overview page. For future use, are there any issues with deep linking the physician into other areas of the website? (ex: Dosing, patient support, safety)

Question 291

Wed, 22 Oct 2025 20:55:36 GMT

My understanding is that advertising of medical devices such as injectors are not governed by PAAB. However, if a auto-injector can only be used with a specific medication, and one advertises the injector to consumers, is there not a direct association of device & drug? In other words, if the device is so closely connected to the drug, should it not also be subject to PAAB advertising rules, despite the fact that technically, it is a device, not a drug?

Question 292

Wed, 22 Oct 2025 20:55:34 GMT

Hi, I'm sending this request for clarification on the new PAAB code: section 3.1.6 of the new code states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of a product claim must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. compared to the previous code which states: 3.1.6 Footnotes in close proximity may be used to augment information presented in the body copy. Information that is important for a clear and accurate understanding of the indications or dosage of a product must not be relegated to a footnote. Example - an indication or dosage that is limited or that is restricted to a specific group of patients. can you please clarifiy the implications or give examples on how the new point 3.1.6 differs from the old one? thank You!

Question 293

Wed, 22 Oct 2025 20:55:32 GMT

A pharmaceutical company has provided an unrestricted educational grant for the development of a disease-focused patient website. Can sales reps distribute postcards promoting the website (site name, disease focus, URL)?

Question 294

Wed, 22 Oct 2025 20:55:30 GMT

Hello, I have a piece that is being reviewed and will likely be available before my required date of 1st use. Is it possible to align the PAAB expiry with the timing of use of my piece.

Question 295

Wed, 22 Oct 2025 20:55:28 GMT

Hi there, I was wondering if your review procedure for DTCA and DTCI advisory opinions occurs in accordance with chapter 8 and s 9.8 of the PAAB Code. More specifically, do you have the same rights to clarification by telephone or correspondence, meeting, escalation to the Chief Review Officer, and appeal? Thanks in advance for your answer.

Question 296

Wed, 22 Oct 2025 20:55:26 GMT

We understand how gating works for things like banner ads on sites where medical registration is required to log in. On sites where any user can purchase access (medical journals, for instance), or where large institutions like universities often have blanket access, is a post-login screen still considered "post-gate" for advertising purposes?

Question 297

Wed, 22 Oct 2025 20:55:25 GMT

Hi Patrick. Can you direct me to the section of the PAAB Code that outlines the potential for use of marketing research data / findings in an APS?

Question 298

Wed, 22 Oct 2025 20:55:22 GMT

We have a DTC/I campaign moving forward (disease awareness, unbranded). In the treatment section, there will be an outline the different medication options indicated for treatment of this disease. A listing of the benefits and risks associated with medication will also be listed. Because this is a DTC/I content and it contains a listing of ALL indicated products with no links to branded sites, we believe this to be PAAB exempt. What is your recommendation?

Question 299

Wed, 22 Oct 2025 20:55:21 GMT

We have videos that demonstrate how to use our product. The video is branded but does not extend beyond name, price, quanity. Is it acceptable to not gate this piece of information? If yes, are there any concerns with posting this on YouTube as a credible source on how to use our product?

Question 300

Wed, 22 Oct 2025 20:55:19 GMT

We are considering eMail marketing targeting our physicians in our campaign plans. We have several products in one therapeutic class. We would like to limit the number of emails sent to HCPs in order to be respectful of their time. Is it possible to send a single email with more than one brand in the email?

Question 301

Wed, 22 Oct 2025 20:55:17 GMT

Does clinical trial advertising material need to be precleared? If so, by who?

Question 302

Wed, 22 Oct 2025 20:55:15 GMT

If the audience is not hc professionals and not consumers- somewhere in the middle (private drug plan managers)- how should this audience be treated?

Question 303

Wed, 22 Oct 2025 20:55:13 GMT

According to the PAAB Guidance on Base Fair Balance Level Selection and Placement, the indication statement is not a 'claim' that requires fair balance. Therefore if an APS contained only the Drug name (including active ingredient and dosage form) and the indication statment, and no other explicit or implicit claims, would this APS require any fair balance? Would it be exempt from preclearance?

Question 304

Wed, 22 Oct 2025 20:55:11 GMT

If a PAAB opinion is requested for a specific, does a positive or negative opinion affect the outcome of a subsequent clearance review?

Question 305

Wed, 22 Oct 2025 20:55:09 GMT

For search engine marketing, our researcher has indicated the French speaking and English speaking Canada use different vocabulary when searching for our therapeutic disease sites or product web sites. We have traditionally had our PAAB approved Search Ads and keywords directly translated from English into French and then submitted the French for Approval.

Question 306

Wed, 22 Oct 2025 20:55:07 GMT

Are we able to re-purpose the content for one previously-approved medium (i.e. a poster) into a completely different medium (i.e. a magazine ad) without having the re-submit? Some items might be re-arranged to fit the new sizing.

Question 307

Wed, 22 Oct 2025 20:55:05 GMT

With more 'digital detailing' from reps to physicians using iPads and tablets, many software platforms offer the ability to re-order slides in a presentation. As PAAB approves these materials do they approve them in the order reviewed only, or as individual slides / videos etc that can be re-ordered by a drug company without further approval?

Question 308

Wed, 22 Oct 2025 20:55:03 GMT

HI there, Could you please elaborate on the exempt nature of personal correspondence (i.e. email between HCP and rep)? Under what conditions does that correspondence require PAAB review?

Question 309

Wed, 22 Oct 2025 20:55:02 GMT

Is the definition of "TMA" equivalent to or broader than the Product monograph? Are in-vitro studies on the MOA of a drug or drug components submitted to and reviewed by Health Canada as part of the NDS acceptable for use as supporting reference to non-clinical claims in promotion materials (as data on file) even if the published reference is not in the actual bibliography of references in the PM?

Question 310

Wed, 22 Oct 2025 20:55:00 GMT

Can a third-party disease awareness pamphlet (e.g. sun safety, skin cancer awareness) be displayed at a product booth that also has branded product material attended by a sales representative?

Question 311

Wed, 22 Oct 2025 20:54:58 GMT

If a disease state can cause mortality, but products in that class are not indicated to improve survival/ reduce mortality (they are indicated to treat the disease), can mortality be discussed in a disease context if the same piece also discusses therapy options (editorial piece), or in the case of a branded piece a specific product? Would their be a need to completely separate the discussion of mortality in a disease-only piece that would have to be discussed in a separate call from any branded messing or discussion of therapy?

Question 312

Wed, 22 Oct 2025 20:54:56 GMT

What are the steps to review and approved a website? Does the content of the site may be revised first as independent, indicating the titles subtitles, main menu, submenu, boutons, etc..? And then once approved texts, we submit the entire site with images of each page and approuved content. Or should we submit from the first revision the entire website as one ASP needed to be revised with images of the design which will present content that not approuved?

Question 313

Wed, 22 Oct 2025 20:54:54 GMT

Does an indication statement constitute a therapeutic benefit/claim or efficacy statement in and of itself? If so, can you confirm that any APS with the indication statement on it would require highest level fair balance?

Question 314

Wed, 22 Oct 2025 20:54:52 GMT

Hi Patrick. I would like to know if you would consider this tag line "Because every day is special" a claim that would require to be supported by data (our medication increases overall survival). Thanks alot for your answer :)

Question 315

Wed, 22 Oct 2025 20:54:50 GMT

hello, in today's world, many interactions between industry and HCP'S are electronic. Often, a client will ask a questions via email to their representative. Any specific regulations about representative having "email conversations" with their clients?

Question 316

Wed, 22 Oct 2025 20:54:48 GMT

What are the limitations in terms of advertising for OTC pharmaceutical brands with a DIN?

Question 317

Wed, 22 Oct 2025 20:54:47 GMT

There seem to be some inconsistencies within the answers provided in this forum. In Question 313, PAAB replied that the indication does not constitute a 'claim' while in Question 303, PAAB stated that the indication is indeed a 'claim'. Could you please clarify your position. I'd argue that the indication is a claim as it refers to a therapeutic/ clinical effect.

Question 318

Wed, 22 Oct 2025 20:54:45 GMT

HI, will the new market created by HC under the MMPR require the Licensed Producers to work with the PAAB?

Question 319

Wed, 22 Oct 2025 20:54:43 GMT

I am confused on how Section 6.6vii is different from Consumer Brochures in "The distinction between advertising and other activities". The only differences I can think of is audience (patient vs. consumer), branding (branded vs. unbranded) and treatment discussion (no mention of treatment vs. objective discussion of all available treatments). Am I on the right track? Thanks!

Question 321

Wed, 22 Oct 2025 20:54:41 GMT

A patient information brochure will NOT mention the product but will bear the name of the manufacturer. It will be distributed by the rep to the requesting health care professionals. Will this still need PAAB review?

Question 322

Wed, 22 Oct 2025 20:54:39 GMT

Dear PAAB, If data or statements exist in the product monograph but has no statistics associated with it, is it approvable?

Question 323

Wed, 22 Oct 2025 20:54:37 GMT

Would categorizing a video as "Unlisted" within YouTube be adequate access control for HCP branded or unbranded content provided the link to the video were only given to people who were known to possess proper credentials?

Question 324

Wed, 22 Oct 2025 20:54:35 GMT

Dear PAAB, what difference does it make when we combine data from duifferent sections of the TMA (PM). i.e can we put data from the clinical trial section and the adverse event section together since the adverse events are from the clinical trials?

Question 325

Wed, 22 Oct 2025 20:54:33 GMT

Good morning, regarding a patient care program related to a specific drug that pharmacists can participate in to support their patients, does a document communicating: what the program is about, including that it's for patients diagnosed with illness A and prescribed Drug A (no claims or any other info about the drug) how the program benefits the patient how to enroll Does qualify as a document requiring PAAB approval? Thank you very much in advance.

Question 326

Wed, 22 Oct 2025 20:54:31 GMT

Can we create a comparative timeline of 2 products (1 ours and 1 a competitor) from the same therapeutic category and who have some of the same indications? The timelines would only show indications, which ones each product has and when they were received. Thank you.

Question 327

Wed, 22 Oct 2025 20:54:29 GMT

Hi There, Our client has just received NOC to a new product. They do not have a large Sales Force and therefore is not looking to develop comprehensive materials. They would like to take their approved Product Monograph and highlight key messages within it - not changing any copy/content - but just simple draw attention to specific sections, such as patient groups, efficacy and adverse events. We would submit the highlighted PM through PAAB for approval - but before we go into development I just wanted to confirm this would be something PAAB would allow.

Question 328

Wed, 22 Oct 2025 20:54:28 GMT

Our client would like to have a website about the features of its medical device (a self-injection device). The website would not mention the name of the drug that goes in the device but it would mention the therapeutic area. The intended audience is patients who would be directed to the website by their HCPs. Am I correct that this website requires PAAB pre-clearance? What if the website had content only about the features of the medical device and did not mention the drug product in any way and did not mention the therapeutic area, would it then be exempt from review since the PAAB doesn't review medical devices? Or would it require pre-clearance because it is sponsored content that patients are being directed to? Thanks in advance for your response.

Question 329

Wed, 22 Oct 2025 20:54:26 GMT

Once a patient website for a medication is PAAB approved, do the footnotes and references need to appear in the copy of the live site?

Question 330

Wed, 22 Oct 2025 20:54:24 GMT

Does "coming soon" on an approved product require PAAB approval?

Question 331

Wed, 22 Oct 2025 20:54:22 GMT

What are the rules/regulations of non-pharmacological aspects on branded pieces. For example are questions about symptoms acceptable?

Question 332

Wed, 22 Oct 2025 20:54:20 GMT

Would the discussion of the bioequivalence of a particular product be considered to be a non-pharmacologic claim? If the piece included bioequivalence data (and no other claims) would the lowest level of fair balance suffice?

Question 333

Wed, 22 Oct 2025 20:54:18 GMT

I was wondering where I could find information on pharma companies referring a patient to a specialist on their website or a third party website.

Question 334

Wed, 22 Oct 2025 20:54:16 GMT

A product is not yet approved in Canada but approved in the US and Europe. In an international conference held in Canada, can we invite Canadian healthcare professionals to attend an company-sponsored talk within the conference auspices...and the presentation includes the unapproved product?

Question 335

Wed, 22 Oct 2025 20:54:14 GMT

I'm creating a document for a drug that pharmacists will hand to the patient along with their filled prescription for this drug at the drug store. This document will include, "what you should know about the drug", "different medical conditions the drug treats" as well as "how the drug works." Will I need to add "Important Safety Information" to this document and if so what aspects will I need to include in this?

Question 336

Wed, 22 Oct 2025 20:54:12 GMT

The data appearing in a product monograph is based on a pivotal trial. The same study also discusses 'off-label' endpoints. Can reps distribute the reprint of the study to support data that is in the PM?

Question 337

Wed, 22 Oct 2025 20:54:11 GMT

When we have an update on our product monograph, do we need to revise the piece related to the product and resubmit to PAAB right away or we can wait for the PAAB renewal date?

Question 338

Wed, 22 Oct 2025 20:54:09 GMT

Can you advise if published, qualitative studies are acceptable for patient preference claims under the new Code?

Question 339

Wed, 22 Oct 2025 20:54:07 GMT

If we believe content is PAAB exempt, due to new guidelines, do you need to review the content and how it will be used to determine PAAB exemption and then send us a letter stating exemption or not?

Question 340

Wed, 22 Oct 2025 20:54:05 GMT

Can a fractional advertising insert (on light cardboard stock) be - inserted - loose with a medical journal that is polybagged - or glued on the f.p. size : 2 1/2"x 10" or 4" x 10" printed on both sides insert to be glued on the f.p.

Question 341

Wed, 22 Oct 2025 20:54:03 GMT

If 2 Files are received that have conflicting Reviewer comments (one favourable, one unfavourable), what is the recommended process for progressing both Files in terms of consistency Should we progress the favourable review, then cite that approval for the unfavourable review? Bringing the inconsistency to the attention of the Reviewers tends to lean towards a conservative outcome from the PAAB.

Question 342

Wed, 22 Oct 2025 20:54:01 GMT

In the development of booth promotional materials intended to reprise indications, contraindications, warning and precautions which are part of the Product Monograph, are there any restrictions on how these sections can be excerpted. Is is permissible to exclude text from the indications section, for example?

Question 343

Wed, 22 Oct 2025 20:53:59 GMT

We are planning market research with healthcare professionals to identify new marketing insights and opportunities. The research will be in the form of informal interviews/discussions with HCPs. Does the PAAB need to be involved with the research planning? This would be organized and conducted by an agency and the sponsoring client would only receive anonymous insights and findings. Does the answer depend on any of the following? If interview questions are provided to the HCP in advance vs. an impromptu discussion? If the interview/discussion covers specific products vs. only diseases.

Question 344

Wed, 22 Oct 2025 20:53:58 GMT

Hi Patrick, Lately PAAB has been requesting that the indication for a product be placed on the front page of every piece. If we are not making any clinical claims on a front page of a piece, why can we not include the indication on the second page of a piece? Your PAAB code clearly says: 2.10.2 - PAAB code, The TMA content, "Drug X is indicated for" (or equivalent) must be presented verbatim at least once within the advertising message of the APS. Nowhere does it say it has to be on the front page.....thanks!

Question 345

Wed, 22 Oct 2025 20:53:56 GMT

In light of the new Fair Balance requirements (high level), are we required to include all the laboratory monitoring as part of the warnings and precautions section? It seems like a lot of info given that they are monitoring guidance but not warnings per se (e.g. monitor leucocytes very 4 weeks ...). Please advise.

Question 346

Wed, 22 Oct 2025 20:53:54 GMT

Hello. Could you please clarify if the indication statement is considered a claim?

Question 347

Wed, 22 Oct 2025 20:53:52 GMT

Is the message "Now Approved" acceptable in APS? It seemed that at one time, this was discouraged due to the perception of Health Canada endorsement

Question 348

Wed, 22 Oct 2025 20:53:50 GMT

We have an app that has already received PAAB approval last year. The client will receive NOC early July for a new indication and the app will have to be updated to include this new data. How much in advance can we submit the document pre the NOC for the new indication and what documents would we be required to submit ie annotated product monograph.

Question 349

Wed, 22 Oct 2025 20:53:49 GMT

Removed 07/2018

Question 350

Wed, 22 Oct 2025 20:53:47 GMT

Is sponsorship of an accredited CME event considered marketing on the part of a pharmaceutical company? Can the CME provider include therapeutics that are not (as yet?) approved for use in Canada for a specific indication? The product has been approved in Europe and the USA for that same indication. There is no off-label issue. Only the scientific evidence will be presented concerning the drug.

Question 351

Wed, 22 Oct 2025 20:53:45 GMT

Hi PAAB, could you please advise what is required in terms of balancing copy for NHP products?

Question 352

Wed, 22 Oct 2025 20:53:42 GMT

Can you please explain the rationale behind not being "promotional" in branded patient-directed material? Product claims would seem to promote adherence, and therefore be beneficial to the patient.

Question 353

Wed, 22 Oct 2025 20:53:41 GMT

Is the use of social media to discuss patient experience / present factual research / raise awareness of a particular medical condition allowed - without mention of the actual treatment, but with the name of a company mentioned?

Question 354

Wed, 22 Oct 2025 20:53:39 GMT

What is the process to follow if I disagree with a reviewer's ruling and want to challenge it further?

Question 355

Wed, 22 Oct 2025 20:53:37 GMT

How does one guage whether a disease APS has no link to healthcare advertising? (re 6.6vii)

Question 356

Wed, 22 Oct 2025 20:53:35 GMT

Could you please clarify the response to Question 232, as it seems to imply that there is no such thing as a true "unbranded" piece. The nature of the Rep-HCP interaction is such that unbranded and branded discussions frequently take place in the same call. It was our understanding that as long as there is a clear transition/distinguishing between unbranded and branded content, that pieces are reviewed separately without assuming linkage.

Question 357

Wed, 22 Oct 2025 20:53:33 GMT

We have a consumer website for our OTC product that is ASC-approved. Can we include the link to our consumer website on a HCP marketing material, which will be submitted to PAAB, if the website itself was not PAAB-reviewed?

Question 358

Wed, 22 Oct 2025 20:53:32 GMT

Can you please advise what is required to substantiate a market share claim for a prescription product (i.e. will IMS data suffice)? How long must a market leadership position be maintained in order to make such a claim? How long is the claim valid?

Question 359

Wed, 22 Oct 2025 20:53:30 GMT

Referring to PAAB Code 6.5.4 - The sponsor may link to corporate global sites only by linking to the global site home page. The sponsor should not link to the global site product pages or sections. Please confirm if we can link to the homepage of our Corporate website for Canada (.ca) or do we have to link to the global site (.com)? Lastly, our source for product monographs is our local corporate website. Please confirm that we can link directly to our product monograph from our promotional websites for quality control.

Question 360

Wed, 22 Oct 2025 20:53:28 GMT

A client wishes to produce some material that will be strictly used by their medical team (i.e. MSLs, Med Affairs, Medical Education Specialists). It will contain product efficacy outcomes that will be balanced with safety and AEs, and thus will be strictly used in a non-promotional manner. The piece itself will meet the requirements of Health Canada as NOT being advertising, but they wish to have a PAAB exemption letter. QUESTION: Looking at section 6.6(iv) of the code, one of the exemption scenarios involves: Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in in any way. Could you clarify what 'therapeutic message' entails? Would efficacy charts be considered a therapeutic message?

Question 361

Wed, 22 Oct 2025 20:53:26 GMT

Has there been any code infraction of late that you can share to us? And what does PAAB do about it?

Question 362

Wed, 22 Oct 2025 20:53:24 GMT

Are poster presentations in medical conferences acceptable as a reference for promotional materials?

Question 363

Wed, 22 Oct 2025 20:53:22 GMT

Can you please remind me of the rules related to printing and distributing your product monograph? I believe you can reprint it exactly as is and to do so would be PAAB exempt. However, if you add a cover with your brand identity, your logo and indication statement(s), yet no claims, is that now classified as a "commercial" PM and thus requires PAAB review? Or is it only if you make a claim on a branded front cover? TIA

Question 364

Wed, 22 Oct 2025 20:53:20 GMT

Hello, Can text from Part III/Consumer Information of a PM be used as a reference within and HCP directed piece? For example, if we were to define patient types that a product is indicated for and use the language defining such patients from Part III, would this be acceptable in HCP directed materials?

Question 365

Wed, 22 Oct 2025 20:53:19 GMT

Are reports published from unaccredited CME events (ie. symposia) subject to PAAB approval?

Question 366

Wed, 22 Oct 2025 20:53:17 GMT

If the product is in a therapeutic area where we cannot use IMS data because of market definitions, can we use patient chart study or any other form of study to show our performance in the market. Are there specific guidelines on sample or methodology?

Question 367

Wed, 22 Oct 2025 20:53:15 GMT

Where in the code does it stipulate the requirements for communication between Health Care Professional to Health Care Professional?

Question 368

Wed, 22 Oct 2025 20:53:13 GMT

We have an existing product with a new indication. We would like to announce the 'new' indication like "Now indicated in...". What level of fair balance would be required?

Question 369

Wed, 22 Oct 2025 20:53:11 GMT

Hi Patrick. Accreditation for a CHE program has expired and the company wants to turn it into an OLA. The role of the reps is restricted to logistics only and the content is all on label. The program has been developed by HCPs and is presented by trained HCP speakers. Does the OLA content need to be reviewed by PAAB? Thank you.

Question 370

Wed, 22 Oct 2025 20:53:09 GMT

We have a question related to the placement of formulary messaging on sample boxes. Is it acceptable to place a formulary sticker on a sample box? If so what kind of approvals would be required to permit this action?

Question 371

Wed, 22 Oct 2025 20:53:08 GMT

What are the rules regarding having Unbranded DTC materials aesthetically similar to Unbranded HCP materials? Can they share graphic elements, fonts, images?

Question 372

Wed, 22 Oct 2025 20:53:06 GMT

When advertising to the HCP target via appropriately gated sites, what are the restrictions around static content? Can a drug ad be placed within relevant content? or target the content on the site specifically?

Question 373

Wed, 22 Oct 2025 20:53:04 GMT

What is the guideline for a Med Info booth included within the footprint of a commercial booth at conferences?

Question 374

Wed, 22 Oct 2025 20:53:02 GMT

Do slide presentations for industry-sponsored satellites at an international congress held in Canada require PAAB approval? Are there any circumstances in which unlicensed products can be discussed in such a forum?

Question 376

Wed, 22 Oct 2025 20:53:00 GMT

We have a PAAB-approved fax blast for pharmacists. Our marketing team wants to remove the product codes and prices and send the piece to physicians. This is the only change…would the revised fax blast need to go through PAAB-review? If it does not, is it ok to keep the PAAB logo on the piece?

Question 377

Wed, 22 Oct 2025 20:52:59 GMT

I need to do a slide presentation to clinicians. I represent the medical dept. I will be talking on our products and some on competitors. What am I allowed to speak on. Do I need to also send it to PAAB for approval?

Question 378

Wed, 22 Oct 2025 20:52:57 GMT

Creating a website which makes reference on use of botox and latisse. Both are prescribed drugs. Does this create an issue with Health Canada guidelines? We are not advertising the products but reference them as to what they can do for patients as well as the possible side effects.

Question 379

Wed, 22 Oct 2025 20:52:55 GMT

I just want to know the complaints process for PAAB files.

Question 380

Wed, 22 Oct 2025 20:52:53 GMT

Are we allowed to post full product monographs on our corporate website, or do they have be behind a HCP-gate?

Question 381

Wed, 22 Oct 2025 20:52:52 GMT

Hi there, Is the full article needed for the references or is the abstract okay if the content of the reference is there. Thank you, Anne

Question 382

Wed, 22 Oct 2025 20:52:50 GMT

I've had the benefit of reading #84. Is it fair to say that a Rep for Product X who during a call receives an unsolicited request from a physician for a reprint of a journal article, in which the manufacturer had no influence over content, and which contains only "on-label" information, and further provided the Rep does not include any summary of the article, but does discuss the approved benefits of Product X during the call, would not be considered advertising?

Question 383

Wed, 22 Oct 2025 20:52:47 GMT

We have 2 questions regarding inclusion of treatment guideline statements that address drug place in therapy (our product is sited by non-proprietary name) in HCP-directed APS: 1. a) Can treatment guideline statements be included anywhere among product claims? b) Similarly, can treatment guidelines be included on the other side (back or front) of a page containing product claims? 2) Can treatment guidelines be included on the other side of a page containing the main sections of the Product Monograph of product sited in the guidelines (Dosage, Indications, Warnings and Precautions, Contraindications and Adverse reactions)?

Question 384

Wed, 22 Oct 2025 20:52:45 GMT

What type of references are allowed in unbranded materials? I am interested in using studies which are based on patient surveys/questionnaires as well as some review papers (neither of which have a focus on the company's branded product). Would these type of references be allowed or are strictly limited to the same rules as branded communications? Thanks.

Question 385

Wed, 22 Oct 2025 20:52:43 GMT

Our client would like to produce a Canadian consensus statement in a disease area where there are currently no relevant guidelines. The publication would be peer-reviewed and cover all therapeutic options; we would ensure that any discussion of the sponsor's product was on-label. The intent would then be to distribute reprints through the sales force, and possibly also create an unbranded APS highlighting the availability of the consensus statement (no emphasis on a particular drug). Can you give us any guidance on how we should set up the consensus process and paper to be acceptable for these uses? Assuming the publication is peer-reviewed, would the fact that it has a single sponsor be an issue? Is endorsement by a medical association required or just recommended? Thanks in advance.

Question 386

Wed, 22 Oct 2025 20:52:41 GMT

I am developing a gated HCP website that requires the HCP to enter his/her license number to gain access to the site. Do you have any recommendation as the where to purchase a list of valid license numbers? Thank you.

Question 387

Wed, 22 Oct 2025 20:52:39 GMT

May we: Report the results of a patient satisfaction study to doctors?Ask doctors' opinions of key results from of that study?Then report back to all doctors a summary of responding doctors' aggregate opinions?

Question 388

Wed, 22 Oct 2025 20:52:38 GMT

I am a journalist doing a story on what advertising and or perqs are allowed to be given to doctors and medical professionals to use/prescribe a drug. What regulations are in place governing what is aimed at the medical professional?

Question 389

Wed, 22 Oct 2025 20:52:36 GMT

I would appreciate clarification of the Explanatory Note for 6.6 that says "Now on provincial formulary" (or equivalent). Does "or equivalent" allow you to mention a new strength and still be exempt? (e.g. The product is already on formulary but the product came out with an additional strength that was just added to the formulary and it is that new strength of Product X that is being announced as "Now on Provincial Formulary". Thank you!

Question 390

Wed, 22 Oct 2025 20:52:34 GMT

Do STI cards (cards that patients use to obtain medications for free or as a copay) come under PAAB or is this another industry organization that handles how these are used.

Question 391

Wed, 22 Oct 2025 20:52:32 GMT

Are notes to HCPs allowed to be attached to PAAB material or approved studies. If not, where is this referenced in the code.

Question 392

Wed, 22 Oct 2025 20:52:30 GMT

Would a corporate message similar to "Company X is committed to research in prostate cancer" be PAAB exempt?

Question 393

Wed, 22 Oct 2025 20:52:28 GMT

I am curious to know how/why the product ColdFX can make DTC claims such as 'clinically proven' and '#1 doctor recommended'. Would this not fall under the NHP regulations of PAAB?

Question 394

Wed, 22 Oct 2025 20:52:27 GMT

If a pharma company is developing a brochure that includes general information about clinical research to better educate patients who might be considering participation in a clinical trial, is PAAB (or another regulatory body) required to review and approve the brochure? Please note that this resource would not be developed for use during a specific trial; it is strictly for general patient education purposes.

Question 395

Wed, 22 Oct 2025 20:52:25 GMT

I am interested in PAAB training. How can I achieve this training?

Question 396

Wed, 22 Oct 2025 20:52:23 GMT

Does PAAB let us place information in detail aids that is in a reference found in a PM but not in the PM text itself?

Question 397

Wed, 22 Oct 2025 20:52:21 GMT

If you are creating a Pt Booklet based on Part III of the Product Monograph, can you also include a patient-friendly description of the primary efficacy outcome? If so, how about primary and secondary efficacy outcomes?

Question 398

Wed, 22 Oct 2025 20:52:19 GMT

In the current consultation by Health Canada on the Guidance Document: Product Monograph Release Part I: Health Professional Information and Part II: Scientific Information, Health Canada proposes to remove references, as per the response to question 309 , what impact would removal of references have on the utilization of the study by companies if not listed in the PM?

Question 399

Wed, 22 Oct 2025 20:52:17 GMT

We have an HCP-gated educational website/app containing endorsed medical education. We would like to post a program comprised of KOL-presented patient cases containing a video segment featuring one of that KOL's patients. What is the patient allowed to speak about on the video (e.g. their quality of life post-therapy...)?

Question 400

Wed, 22 Oct 2025 20:52:16 GMT

Are promotional materials for class II medical devices required to go through PAAB clearance?

Question 401

Wed, 22 Oct 2025 20:52:14 GMT

Is there a PAAB mandate anywhere that states that the pharmaceutical companies corporate logo has to appear on all PAAB reviewed and approved APS materials? We have a situation there are high-priority approved APS materials requiring printing; however the corporate branding is changing and won’t be fully established for some time.

Question 402

Wed, 22 Oct 2025 20:52:12 GMT

Hi, I am looking for a ruling on the following scenario. If a sales rep is using a PAAB approved, Un-branded, Disease state promotional piece to engage an HCP in a non-product related discussion. If, during that discussion, the physician asks that representative a product specific question, i.e. "What is the clinical data for Product "X" in the disease state we are discussing?”. Is the rep allowed to answer the question and switch to a product based discussion that incorporates PAAB approved promotional pieces? What specifically can the rep do in a situation like this where the use of PAAB approved messaging and promotional pieces are strictly reactive?

Question 403

Wed, 22 Oct 2025 20:52:10 GMT

Are the presentations/slides of our medical directors subject to PAAB review? Under what circumstances can our medical director or medical scientific liaisons provide learning programs? Must it be a solicited request for education?

Question 404

Wed, 22 Oct 2025 20:52:08 GMT

Hi Patrick, I am doing a slide kit for the reps based on our PM. In the PM it mentions a study with our drug against a non-approved drug, so I can use this info in my slide. New studies have come out on our drug vs the non-approved drug would I be able to use this new data in my slide deck for the reps.

Question 406

Wed, 22 Oct 2025 20:52:07 GMT

In an unbranded context, is it possible to use a guideline treatment algorithm that recommends drugs that are off label for the condition it pertains?

Question 407

Wed, 22 Oct 2025 20:52:05 GMT

Does PAAB review and approve both the copy and the layout before they issue a PAAB approval reference number? Or is it only the copy which is reviewed and approved? Thank you.

Question 408

Wed, 22 Oct 2025 20:52:03 GMT

Would an objective slide deck prepared and approved by the medical department of the company for the sole use by MSLs in their 1:1 interactions with HCPs be considered PAAB exempt?

Question 410

Wed, 22 Oct 2025 20:52:01 GMT

If our company has sponsored a newsletter for a healthcare professional group (which official represents their professional specialty) that discusses updates to their independent website (password protected for members and sponsored by us as well) and the sales force is going to distribute this newsletter proactively, does it fall under PAAB's scope for review due to frequency of distribution/availability and sponsorship combination. The website touches on best practices for a disease area including treatment so the newsletter will touch on updates to any of this and do mention our product. The company does not have any ability to alter content if there is a comment from PAAB. We would appreciate clarification as we were still not clear after working through the decision tool on the PAAB website (which is awesome by the way). We are running into similar issues with a disease and treatment video for patients produced by the same group (sponsored by us) which the sales force would also like to distribute broadly healthcare professionals as a DVD and show on their i-pad. (Again, no ability to change content). The two scenarios (newsletter and video) have similar components. Thank you so much for your guidance on this.

Question 411

Wed, 22 Oct 2025 20:51:59 GMT

Is it within regulation for a pharmaceutical company to disseminate information through patient groups (as opposed to through a health care provider).

Question 412

Wed, 22 Oct 2025 20:51:58 GMT

We have a slide deck that is being presented to HCPs by members of our medical team. This deck is PAAB approved. We have a few questions. Can we record the session and place it on our HCP gated portal for other HCP's to benefit from? Does the recording require PAAB approval? In the post-production of the video, can we add chapters to the video so if physicians wanted to watch the video in segments, they can? Thank you.

Question 413

Wed, 22 Oct 2025 20:51:56 GMT

If the URL for a PAAB approved HCP portal (which contains gated product information - PAAB approved) is included on the back of a sales representative’s business card, does the business card now require PAAB approval?

Question 414

Wed, 22 Oct 2025 20:51:54 GMT

Hello PAAB, The approval on one of our APS's is going to expire and we would like to continue using this APS. What is the process to renew the PAAB approval? Do we need to resubmit everything for review even if nothing in the APS has changed? Thanks

Question 415

Wed, 22 Oct 2025 20:51:52 GMT

Does PAAB have any specific regulations around infographics? It outlines study results.

Question 416

Wed, 22 Oct 2025 20:51:50 GMT

We are creating a website for HCPs using Responsive Web Design, in which one set of content (text, images etc.) will automatically be populated into different layout placements based on the size and configuration of the screen on an HCPs device (table, smartphone, laptop etc.). We would like to submit only 2 breakpoints for review (desktop & smartphone), because the tablet version will either follow the desktop size/dimensions - or the mobile, depending on the orientation of the screen (vertical or landscape). Would providing layouts, copy and wireframes for the 2 breakpoints satisfy PAAB submission requirements? Will you also require screenshots of the tablet version? Will the different breakpoints require separate submissions? Or will they be reviewed separately but as a series fee?

Question 417

Wed, 22 Oct 2025 20:51:49 GMT

Hi Patrick, Can a company position its brand (from both a creative and messaging standpoint) on secondary outcomes in its PM? If not, then what code number does this contravene?

Question 418

Wed, 22 Oct 2025 20:51:47 GMT

Explanatory note 4.4.3 states the following: "Where mandated by the consumer advertising regulations [s6.5.6], the web link destination must either be gated or de-indexed from search engines. If the site is gated, the URL or electronic link promoted in the APS must bypass the gate such that password entry is not required to access these disclosure documents. The URL and electronic link must therefore be promoted only to HCPs." Could you please explain the criteria a website must meet to be considered "de-indexed"?

Question 419

Wed, 22 Oct 2025 20:51:45 GMT

Can a reprint be distributed by the Sales force where the use is within the approved indication, yet the reprint discusses endpoints that are not discussed within the Approved Product Monograph?

Question 420

Wed, 22 Oct 2025 20:51:43 GMT

What are the requirements for display signs at a conference? The display sign contains pictures of drug products and contains general information about the product. Would fair balance need to be applied to this display? Are we required to include the indications on the display? This sign would only be used at conferences along with brochures which contain the indications and fair balance information.

Question 421

Wed, 22 Oct 2025 20:51:41 GMT

Can I pharmaceutical company support the development of an independent third-party publication covering the highlights of a conference in a therapeutic area where it does not yet have an approved product? The report and a summary slide presentation with the same content is developed by an independent faculty of medical experts, who have full control of the content, and coordinated by a third-party communication agency. The content is completely unbiased (less than 10% of the content is about trials on the company's future potential product), and there is no involvement of the company in the distribution of the content. The content is housed on a third-party independent website that is distributed by this third-party and/or to medical associations only. Does the site have to be gated? Does the content have to be PAAB-reviewed or accredited? Thank you in advance for your answer.

Question 422

Wed, 22 Oct 2025 20:51:39 GMT

Dear PAAB. The PAAB codes states that superlatives or special status cannot be used unless substantiation can be provided. What is the substantiation you are looking for? Is the monograph a source that would suffice?

Question 423

Wed, 22 Oct 2025 20:51:38 GMT

Definitions Section 1.8 of the PAAB code states: Use of the word 'new' or statements implying "new" in advertising should be restricted to 1 year after initial marketing. Can you please clarify what is meant by "initial marketing"? Is this the NOC date or when "marketing" activity is initiated etc.?

Question 424

Wed, 22 Oct 2025 20:51:36 GMT

Hello! Would it be possible to know if there is a one year time limit for us to have an HCP education piece approved by PAAB after the launch of a new indication? Thank you!

Question 425

Wed, 22 Oct 2025 20:51:34 GMT

Can a pharmaceutical company publish the results of a clinical study that was supported by a scientific grant. Would this have to be identified as advertorial?

Question 426

Wed, 22 Oct 2025 20:51:32 GMT

Can I post a branded online banner on a website such as Canoe santé that already provides information on a prescription drug (i.e. there is information on the drug and the disease it treats).

Question 427

Wed, 22 Oct 2025 20:51:30 GMT

Recently we've seen an APS that have been submitted where p-values were requested for safety data, otherwise it would not be admissible as data. The problem is, virtually no clinical trials power their adverse events to generate p-values. When did this become a requirement?

Question 428

Wed, 22 Oct 2025 20:51:28 GMT

If I have an APS which is left behind, however only contains the name of the product with no other information (i.e., company name, price, quantity, indication etc.), do I need PAAB’s approval?

Question 429

Wed, 22 Oct 2025 20:51:27 GMT

Does an advertisement for an OTC product that will run in a medical journal require PAAB approval? The ad does include product claims, with references.

Question 430

Wed, 22 Oct 2025 20:51:25 GMT

One of the pivotal trials for an advertised brand has a reference comparator (RC) arm (i.e., the trial has statistical analysis for the advertised brand vs placebo and the RC vs placebo, but no statistical analysis for the advertised brand vs RC). The Product Monograph mentions the RC as part of the design, but no RC data is included in the PM. Can the data for the RC vs placebo be shown in an APS?

Question 431

Wed, 22 Oct 2025 20:51:23 GMT

Hello, in case of branded APS, are references older than 10 years not accepted? Thanks!

Question 432

Wed, 22 Oct 2025 20:51:21 GMT

With reference to PAAB Code section 6.6 (vii), what is the difference between class and category? Would an unbranded patient piece that mentions "treatment" without any specifics be exempt from PAAB preclearance? For further context, the disease state that the piece focuses on can be managed in various ways, including watch and wait.

Question 433

Wed, 22 Oct 2025 20:51:19 GMT

Are medical devices specifically excluded somewhere in the PAAB Code of Advertising Acceptance book?

Question 434

Wed, 22 Oct 2025 20:51:18 GMT

For traditional online banner ads, how can one be expected to fit the verbatim indication on the first 'frame' also containing a claim? Traditional banners are only a few pixels in size, which seems to prohibit effective advertising for products with larger indications.

Question 435

Wed, 22 Oct 2025 20:51:16 GMT

We are developing an unbranded APS (Journal Ad). This APS would contain statistics and data pertaining to disease state. This APS would be disseminated directly to HCPs via print publications and perhaps some e-publications. The call-to-action on the APS would lead HCPs to register for an accredited e-CME on the disease state. Will PAAB require that the accredited CME be submitted for review?

Question 436

Wed, 22 Oct 2025 20:51:14 GMT

Can a television spot that has run in the United States run in Canada if it has been stripped of all branding and promotional claims, and edited to meet the requirements of a help-seeking ad?

Question 437

Wed, 22 Oct 2025 20:51:12 GMT

Is it allowed to do "help seeking announcements" if you are the only prescription product with a specific indication. We would not reference treatments, just talk to your doctor about diagnosis. Thank you for your help.

Question 438

Wed, 22 Oct 2025 20:51:10 GMT

I would like to do a price per month comparison of a number of products. The official indications may vary slightly and some of the products would be OTC and some prescriptions. Is this possible and do you have any advice. Secondly what are acceptable pricing sources? Thank you.

Question 439

Wed, 22 Oct 2025 20:51:09 GMT

Upon reading the PAAB guidance it appears that we are able to put general disease information and general symptoms into a Patient booklet that is distributed to patients after they have been prescribed the drug. Is this the case?

Question 440

Wed, 22 Oct 2025 20:51:07 GMT

As a result of a recent PAAB approval I believe that a branded APS may contain corporate messages if - the messages are not contained on the same page as the branded material - this new page containing corporate messages does not contain any drug branding - this new page containing corporate messages appears after the fair balance My questions are: 1. would the same rules apply, with regard to corporate messages, to a branded drug manufacturing video? 2. If so, could corporate messages be included at the beginning of the video, before introduction of the product and its indication statement?

Question 441

Wed, 22 Oct 2025 20:51:05 GMT

There is a unique provincial situation in which the manufacturer has lowered the price of its drug to match the price of its generic substitute. Can we create an APS that speaks to this fact and claim that patients can continue to receive said drug "at no additional cost* compared to the generic version."? *Refers to the drug acquisition cost; dispensing fees not covered.

Question 442

Wed, 22 Oct 2025 20:51:03 GMT

Question 443

Wed, 22 Oct 2025 20:51:02 GMT

For DTCI campaigns, are we allowed to focus on a certain stage of the disease? (For example, mild).

Question 444

Wed, 22 Oct 2025 20:51:00 GMT

If patients have registered for a branded patient website (which has a gated landing page) and opted in to receive emails, can the emails direct them to a page behind the gate? Would this page need to be gated? Or, do they need to be directed to the gated landing page?

Question 445

Wed, 22 Oct 2025 20:50:58 GMT

Further to Question 177, does PAAB exemption also apply to Health Canada-approved patient materials distributed by an HCP in a risk management plan?

Question 446

Wed, 22 Oct 2025 20:50:56 GMT

Can you confirm whether Code sections 2.10.1 and 2.10.2 are mutually exclusive? For example, could an abbreviated indication appear with the first marketing claim in an APS, with the verbatim indication appearing elsewhere in the APS?

Question 447

Wed, 22 Oct 2025 20:50:54 GMT

For consumer surveys which are meant to gather information about current knowledge/attitudes on a certain medical condition and contains no medical information, does it need to be submitted to PAAB along with the rest of the DTCI campaign? We plan to use the survey results as a means to tailor content that addresses some of the knowledge gaps/attitude of consumers. Thank you kindly.

Question 448

Wed, 22 Oct 2025 20:50:53 GMT

If a copy deck was first developed in French, can we submit it for review in French, or would it need to be translated to English and the initial review performed on the English?

Question 449

Wed, 22 Oct 2025 20:50:51 GMT

Hello, I am an international Arab candidate. I have been working for GlaxoSmithKline since 2008 in the sales and marketing field. I have plenty of contribution in communication and marketing, as I am planning to study for an advertising diploma in Canada. What will be the percentage for me to find a job in the medical advertising field after graduation? Thanks for your support.

Question 450

Wed, 22 Oct 2025 20:50:49 GMT

Is it possible to attach patients' testimonials to a tool destined to inform patients on how to optimally use a medication they are already using?

Question 451

Wed, 22 Oct 2025 20:50:48 GMT

Dear PAAB. I understand pharmacokinetics is considered "non-clinical" information. Is "indication" and "dosing" considered non-clinical information? It would appear to me the condition in which a drug is studied and hence approved and also the dose at which safety and efficacy is determined is extremely clinically relevant and would be considered "clinical information". Thank you for your consideration.

Question 452

Wed, 22 Oct 2025 20:50:46 GMT

We are creating an unbranded teaching easel for physicians to use with patients. The easel is highly visual but does show some disease statistics and mentions classes of drugs/protocols, but not specific brands. Because this piece is never given to the patient, does it come under the same content rules as tools the patient would take home? We want to minimize clutter and just let the physician speak to the images and answer patient questions. For example: - For disease stats, does all of the information on how the stats were collected have to be on the piece? If so, can it just be put on the back of the page that the physician sees, but the patient does not? - In the section where drug classes/protocols are named, does safety information have to be included? If so, again, can this be placed on the physician-view side only? Thank you.

Question 453

Wed, 22 Oct 2025 20:50:44 GMT

We are creating a branded device for pharmacist’s physicians to use with patients. The easel is highly visual but does show some disease statistics and mentions classes of drugs/and social protocols, with specific brands of medication. Because this piece is never given to the patient, it comes under the same content rules as tools the patient would take home. Please let me know if you want the device.

Question 454

Wed, 22 Oct 2025 20:50:42 GMT

For an HCP-directed piece relating to a patient program, where brand name and indication are given in addition to the monitoring schedule from warnings & precautions, what level of balance would be required?

Question 455

Wed, 22 Oct 2025 20:50:40 GMT

What is the recommended mechanism to validate Healthcare Professional status (i.e. gating mechanism) for a website with potentially some consumer advertising content? Some websites ask for Canadian professional license number, but is it a requirement to verify this information (e.g. license number, name, etc.) once it's obtained? If so, with what database/organization?

Question 456

Wed, 22 Oct 2025 20:50:38 GMT

We have several questions regarding risk of linkage between disease/indication and another company's product (brand name or non-proprietary name) when purchasing keywords for Search Engine Marketing for a disease-support website and App (both are unbranded) for patients: a) Can we use a competitor's prescription product brand name as the keyword, when the brand name is not marketed in Canada? i. Same question - this time the non-proprietary name is the keyword? This question is to address situations in which the same medicinal ingredient is marketed in Canada but under a different brand name. b) Can we use a competitor's non-prescription product brand name as the keyword, when the brand name is not marketed in Canada? We understand linkage between product and indication in not an issue in this situation; we would like to know if it is still acceptable (morally/ethically). i. Same question - this time the non-proprietary name of the non-prescription product is the keyword? c) Can we use a competitor's prescription product brand name or non-proprietary name as the keyword, when the product is marketed in Canada? i. Can we use a competitor's non-prescription product brand name or non-proprietary name as the keyword, when the product is marketed in Canada? d) Are we required to submit the SEM campaign (keywords, Ad text, etc) for this disease-support website and App to PAAB or ASC for review? ASC has already reviewed and approved both the website and App.

Question 457

Wed, 22 Oct 2025 20:50:36 GMT

We have been asked to update a patient information booklet for people who have been prescribed the drug. The drug has two indications. Patients may have both conditions, but it's most likely that they have been prescribed the drug for only one of the conditions. Both indications are for adults only and both indications are described in the same Part 3 and use the same patient information booklet. Our drug is coming out with an adolescent indication for only one of the indications. We want to update the patient information booklet to include the adolescent indication. I think it should be fine to add the adolescent indication to the existing approved booklet as long as the adolescent info is in the same Part 3 from which the patient information booklet was developed. Are there any other considerations for putting the adolescent info in a separate booklet? There is not much new content to Part 3 except the age change. Thanks!

Question 458

Wed, 22 Oct 2025 20:50:34 GMT

What are PAAB's guidelines or restrictions (if any), regarding boosting posts or promoting a corporate (unbranded) social media page (including Twitter, Facebook, Instagram, LinkedIn)?

Question 459

Wed, 22 Oct 2025 20:50:33 GMT

I'm working in a branded patient-information brochure that includes disease information and dosing. All the content is consistent with part III of the TMA. Does this piece require fair balancing copy? If so, what information is required in the fair balance for patient pieces?

Question 460

Wed, 22 Oct 2025 20:50:31 GMT

Hi sir. What are the guidelines and regulations for advertising an OTC drug and please can you provide the links?

Question 461

Wed, 22 Oct 2025 20:50:29 GMT

Dear PAAB. Can information from Section I and II be used in patient information? Secondly, how does PAAB define something as "promotional" versus factual information for patient information? Thank you.

Question 462

Wed, 22 Oct 2025 20:50:27 GMT

Hi Patrick, We are planning a card that is for patients to carry with them, showing that they have been prescribed product X, which dose, physician contact info, etc (basically a wallet card). We are also preparing a stand for these cards that would sit in the physician's office. Each time they prescribe a patient product X, they grab a card from the stand and fill it out with the patient. The objective of the card is to instruct patients they need to show this card to other HCPs, to ensure these HCPs do not co-administer certain products with product X. Our question: can the card be submitted as patient-directed and the holder as physician-directed, as the holder will never leave the physician's office? The holder really is meant as instruction for the physician. Thank you.

Question 463

Wed, 22 Oct 2025 20:50:25 GMT

Is DTC advertising (i.e. patient support website, journal ads, and waiting room brochures) allowed for a schedule D biologic that is not used to treat or cure a schedule A disease?

Question 464

Wed, 22 Oct 2025 20:50:23 GMT

Can unbranded patient materials (covering disease state) have a look & feel/creative that is consistent with a DTC campaign?

Question 465

Wed, 22 Oct 2025 20:50:21 GMT

Is it permissible to present efficacy results from real patient cases (provided the cases are anonymous and align with the TMA)?

Question 466

Wed, 22 Oct 2025 20:50:19 GMT

What types of claims (if any) are acceptable in email subject lines directed to HCPs?

Question 467

Wed, 22 Oct 2025 20:50:17 GMT

To whom it may concern, I am looking for some clarification regarding the definition of a “therapeutic message” per section 6.6 (iv) of the code regarding exemptions: “Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in any way.” Specifically, we would like to send a fax to pharmacists announcing the approval/availability of a new medication along with details required for their ordering systems (i.e. product code, D.I.N., etc.) Can we simply say the name + the type of medication + disease state? For example: Product X, an SSRI for treating depression, is now available in Canada? This doesn’t link to HOW X treats depression or what an SSRI does...

Question 468

Wed, 22 Oct 2025 20:50:16 GMT

Hi Patrick, my question is regarding the use of an economic impact study and doing a slide deck around it. Is this not PAAB exempt given that this is not about clinicals but cost savings?

Question 469

Wed, 22 Oct 2025 20:50:14 GMT

Dear PAAB. Is it acceptable in branded APS to illustrate the patient journey using data from authoritative sources? For example, the patient has suffered for years and has tried a number of treatments before seeking medical advice. Thank you.

Question 470

Wed, 22 Oct 2025 20:50:12 GMT

Can a Patient Support Program be promoted to consumers? If so, would it be possible to mention features of the support program and link them to the company and the condition(s), with no mention of the products supported by the program?

Question 471

Wed, 22 Oct 2025 20:50:10 GMT

Can branded patient brochures have the same visuals as branded physician brochures?

Question 472

Wed, 22 Oct 2025 20:50:08 GMT

Can an ASC approved piece be used by pharma with an HCP if it is not PAAB approved? Can it be used in the HCP office via TV screen?

Question 473

Wed, 22 Oct 2025 20:50:07 GMT

Dear Patrick, I have a question regarding references that can be used in unbranded pieces in the category of cold and flu. As you know, the active ingredients in many cough, cold & flu products have long since become generic and in fact are used across a number of different products... I was wondering if experimental studies (e.g., in vitro/cell culture/ELISA), which do not use any brand specific sources of the molecule (i.e., generic), could be used in unbranded pieces to educate HCPs on the properties of the molecule (with any necessary caveats that clinical significance cannot be determined)? Thanks!

Question 474

Wed, 22 Oct 2025 20:50:05 GMT

Dear PAAB. Can sales reps distribute disease information directly to patients?

Question 475

Wed, 22 Oct 2025 20:50:03 GMT

Can you describe the patient condition, consistent with the indication in your promotional material? As an example, the patient has suffered in silence many years before seeing the doctor, tried other treatments and is now seeking help. This example would be supported by authoritative sources. If not an option in promotional APS would it be possible in unbranded APS. Thank you.

Question 476

Wed, 22 Oct 2025 20:50:01 GMT

If an APS only includes a claim of "New Drug X" or "Introducing Drug X", is this considered exempt from PAAB review? In this instance, only the name, price and DIN of the drug would be included.

Question 477

Wed, 22 Oct 2025 20:50:00 GMT

Is it possible to provide give-aways to patients already enrolled in patient support programs? The intention is for the item to be inexpensive and provided by the HCP. Thank you.

Question 478

Wed, 22 Oct 2025 20:49:58 GMT

Is it a requirement to include the wording 'For illustrative purposes only' when using videos that depict mode of action, simulate clinical scenarios or pathophysiological pathways?

Question 479

Wed, 22 Oct 2025 20:49:56 GMT

According to section 7.4, it sounds like Canadian corporate websites need to be reviewed by PAAB. However, I have not come across any that have the PAAB logo. Can you please clarify? From a previous Q&A it sounds like corporate websites have to be written with consumer regulations in mind too since they are publicly accessible. I guess that means we cannot have a write up on the therapeutic areas on the corporate website because that would be linking the therapeutic area to the product, because the product info would be found in the Product Monographs that are linked to the site. Can you please clarify this for me? Thank you!

Question 480

Wed, 22 Oct 2025 20:49:54 GMT

Is it possible to link a site with CME content from a gated, branded website? If so, is it possible to identify the tab as leading to CME content? Would it be possible to link to a CME-containing site using an interstitial page/disclaimer between this site and a branded website?

Question 481

Wed, 22 Oct 2025 20:49:52 GMT

Is it possible to refer to CME content on a web site in an unbranded email to HCPs?

Question 482

Wed, 22 Oct 2025 20:49:50 GMT

Is it acceptable to use Data on File such as a PSUR to support non-clinical statements such as patient exposure? If so, what format should the Data on File take as it is not possible/desirable to provide the whole document as data on file. Thank you.

Question 483

Wed, 22 Oct 2025 20:49:49 GMT

In fictitious patient profile, is it acceptable to give "results" for the patient, if they align with clinical trial data that is presented elsewhere in the APS?

Question 484

Wed, 22 Oct 2025 20:49:47 GMT

What happens when a piece which contains information on multiple drugs is already approved by PAAB but then a product monograph update comes out for one or more of the drugs. Does this require revision and re-submission or is the piece still valid for the duration of the approval period?

Question 485

Wed, 22 Oct 2025 20:49:45 GMT

If there are updates to safety information, is there a grace period that PAAB allows before pieces have to be updated with the new label?

Question 486

Wed, 22 Oct 2025 20:49:43 GMT

Dear PAAB, Would a message that makes reference to the brand name and indication of a company's vaccines, that is intended to be posted on the company's intranet, for the purpose of informing the company's employees on what vaccines the company makes and which disease they intend to prevent, be considered promotional and require PAAB preclearance? if yes, would it make any difference if a disclaimer is added to prevent employees from sharing the information with outside people? Thank you!

Question 487

Wed, 22 Oct 2025 20:49:41 GMT

Hi PAAB, would product related messages posted on the intranet of a company for employees' information be considered direct to consumer advertisement, given that the intranet is accessible to any employee of the company but not to people from the outside? Thank you!

Question 488

Wed, 22 Oct 2025 20:49:39 GMT

What are the evidence requirements for case studies within an unbranded piece? The cases in question outline a patient's circumstances and presentation, and then provide faculty opinion/recommendations on appropriate courses of therapy (without specifying the results of the recommendations). In some cases, patients have previously failed to get symptom relief while taking other agents. (I've searched the PAAB website and haven't found this addressed anywhere. Many thanks in advance for any guidance.)

Question 489

Wed, 22 Oct 2025 20:49:38 GMT

Where can I get the detail guidance around layouts (ie, font size, specific/mandatory placement of info etc)? Thanks.

Question 491

Wed, 22 Oct 2025 20:49:36 GMT

Healthcare professionals have asked for demo syringe kits to show patients how to inject. Would this be something we would submit to PAAB for review? It would have the product name on the box, and include: demo syringes, a squeeze ball, and a dose card in the kit that was previously PAAB approved? Would it matter if a dose card was not included? To summarize, does a demo kit fit Code Section 6.6 (iv) .....use of a drug name only in a context not linked to therapeutic or promotional messages. Or is it considered a Service-Oriented Vehicle under Code section 6.4, even if it's a demo kit?

Question 492

Wed, 22 Oct 2025 20:49:34 GMT

We will be running a webinar from our HCP website. The webinar will be delivered by an internal medical expert. The webinar content will be on-label and pre-cleared. HCPs will need to register for the webinar on the "events" section of our gated HCP website. This section would only contain a list of upcoming webinar events. The description for the webinar would include; title, date, time location and a basic bio of the speaker. If the webinar title does not include mention of any specific products and the remaining info is purely factual details about the event date, time & speaker credentials, does this content need to be pre-cleared by PAAB?

Question 493

Wed, 22 Oct 2025 20:49:32 GMT

Since DTC advertising is not allowed for products that treat or prevent schedule A diseases, I was wondering whether a product that managers a symptom of a schedule A disease (example: hypoglycemic reactions in diabetes) would have the same restriction?

Question 494

Wed, 22 Oct 2025 20:49:31 GMT

On a STI sample card the Brand name is included along with images of the product. Does this need to be PAAB approved or is it exempt (i.e. no claims are included, no indication statement just product name). Thanks

Question 495

Wed, 22 Oct 2025 20:49:29 GMT

If the safety information for 2 products is almost identical (the molecule being the same in both products), can we merge the two fair balances and indicate which safety information is for both products and which safety information is for only one of the products?

Question 496

Wed, 22 Oct 2025 20:49:27 GMT

Hi, would a product announcement with: the name of the product, "now available in Canada", and package shot (with no visible therapeutic claims) be considered paab exempt? if the product came in multiple pill sizes, can a shot of the pills with their sizes be allowable as the product shot?

Question 497

Wed, 22 Oct 2025 20:49:25 GMT

I would appreciation clarification of Section 6.6 of the code related to patient information direct from and consistent with the Product Monograph in combination with gating requirements. If a video is created that walks a patient through how to administer the injection as per part III, does not mention what the product is used for, and that video is posted (with no gating) on the company's website right below the product monograph for that product (as you know companies typically have a page on their company site with all their product monographs posted)......is 1) that video exempt from PAAB review and 2) Can the video be left ungated in this situation (i.e. Does proximity to the monograph pose an issue)? Thank you.

Question 498

Wed, 22 Oct 2025 20:49:23 GMT

As a follow-up to Question 299, we would like to ask if it is acceptable to still post such a video on YouTube but make it an unlisted video.... only found when pharmacist's share the URL with a patient who need to learn how to use the product . Thank you for your help !

Question 499

Wed, 22 Oct 2025 20:49:21 GMT

We are experienced in submitting DTCI campaigns through regulatory. In these cases, the focus is on the disease and when mentioning drugs, we discuss all treatments indicated for that disease (because there cannot be undue emphasis on any one drug). However, we wish to know about the DTCA of vaccines. For example, are we allowed to talk about the indication/side effects/dosing, etc for one vaccine specifically without mentioning the other vaccines indicated for the prevention of the same disease? In this case, it'll have the "undue emphasis" which is not permissible for schedule F drugs.

Question 500

Wed, 22 Oct 2025 20:49:20 GMT

Can you advise on PAAB's role/interpretation of 'drug delivery system' advertising? Examples wold be prescription drug inhalers, injectors, etc. Would advertisements focused solely on the delivery system/technology be exempt from PAAB (perhaps as a medical device), or seen as an extension of drug advertising (and reviewed in the same manner)?

Question 501

Wed, 22 Oct 2025 20:49:18 GMT

The ASC's bulletin in April 2015 indicates that the statement "Product X is authorized for sale by Health Canada" is consistent with the Food and Drug Regulations and acceptable for use. Previous Ask PAAB questions 108 and 347 also address this issue and section C.01.007. We note that Health Canada's Consumer Advertising Guidelines for Marketed Health Products has precluded the use of statements that suggest authorization by Health Canada, and has not been updated since the ASC's bulletin. Can you please provide PAAB's position on the use of the statement above and also whether the use of "approved by Health Canada" or similar statements is acceptable?

Question 502

Wed, 22 Oct 2025 20:49:16 GMT

Is Pharma allowed to sponsor an independently-developed, physician-managed, online discussion forum? Pharma would have no involvement other than to provide funding for its development. What if the discussion forum is managed by Pharma's communication agency?

Question 503

Wed, 22 Oct 2025 20:49:14 GMT

We were granted a new indication based on a pivotal study. However, some datapoints in the published study, in a peer-review journal, are not found in the TMA. We would like to know if it is "off label" for our reps to speak to those data points since it is extra data points in our studied population for which we have an indication? Can they use the reprint and speak to those results?

Question 504

Wed, 22 Oct 2025 20:49:12 GMT

Dear PAAB Can the branding of disease specific information for medical professionals resemble the branding of a product not yet launched? (i.e. Does PAAB place any restrictions on the branding of disease specific information and product APS?)

Question 505

Wed, 22 Oct 2025 20:49:10 GMT

Dear PAAB - would a branded APS comprised of only a provincial listing (with clinical criteria/notes), require high-level balance or low-level balance? Note this assumes that all listing criteria is on-label.

Question 506

Wed, 22 Oct 2025 20:49:08 GMT

Hi! Do corporate branded educational tools (no claims or messaging) need to be reviewed at paab? For example : knee bone joints? Or skeleton etc Thanks!!

Question 507

Wed, 22 Oct 2025 20:49:07 GMT

The PAAB does not allow the use of post-hoc study analyses to support claims. Are there any exceptions to this? For example if the post-hoc analysis was done for safety reasons at the request of the FDA, would that publication be permitted to support claims?

Question 508

Wed, 22 Oct 2025 20:49:05 GMT

If exacerbation rates are provided in a publication with other details with which NNTs can be calculated, would PAAB allow us to promote the NNTs?

Question 509

Wed, 22 Oct 2025 20:49:03 GMT

I am wondering how or if section 103.2 of the Natural Health Product Regulations factors in to the review of NHPs as it appears to exempt some NHPs from part of section 3(1) of the Food and Drug Act.

Question 510

Wed, 22 Oct 2025 20:49:01 GMT

How long does PAAB approval on DTC last? 1 year or 2 years?

Question 512

Wed, 22 Oct 2025 20:48:59 GMT

Can you please clarify why product MOA can only come from the TMA, and not published, peer-reviewed in vitro studies? MOA is frequently characterized post-NOC, particularly for products where ‘the exact mechanism of action is unknown’.

Question 513

Wed, 22 Oct 2025 20:48:57 GMT

Section 3(1) of the Food/Drugs Act implies DTC-A is prohibited for products treating Schedule A diseases. Yet, there seems to be many approved DTC-A campaigns for STDs, Arthritis, etc. How is Section 3(1) being implemented in PAAB practice?

Question 514

Wed, 22 Oct 2025 20:48:56 GMT

Good morning, Can we disclose the name of the company behind an unbranded website, when such is being asked in a specific tweet? Thanks in advance

Question 515

Wed, 22 Oct 2025 20:48:54 GMT

We would like to ask PAAB regarding the interchangeability of the term “starter pack” used to identify a traditional sample pack. Certain products have starter packs specifically designed to initiate patients on treatment and help avoid dosing errors and contain patient educational materials. Our question is whether it is possible to refer to a simple sample pack as a “starter pack” when it is not specifically designed as a starter pack and is not mentioned in the TMA?

Question 516

Wed, 22 Oct 2025 20:48:52 GMT

I am wondering if we are able to create stickers for our material to indicate that we have formulary however I would like to keep it simple and say something like "Now on formulary (special authorization) in your province" or "...in this province" without specifying the province itself. We would of course only place these stickers on tools where the province has received formulary and we would of course provide PAAB with an FYI as to what tools and where we would be placing the stickers. Is this doable?

Question 517

Wed, 22 Oct 2025 20:48:50 GMT

Is it possible to produce a teaser ad for a product? Does this ad need to be disease oriented "Something new in X disease area coming soon" or can a brand name be attached to it such as "Brand X coming soon"? Lastly, does this require PAAB review? Thanks you for your guidance.

Question 518

Wed, 22 Oct 2025 20:48:49 GMT

Commercial employee asked a presenter AFTER presentation at a scientific conference why DRUG X has not been included in his presentation. DRUG X has not yet been approved by Health Canada but belongs to the employee's company pipeline. DRUG X efficacy/safety properties have not been discussed. Does this interaction constitutes off label promotion?

Question 519

Wed, 22 Oct 2025 20:48:47 GMT

We are sending an announcement to HCPs informing them that a product is now covered on the provincial formulary and providing the the reimbursement criteria. My questions are: Are we required to include the reimbursement criteria? What level of fair balance is required?

Question 520

Wed, 22 Oct 2025 20:48:45 GMT

Health Canada's policy "The Distinction Between Advertising and Other Activities" states that materials emanating from a parent company presented during an International conference would not require PAAB review, provided that they are only used within the confines of the conference and are prominently identified as "not being authorized for sale in Canada". However, when a product presented in a promotional booth is approved in the US and in Canada as well, if: - all the material clearly specifies that all the information comes from the US labelling/Marketing Authorization, and - the target audience is from the US and not from Canada, even though some Canadian HCPs could be attending, will this be still considered as promotional activity in Canada and require a pre-clearance form PAAB?

Question 521

Wed, 22 Oct 2025 20:48:43 GMT

We currently have an APS submitted for PAAB review. We have experienced a delay in the project and we may not be able to respond to the last PAAB letter that we received for another 4-6 months. Is there an expiration on how long an unapproved e-file will stay open within our "Submissions" portal for PAAB to receive a response?

Question 522

Wed, 22 Oct 2025 20:48:41 GMT

Can the "Summary Basis of Decision" from Health Canada be used for advertising claims?

Question 523

Wed, 22 Oct 2025 20:48:39 GMT

Hello, I would like clarification on how efficacy data and mechanism of action data can be presented together in a promotional piece. My understanding is the MOA is considered non-clinical and therefore must be physically separate from efficacy or clinical claims. Is this assumption correct? I am not sure why this would be. Can you please explain why I cannot mention how a product works and how well it works together in a page? Thank you,

Question 524

Wed, 22 Oct 2025 20:48:38 GMT

Hi PAAB. Do communications sent in the context of a patient assistance program need PAAB preclearance? here is the situation. we have a patient assistance program for which we would like the vendor to use a standardized and automated system to communicate information pertinent to patient's enrollment status, notifications regarding reimbursement investigations, reminders of missing information to proceed with the service etc... The issue is that all of our Patient assistance programs are named after the therapeutic area (XYZ-Onclogy; XYZ hep C, XYZ HIV...) and within the body of the letter we have to specify the name of the product for HCP to know which product the communication is related to. These communications begin after a physician has made the decision to prescribe the product and decided to enroll his patient into the program either for reimbursement investigation or compassionate drug provision. We were wondering since we want the communication to be standardized (create template with blank space to be filled with the patient's name or initial and appropriate identifiers) and send through an automated system, and since the designation of the program mentions the indication (hep C for instance) and the body of the letter has the name of the product, do we need PAAB preclearance or would these type of communication be exempt as per PAAB code. thank you.

Question 525

Wed, 22 Oct 2025 20:48:36 GMT

Can you please clearly define what is meant by a non-clinical claim? Non-clinical claims can include anything from IMS data (#1 prescribed claims), dosing, administration and quality of life. How do these fit under one umbrella?

Question 526

Wed, 22 Oct 2025 20:48:34 GMT

On an unbranded, consumer-facing, disease state website, it is permissible to discuss differential diagnosis? As in, could you "compare" the symptoms of the website condition with another, similar condition with overlapping symptoms?

Question 527

Wed, 22 Oct 2025 20:48:32 GMT

What is the equivalent of product monographs for NHPs? Is it the Product Label , the Product Insert, or the Evidence Summary Report that we are submitting to Health Canada? For instance, if we want to include some precise figures in the promotional material for HCPs, do we need to include them in the Evidence Summary Report? Also, to obtain the right to have a graph or a table in the promotional material to HCPs, is the mention of the figures enough in the document that acts as an equivalent to the Product Monograph, or do we need to include also the graphs/tables?

Question 528

Wed, 22 Oct 2025 20:48:31 GMT

On a company website, would we be able to show a picture of a drug along with name, price, quantity and product monograph? Would we be able to also link this drug page to a medical device that it is intended to be used with?

Question 529

Wed, 22 Oct 2025 20:48:29 GMT

Hi, I have a question about 3.1 specifically the section regarding claims consistent with the limitations of the Health Canada Terms of Marketing Authorization. There are some on our team that believe this means we are not able to use data that is not within the PM regardless. There are others that believe if a claim is based on a similar study population, endpoint and outcomes are consistent with the monograph, it appropriate. We seem to go back and forth on this a great deal and I like to hear PAABs thoughts. Thanks

Question 530

Wed, 22 Oct 2025 20:48:27 GMT

What is PAAB's position on proactively providing storage/stability information to customers that is different than what is in the Product Monograph, but which is supported by clinical data? We sell a product that requires refrigeration between 2-8 degrees. Our Med Info department receives many, many calls inquiring about temperature excursions outside of the labelled storage conditions. We have data to support the excursions. We would like to be able to proactively provide temperature excursion data to customers to make it easier for them to know what to do if they experience an excursion...and so that they would not always need to call us. Is this permitted?

Question 531

Wed, 22 Oct 2025 20:48:25 GMT

Re: Q#522 for use of Summary Basis Decision in advertising and you replied: "Yes. Provided the content referenced from it is not inconsistent with the product monograph", if data from the SBD does not appear in the PM, can we use it? It would not be 'inconsistent'. If PAAB considers the SBD the same weight as the PM, then it should be acceptable. Is this an accurate assessment?

Question 532

Wed, 22 Oct 2025 20:48:24 GMT

We have a PAAB-approved print piece that we would like to use in a digital environment. None of the content of the print piece will change, but the layout will be different. Would it suffice to submit the new layout with the approved print-piece e-file number or will you need to re-review the content (i.e., need a copy deck)?

Question 533

Wed, 22 Oct 2025 20:48:22 GMT

For a piece which speaks to the safe handling of a drug product for HCPs, is fair balance required.

Question 534

Wed, 22 Oct 2025 20:48:20 GMT

Hello! We, working on behalf of a European based pharma-company, are planning to sponsor an industry symposium at a 'World Congress' being held in Canada, in 2017. The content of the symposium will be generated by external speakers/expert clinicians. There may be some information/published data presented, relating to the sponsor's and other licensed pharmaceutical products, within the speakers' lectures, related to the wider context of the 'management and treatment' of the condition/s. Do the slides and any other related scientific content, for a symposium within a 'World Congress' setting, need to be submitted for review and approval by PAAB? The sponsoring company's products are licensed in Canada. Thank you, in advance, for your guidance; we appreciate your support.

Question 535

Wed, 22 Oct 2025 20:48:18 GMT

The manufacturers of a drug would like to provide patients (via HCPs) with a wallet card that alerts the patient to show the card to healthcare professionals to remind them to check for potential drug interactions. This focused bit of information is consistent with Part III. Does this require PAAB review?

Question 536

Wed, 22 Oct 2025 20:48:16 GMT

Hello. I work in the advertising industry, and have been discussing with a prospective client a direct mail piece in support of a prescription product. I understand that you cannot communicate the product name and specify what what malady it treats, but it must be a generic message advising to speak to their healthcare practitioner. My question is that if I were able to source a list of individuals who have reported having this condition, could I send this generic unbranded awareness piece to that identified person?

Question 537

Wed, 22 Oct 2025 20:48:15 GMT

Can a sales rep use a slide deck that discusses the study design, inclusion/exclusion criteria, and patient characteristics for study in an indication for which they don't yet have approval?

Question 538

Wed, 22 Oct 2025 20:48:13 GMT

What are the implications, if any, for a Product having "monotherapy" in the dosing section vs in the indication section of the PM? Does it matter that it's under "dosing considerations" as opposed to "indication" if it's still on the Product Monograph? How would PAAB limit advertising for this? Would the sponsor only be able to mention monotherapy, if at all, if: (1) they use the verbatim statement from the PM, (2) they don't put that statement with the indication statement and (3) they don't make monotherapy the main theme of the APS?

Question 539

Wed, 22 Oct 2025 20:48:11 GMT

When submitting an APS for approval, can we submit the piece with the intent that it will be presented to HCPs in both a print format and a digital format as one submission? (Note - the content and layout of the piece will appear exactly the same in both modes of delivery).

Question 540

Wed, 22 Oct 2025 20:48:09 GMT

Hello, Suppose a vaccine product launches a branded Facebook page: The rules surrounding promotional posts are relatively clear, but what are the guidelines are on content curation? For example, including a link to an article from a publisher such as the CBC that discusses the condition but with no mention of the brand, or sharing a post from a lifestyle blog that similarly does not reference the brand/vaccine but may be relevant to followers of the page. The Health Canada policy on "The Distinction Between Advertising and Other Activities" does not seem to include this particular type of scenario explicitly. Could you provide some guidance or a link to the relevant guidelines? Thank you.

Question 541

Wed, 22 Oct 2025 20:48:08 GMT

Can you please advise if CADTH Common Drug Review publications can be used as evidence for efficacy, pharmacoeconomic or recommendation claims?

Question 542

Wed, 22 Oct 2025 20:48:06 GMT

Can DTC and HCP branded materials have the same headline/creative, if the DTC ad is approved by ASC and the HCP ad by PAAB? Can the DTC ad, if it is digital, link to a gated HCP portal?

Question 543

Wed, 22 Oct 2025 20:48:04 GMT

We are building a website which would contain medical information only. The website will be gated with a registration & log-in process that only allows entry to Canadian HCPs. In an effort to improve the search engine ranking of our website, we would like to optimize our website for organic search (SEO), which would include using a JavaScript log-in page that would allow search engines to crawl the pages beyond the gate. We would not offer the ability to access content on the website without registration and login validation, the purpose of allowing search engines to crawl the pages beyond the gate is simply to allow our website to appear in organic search rankings for specific key word searches. Is this permissible under the Code?

Question 544

Wed, 22 Oct 2025 20:48:03 GMT

If the Canadian affiliate creates materials for a booth (panels, TV screen, etc.) at an international conference being held in Canada, can handouts from the US affiliate be included/distributed?

Question 546

Wed, 22 Oct 2025 20:48:01 GMT

If I buy keywords that are associated to a gated website does it have to be submitted to PAAB? The targeted audience is consumer and not HCP. Thank you.

Question 547

Wed, 22 Oct 2025 20:47:59 GMT

What type of reference is needed to claim absence of a specific excipient in a product? Would the fact that the specific excipient is not mentioned in the product monograph be enough to support this type of claim, or would some sort of certification of absence be required? For example, gluten free certification?

Question 548

Wed, 22 Oct 2025 20:47:58 GMT

1. Can a modified intent-to-treat (mITT) analysis be used in promotional materials? mITT analysis excluded patients who discontinued due to adverse event, lost to follow-up, or subject withdrawal. 2. If yes, would also need to show the primary endpoint analysis, ITT, as shown in the PM? 3. Are there any specific requirements on how the primary ITT and mITT analyses need to be displayed?

Question 549

Wed, 22 Oct 2025 20:47:56 GMT

A company is entering into a new disease state in which they don't already market a product in Canada.If they produce a corporate ad (pre NOC) indicating that they are now entering into the therapeutic area/disease state, can they mention the therapeutic area/disease state in the ad?

Question 550

Wed, 22 Oct 2025 20:47:54 GMT

Can a company have a corporate pre-launch journal ad that speaks to an unmet need/care gap for a disease state that they don't yet have a product?

Question 551

Wed, 22 Oct 2025 20:47:53 GMT

We have a patient survey conducted by a patient association looking at reasons for stopping therapy. Can we use this information in an unbranded APS to highlight the most common reasons for stopping therapy?

Question 552

Wed, 22 Oct 2025 20:47:51 GMT

In the indication for a product has been updated (ie. expanded), can you put a "New" sticker on the front page of the Product Monograph for distribution to HCPs?

Question 553

Wed, 22 Oct 2025 20:47:49 GMT

Can you use "New" in APS for a product that has been on the market but has had their indication revised/expanded?

Question 554

Wed, 22 Oct 2025 20:47:47 GMT

On an HCP gated website that provides branded drug information, is it mandatory that the very first page after the gate is cleared be the "safety information" for that drug? Assuming the "safety information" link is accessible from the main navigation menu, can the landing page after the gate be some other content? Thanks.

Question 555

Wed, 22 Oct 2025 20:47:46 GMT

Can we provide a link from our disease state page on our local website to our global disease state page containing information about the same topic? If a disclaimer pops up prior to the user leaving the Canadian website and viewing content on that disease state global page, are we able to do this?

Question 556

Wed, 22 Oct 2025 20:47:44 GMT

Can we provide marketing items such as pencils, cups or post-it with braded name only of future prescription drug currently under NOC review (not approved yet in Canada) but FDA approved. Distribution would be to general Canadian public and health care practionners during Canadian conventions.

Question 557

Wed, 22 Oct 2025 20:47:42 GMT

When advertisers work with the PAAB for a pre-clearance approval what do they receive in terms of official approval?

Question 558

Wed, 22 Oct 2025 20:47:40 GMT

If we are developing a postcard with a link to a patient education website on it (website will go through ASC approval) that is designed for the sales rep to give to an HCP to give to their patients, will PAAB have to review the entire website who's link is on the card? The website will have nothing brand specific, it will display all treatment options for patients, however it will have the company logo on it. Thanks!

Question 559

Wed, 22 Oct 2025 20:47:38 GMT

Exactly when does a 'consumer' become a 'patient' -- is it the point at which they receive a prescription for a specific brand, or when they are dispensed a specific brand? In certain therapeutic categories (eg., epinephrine, insulin), patients receive a prescription for the molecule, which can be associated with multiple brands. At this point before a specific brand is selected, is it permissible for an HCP to expose the 'consumer/patient' to branded material, in order to facilitate brand selection? This scenario assumes that all brand options would contain the identical active molecule.

Question 560

Wed, 22 Oct 2025 20:47:37 GMT

As follow-up to Questions 291/328/500, would medical device (class II)-sponsored advertising be subject to PAAB review, if comparisons were made between the medical device and a non-medical (drug-containing) device?

Question 561

Wed, 22 Oct 2025 20:47:35 GMT

I realize that ads with only name, price, and/or quantity are considered exempt. If I was to compare the price of Drug X to Drug Y, and have a statement that said "Drug X offers a __% savings vs Drug Y", would this be considered promotional and render it non-exempt?

Question 562

Wed, 22 Oct 2025 20:47:33 GMT

Can we develop a sales aid where the user can select specific topics (efficacy, safety, cost) and then present these to a physician? The concept is to create a custom presentation based on the needs of the physician. So if a physician only wants to hear about efficacy and cost, those would be the only sections to appear. This would be like adding tabs to a print sales aid but since digital, we can create the sections that will appear based on the customers need

Question 563

Wed, 22 Oct 2025 20:47:31 GMT

If an advertiser is looking to target an ad to healthcare professionals, what is the accepted definition of "healthcare professional" and how strictly enforced by Health Care Canada is the requirement of that targeting?

Question 564

Wed, 22 Oct 2025 20:47:29 GMT

Based on advisory board recommendations for supportive tools, a company would like to create an unbranded "reference tool" which documents the metabolic pathways for drugs in a particular therapeutic area. This would be a service item distributed by the representatives. Information would be taken primarily from Product monographs and in a few cases, the literature. Is there any reason this would not be allowed? what would be the constraints?

Question 565

Wed, 22 Oct 2025 20:47:28 GMT

Could you please clarify the formulary message for the province of Québec. If a company mentions the following message: “Drug X: Now on RAMQ formulary (médicament d’exception code)” and not linked in any way to additional product messages or disease/corporate messages. We would not allude to the indicated use and will add the RAMQ TM. Is the above mentioned text still PAAB exempt or not. Are we in the obligation in Québec to provide code and coverage criteria every time we mention RAMQ reimbursement (then subject to PAAB). I have read the information on the PAAB website, but still having different interpretation/confusion on this. • Memo dated April 15, 2016 - Advisory regarding use of Régie de l’assurance maladie du Québec (RAMQ) in APS • PAAB ADVISORY guidance on Provincial Formulary Coverage Statements • Q 519 in the Ask PAAB section

Question 566

Wed, 22 Oct 2025 20:47:26 GMT

Hi PAAB, Section 1 of the Code provides that it applies to APS directed to HCPs (as well as patient information distributed via HCPs). Corporate websites target consumers rather than HCPs. However, it seems that PAAB considers corporate websites presenting information on the company's products as corporate APS (s. 7.4 of the Code) that must be submitted to PAAB. Does it mean that the Code also applies to material that does not target HCPs? If the corporate website presents general information on a disease or a class of products, does it need to be submitted to PAAB or would it be considered as DTCI? Thank you.

Question 567

Wed, 22 Oct 2025 20:47:24 GMT

We would like to know if we can make a claim about the % of patients who would recommend a specific treatment to other patients. The % is published in a retrospective study done on patients who were taking this specific therapy. It is a patient reported outcome that is not in the Product Monograph. Please advise if there is any way to put such a claim through.

Question 568

Wed, 22 Oct 2025 20:47:22 GMT

Questions in regards to provincial formularies: 1. Would providing the name of the "product now on province formulary" statement with the inclusion of the din number for ordering be considered exempt from PAAB? 2. If the link to the complete provincial formulary is included would this be considered the same as including the coverage criteria for the product? 3. Is including the complete provincial formulary link and directing to the section or page for product "X" be considered as providing the coverage criteria and thus requiring PAAB review?

Question 569

Wed, 22 Oct 2025 20:47:21 GMT

Can you use before and after photos that show a drug's efficacy in a patient brochure?

Question 570

Wed, 22 Oct 2025 20:47:19 GMT

Hi, We would like to highlight specific market data for our brand. We seem to fall into the guidelines that PAAB has put together but the specific data we would like to highlight is the new patient share (this consists of naive and switch patients). It would be a "leader" or "#1" claim. This data is from the private payer database (RxDynamics). Is this type of data allowable? I've done leader market claims as it relates to the total prescriptions dispensed but have never tried this type of data. Thank you.

Question 571

Wed, 22 Oct 2025 20:47:17 GMT

Are Naturopathic Doctors included in the definition of 'health care practitioners' when determining whether promotional material needs to be reviewed by PAAB?

Question 572

Wed, 22 Oct 2025 20:47:15 GMT

As part of our initial approval for a drug, we currently have an indication for the treatment of condition X. An additional trial has been published for cancer patients with condition X. The dosing remains consistent with the initial TMA. Can we promote our drug for cancer patients with condition X?

Question 573

Wed, 22 Oct 2025 20:47:14 GMT

Hi, Is it allowed to develop a tool for physicians that will be used with a patient to help the patient make the decision to use a specific therapy? if yes, should the information in this tool restricted to Part III of the PM only or other sources are also allowed? Thank you!

Question 574

Wed, 22 Oct 2025 20:47:12 GMT

I intend to submit a non-branded APS into PAAB shortly. One call to action we are considering is a link to a URL that has been ASC approved (but not PAAB approved). We intend to link to not the whole site, but rather a particular section of the site. Would this subject the entire website to PAAB review?

Question 575

Wed, 22 Oct 2025 20:47:10 GMT

Our question is related to question no 70 which was: "The PAAB codes allows side by side comparison of non-clinical data from 2 or monographs. Would it be acceptable to use a comparative table of non-clinical data (ie. pharmacokinetics) from a review article? Extract from 5.10.2: [Information from two or more Product Monographs on products' properties7 and on instructions for use or use limitations8 may be acceptable as side-by-side presentations and in text form.]". PAAB answer: "The PAAB Code (s3.1.1) does not regard "review articles" as high level evidence to support a drug specific claim because they reflect an opinion/ summary from an author rather than actual findings of a primary study. This also applies to non-clinical claims. Our question: Does PAAB regard "Guidelines" (such as CGA guidelines) as high and appropriate level of evidence for a side-by-side comparison of use limitations? Thanks

Question 576

Wed, 22 Oct 2025 20:47:08 GMT

We are in the process of developing a tool that will highlight a product's reimbursement program. It would state "reimbursement navigation assistance available for Product X" and would include a tear pad with necessary information to be completed by an HCP. This tear sheet would not be provided to patients, but would be faxed directly to the manufacturer. In addition, this tool would not include any product/promotional claims, only the name of the product would be mentioned. Given that messages limited to name and price are exempt from PAAB review, would "reimbursement navigation" also be considered exempt? If not, is there any way to make this tool exempt?

Question 577

Wed, 22 Oct 2025 20:47:07 GMT

Hi - I understand that as per Section 6.6iv, an email informing HCPs about 'updated provincial formulary criteria for Drug X' would be considered PAAB exempt (if there were no linkage to therapeutic or promotional claims). Could you provide clarification on whether including a website link to the full formulary list of a province would still be considered exempt? Note that this formulary list contains criteria specific to Drug X.

Question 578

Wed, 22 Oct 2025 20:47:05 GMT

Hi PAAB: We have a new product in our pipeline that is currently undergoing approval process with Health Canada (pre-NOC). We want to do a targeted campaign to HCPs around disease state, We will not be mentioning any clinical data or clinical options. This online piece will be centered around the disease and very general information regarding disease state. Do we need PAAB approval or ASC approval alone is sufficient?

Question 579

Wed, 22 Oct 2025 20:47:03 GMT

When a disease is very rare, there is often no published Canadian specific epidemiology or incidence studies. What is PAAB's position on allowing a simple statement that the disease is 'rare'?

Question 580

Wed, 22 Oct 2025 20:47:01 GMT

Hi, My question pertains to the construction of the required "Relevant warnings and precautions" section include in a fair balance section. Specifically, can the incidence of the events, for example "serious adverse events of neoplasm' or "QTc prolongation", have incidence or other clarifying information included in the fair balance section for clarification purposes so a HCP more clearly understands the context of the warnings and precautions?

Question 581

Wed, 22 Oct 2025 20:47:00 GMT

For an efficacy claim, comparing head-to-head results of the study drug vs. the standard treatment, what support is required to justify the claim "significant"?

Question 582

Wed, 22 Oct 2025 20:46:58 GMT

Can NBRx data be used to make market share claims, if the same principles governing TRx data were applied? Example: Arbace is the #1 dispensed hypertensive among new patients. If so, would the NBRx data need to be directionally consistent with the TRx data (ie. if Arbace is in fact not the #1 dispensed among ALL patients)?

Question 583

Wed, 22 Oct 2025 20:46:56 GMT

A product receives an updated indication, removing some clinical use restrictions (patient type, duration, etc). Can the old and new indications be presented together in an APS? Can an APS make mention of the lifted clinical use restrictions (if they are now omitted from the TMA)? Thank you.

Question 585

Wed, 22 Oct 2025 20:46:54 GMT

Hello - I understand that data exceeding the duration of the TMA is not acceptable (eg. TMA study A is 1 year in duration, new study B is 2 years in duration). However in a situation where a registration trial is designed to read out to 3 years, and the TMA only contains year 2 data, is it acceptable to include year 3 data in APS? Would this be dependent on the year 3 data being directionally consistent with the year 2 data?

Question 586

Wed, 22 Oct 2025 20:46:53 GMT

If a leading pharmaceutical company provides funds for an article on adult immunization but without having any control on the content of the article, can the disclaimer at the end of the article read "brought to you by a leading pharmaceutical company" or does it have to specifically mention the name of the company that provided the necessary funding.

Question 587

Wed, 22 Oct 2025 20:46:51 GMT

Can you please tell us more regarding gated medical information websites. What would be considered an effective and PAAB compliant gate? Verify each HCP by License #? HCP number pattern (do we need to use specific pattern depending on the type of HCP eg: Nurses, Pharmacists, Physicians. and the province)? Thanks

Question 588

Wed, 22 Oct 2025 20:46:49 GMT

I would like to clarify the requirements for a PAAB material review in relation to a US-only promotional symposium at an international congress held in Canada. Our US colleagues would like to host a learning theatre program on a product that is approved for use in both the US and Canada. If the program is US-developed (independent of Canadian input) and presented to a US-Healthcare professionals audience only, is the material developed subject to PAAB review? A few mitigation steps would be in place: • All learning event promotional tools (such as the invitation) will state that Canadian physicians and any Canadian healthcare professionals (HCPs) will not have access to this event. • A check-in safeguard system will be set up at the entry of the event (such as checking and scanning the badges) to ensure access is only granted to US-HCPs. • A disclaimer will be included at the bottom of each slide of the presentation clearly stating that all information is based on the US prescribing information • The local internal review team will review and attest to the presence of this disclaimer before the slide deck can be used at the event. Thank you in advance.

Question 589

Wed, 22 Oct 2025 20:46:47 GMT

Hi there, I am currently creating a slide deck that the reps will use with their customers, and I am wondering how PAAB would like market research to be referenced? Is the project name, source, and date sufficient, or is there more information that PAAB requires? Thanks!

Question 590

Wed, 22 Oct 2025 20:46:46 GMT

Hello, We plan to create a survey to gather statistics on lifestyle habits and general knowledge of the respondents on a virus in order to use the said metrics in a promotional tool, in the vaccination field. 1000 respondents is the usual number needed to produce relevant or serious statistics. The question is: As per PAAB's guidelines, is there a minimum number of respondents needed in a survey to be able to use the statistics produced by it in promotional tools. Thank you

Question 591

Wed, 22 Oct 2025 20:46:44 GMT

HI PAAB, when a drug goes from pre-NOC to NOC, is it possible to use the wording "Now Approved In Canada". Also, if this is marketed to general population, does it need PAAB approval? Thanks

Question 593

Wed, 22 Oct 2025 20:46:42 GMT

We would like to do an unbranded piece based on treatment guidelines. There are no Canadian treatment guidelines for this disease. Can we use a European guideline (not for a particular country but from a European society (endorsed or recognized by an authoritative medical body)? Can we use two guidelines together, the European and the US guideline? If some of the products are not authorized in the same way in Canada as recommended in the guidelines, should we not mention that use or we should clarify that is not the way that is indicated in Canada? Thank you for your help.

Question 594

Wed, 22 Oct 2025 20:46:40 GMT

For non-prescription marketed health products, is it a requirement to include a product's DIN or NPN on an advertisement/promotional piece directed at a healthcare professional?

Question 595

Wed, 22 Oct 2025 20:46:39 GMT

Will PAAB approve MOA comparison around selectivity in an unbranded leave behind - content is not from individual TMAs but from recent post-NOC invitro peer reviewed paper?

Question 596

Wed, 22 Oct 2025 20:46:37 GMT

A disease-state piece includes mention of treatments in a balanced manner. It is distributed to consumers as a Consumer Brochure and technically exempt. Can this same piece be distributed to HCPs, or would it have to be revised to meet Editorial APS requirements? Does the content and/or level of detail dictate this?

Question 597

Wed, 22 Oct 2025 20:46:35 GMT

We have Data on File that was part of an NDS, but was not explicitly included in the TMA. We feel Health Canada has 'accepted' this DOF, by virtue of related label negotiations and direct correspondence. What type of proof would PAAB require to consider use of the DOF in APS: Sponsor Regulatory confirmation, Sponsor correspondence with Health Canada, contacting Health Canada directly on behalf of the Sponsor, etc?

Question 598

Wed, 22 Oct 2025 20:46:33 GMT

Seeking some clarification on the response to Question #273. Can you confirm that the answer "It may be exempt if all the treatments are balanced" applies only if the piece in question is consumer-directed? We're assuming that HCP-directed exempt material (s6.6) can never mention treatments (balanced or not), otherwise it would be considered Editorial (s7.5).

Question 599

Wed, 22 Oct 2025 20:46:32 GMT

Suppose a Product Monograph contains pooled data presentations (demographics, efficacy, safety, etc), but the individual data sets are from separately conducted and published studies, with no planned pooling. Would it be acceptable to report the individual data in APS, or would PAAB require it to remain pooled (and subject to the associated limitations). Traditionally pooled data are not regarded as high-level evidence, but in some cases Health Canada has requested the pooling of data, not the study design itself.

Question 600

Wed, 22 Oct 2025 20:46:30 GMT

Regarding Code s3.1.1, does PAAB distinguish between different types of "pooled data"? For example a post-hoc pooled analyses of unrelated trials (low evidence), vs. a pre-specified pooled analyses of replicate trials (higher evidence)? Such pre-specified pooled analyses are commonly used in registration trials for certain therapeutic categories, and therefore interpretation of s3.1.1 could potentially be biased.

Question 601

Wed, 22 Oct 2025 20:46:28 GMT

I have a question regarding MOA and Code Section 3.1. Suppose a TMA states that Product-X targets receptors A & B, with no additional information/limitations. It is known that Product-X also targets receptors D & E, although this information does not explicitly appear in the TMA (as it is not intended to be a repository of product information). Why would this additional information not be allowed under s3.1? We have seen s3.1 interpreted differently when applied to different sections of a TMA (eg. MOA has a highly conservative approach whereas other sections have greater latitude). Thank you.

Question 602

Wed, 22 Oct 2025 20:46:26 GMT

What is PAAB position on the use of the word NEW in the claim New in Canada. I know that NOW in Canada with only the brand (no other claim) is PAAB exempt, would NEW in Canada be too?

Question 603

Wed, 22 Oct 2025 20:46:24 GMT

Hi, We were thinking of providing our reps with iPad covers that have images from a campaign that we intend to launch. The iPad covers will be solely for the reps and won't have any sort of messaging on them, but will have the names of our brands. Do we need to put the covers through PAAB? Thanks.

Question 604

Wed, 22 Oct 2025 20:46:23 GMT

What are the requirements/limitations for emailing of Enrollment Forms to HCPs for the purpose of enrolling their patients in a PSP? We have developed an Enrollment Form (approved by PAAB) of which we have a version that is a writeable PDF (text fields can be filled out on the computer) to then be printed and signed, and would like to email this Enrollment Form to HCPs directly via the reps. Could you please inform me if this contravenes any PAAB regulation? I was unable to find anything in the PAAB code that would suggest this. Thank you!

Question 605

Wed, 22 Oct 2025 20:46:21 GMT

Hi, We are a health clinic interested in running a publicly funded flu shot campaign for the public. We want have free coffee cards and lollipops to give to anyone who comes in and gets a flu shot. Are we allowed to advertise in a flyer and emails to the neighbourhood businesses specifying that anyone who comes in and gets a flu shot will get a lollipop ad free coffee cards? What are the regulations surrounding advertising our flu shot clinic? Thanks!

Question 606

Wed, 22 Oct 2025 20:46:19 GMT

Hi! We would like to know what the role of PAAB is? Do you support innovation or the pharmaceuticals? This is not meant to be prejudiced in anyway. We've tried to work with pharmaceuticals to put a product that could eventually replace vaccines, replace the current international immunization plans, prevent outbreaks and epidemics.These are just starters. We've conducted full scale animal trials and safety trials and will soon be ready for Phase 1 trials for Universal Flu, HIV/AIDS, Cancer for leukemia and Hodgkin's, all enteric diseases and one to replace the immunization program. I see from PAAB's membership there are a lot of pharmaceutical and vaccine companies represented. We've approached several foundations, vaccine companies and pharmas and got similar "not interested" responses.

Question 607

Wed, 22 Oct 2025 20:46:18 GMT

Does a HCP-directed website for a Schedule D vaccine need to be gated?

Question 608

Wed, 22 Oct 2025 20:46:16 GMT

If we pay for a beauty expert to talk about one of our OTC products live on a tv show like Breakfast Television (on City TV), should the beauty expert mention live on the show that they are being paid by a pharmaceutical company?

Question 609

Wed, 22 Oct 2025 20:46:14 GMT

Hello. Can a pharmaceutical company post a tweet on its Twitter platform about its product winning a research/innovation prize? For example, "Congratulations to Product X for winning the 2017 YZ Prize!"

Question 610

Wed, 22 Oct 2025 20:46:12 GMT

The Guidance document 'Claims Based on Non-Inferiority Trials' states that "In the event the non-inferiority study failed to demonstrate superiority in the primary endpoint, one should not use secondary endpoints to suggest superiority." Does this still apply if the primary/secondary endpoints are unrelated (eg. primary endpoint is an efficacy measure, secondary endpoints are safety measures)?

Question 611

Wed, 22 Oct 2025 20:46:11 GMT

Section 3.1.10 of the Code states that "Secondary endpoints should be identified as such and the primary endpoint of the study should be presented in close proximity when warranted." How do you know when presentation of the primary endpoint is warranted? Is it always necessary to present the primary endpoint when presenting data (i.e., a secondary endpoint) that is in the product monograph?

Question 612

Wed, 22 Oct 2025 20:46:09 GMT

In the context of a Consumer Brochure, is it permissible to provide DINs for a balanced list of medication options?

Question 614

Wed, 22 Oct 2025 20:46:07 GMT

Is it acceptable to advertise a statement that says something along the lines of: "Drug X is the only drug containing active ingredient Y that is approved from clinical tests?" assuming that this statement is true? Would that change if the statement is more specific, such as "Drug X is the only epidural drug containing active ingredient Y that is approved from clinical tests?"

Question 615

Wed, 22 Oct 2025 20:46:06 GMT

Hi, I have a question regarding receiving pre-clearance from PAAB regarding promotional material related to a new product that has been approved under the NOC/c (Notice of Compliance with conditions) policy, as stated in the Qualifying Notice received from HC? Is this mandatory, or optional? Thank you!

Question 616

Wed, 22 Oct 2025 20:46:04 GMT

We're developing a branded slide deck for HCPs that will include mention of adverse events as stated in the Product Monograph. It is our intent to provide HCPs with information on how to manage adverse events (e.g. educate patients on dietary measures, consider consulting a dietitian to modify patient diet if required, etc.). Is it correct to assume that the information on how to manage adverse events within this branded APS must be supported by a textbook or recognized third-party website/materials?

Question 618

Wed, 22 Oct 2025 20:46:02 GMT

Hi there, We have some emails with only company information, no talks about therapeutic area, nothing about brand. We plan to send it through PTM targeting HCPs. Does this need PAAB approval? Thanks

Question 619

Wed, 22 Oct 2025 20:46:00 GMT

We’re working on a new product launch and our client is looking to do a PAAB-exempt pull up banner (just product logo and legal text), however, this product has received an NOC/c approval. Are we required to put the NOC/c box on the banner, which disclaimer sea the indication statement?

Question 620

Wed, 22 Oct 2025 20:45:59 GMT

I have two questions as it relates to pre-NOC submissions. (1) What constitutes a 'final draft' PM? Typically a PM is not deemed 'final draft' by Health Canada until approximately 1 week prior to actual NOC. We would like to make pre-NOC submissions earlier than this. (2) Can we submit a full HCP Detail Aid as a pre-NOC opinion request, or are opinions limited to simple reviews, such as core creative?

Question 621

Wed, 22 Oct 2025 20:45:57 GMT

Has the PAAB ever considered providing review comments as annotations on submission documents, rather than an itemized review letter? This would seem to save both PAAB and Clients time.

Question 622

Wed, 22 Oct 2025 20:45:55 GMT

Hi PAAB. I would like to inquire about the requirements for PAAB material review relating to a company-sponsored symposia (non CME/CHE accredited) being held at an International congress occurring in Canada. The symposia is being developed by the sponsors Global team, with both speakers internal to the organization and some external. If there is no mention of any specific licensed product during the presentations, is PAAB material review required? In another scenario, if case-studies related to a licensed product(s) (vaccine) in Canada were included in the presentation material to provide practical examples and inform the clinical discussion, would the materials require PAAB review? Thanks very much

Question 623

Wed, 22 Oct 2025 20:45:53 GMT

Hi; I have a questions regarding usage of the trade mark of the competitor in the promo materials. The owning promo material company wants to include the registered information from the competitor's PM. would it be acceptable to use the competitor's registered trademark in the piece? Thank you

Question 624

Wed, 22 Oct 2025 20:45:52 GMT

For an HCP targeted APS, are references required in the final layout of the piece after PAAB approval (i.e., a reference list at the end of the piece and superscripts throughout)? Or do references not need to be included in the layout once PAAB has approved the copy doc? Thanks!

Question 625

Wed, 22 Oct 2025 20:45:50 GMT

For a piece containing TMA dosage forms and dosing instructions, but no therapeutic/pharmacological claims, would low-level balance be sufficient?

Question 626

Wed, 22 Oct 2025 20:45:48 GMT

We have an ongoing pivotal study and would like to report the latest published data. While the data exceeds the duration of that mentioned in the TMA, it is directionally-consistent with respect to magnitude/significance, and no additional safety concerns were identified. Can we report this data in APS, if there is no emphasis placed on the duration?

Question 627

Wed, 22 Oct 2025 20:45:47 GMT

We would like to make non-clinical comparisons between products that are specifically indicated for different subtypes of a disease state (eg. phenotypes of COPD). Would this be acceptable, given the common umbrella disease state?

Question 628

Wed, 22 Oct 2025 20:45:45 GMT

The intent of a pre-launch editorial APS should be to increase health care professional awareness and understanding of a specific therapeutic area, or in this case a specific biomarker. These APS should not contain the message that a new product (or indication) is coming soon as this could be construed as pre-NOC advertising and contravene section C.08.002 of the Food and Drug Regulations. Discussion of how an exogenous compound may modulate a pathway would be rejected as it alludes to a new drug coming to market. Likewise, we would question the message that this biomarker is an emerging target for the disease, this would be construed as pre-NOC advertising. As this APS is targeting HCPs, it should be submitted for PAAB review.

Hi, we have a new product in our pipeline that is currently undergoing an approval process with Health Canada and is targeting a specific biomarker. We would like to do a campaign to HCPs regarding this specific biomarker and to raise the physician's awareness of this biomarker as an emerging target for a particular disease. Is such campaign acceptable, considering that no mechanism of action nor information on the pipeline will be discussed?

Question 628

Question 629

Wed, 22 Oct 2025 20:45:43 GMT

Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks

Question 630

Wed, 22 Oct 2025 20:45:41 GMT

We have a question regarding controlled distribution/gating of a website containing information intended for HCPs. We understand that options for creating an acceptable barrier include "URL of a website which is not indexed" (as presented during Jennifer Carroll's talk "From Email to Virtual Reality" during PAAB's 2017 National Workshop). However, we are unable to find any further information from PAAB or from Health Canada regarding what "not indexed" means in this context. Can you please elaborate, or point us to guidance documentation outlining what "not indexed" means for a site's URL, in order to create an acceptable barrier for the site?

Question 631

Wed, 22 Oct 2025 20:45:39 GMT

We have a Enrollment Form for a PSP program that has been previously approved by PAAB. We have a PDF writeable format which we would like our PSP Field Case Managers ( Nurses) to send to our HCPs via email. Could you please provide any limitations or requirements to this, if any?

Question 633

Wed, 22 Oct 2025 20:45:37 GMT

I would like to send an email to verified healthcare professional, that email would not exceed Price, Name, Quantity, would include no claim and have a deep link to access the product monograph of this schedule A product. Do I need to submit such email to PAAB approval if ... 1- the product monograph is only accessible via this email ? 2- the product monograph is hosted on our corporate website (ungated website) ? 3- the product monograph is hosted on a gated hcp website ?

Question 634

Wed, 22 Oct 2025 20:45:35 GMT

Hi PAAB, If a pharma company who markets a vaccine sponsors a 3rd party vendor for the writing of an independently written article on adult vaccines in which all treatments are discussed and this vendor distributes this article to HCP through their channels is this considered advertising and would the article require PAAB review? The Pharma company would not review the article. If the distribution by the vendor is to consumers does it require pre-clearance by PAAB? Could the sponsorship be identified at the article “This independently written article was sponsored by XYZ Pharma Co”? Given that the topic is vaccination and it is Schedule D, could we link an ASC approved ad with the consumer article as you mention in Question 153? Would this PAAB require pre-clearance? Thank you.

Question 635

Wed, 22 Oct 2025 20:45:34 GMT

For APS having only two surfaces (i.e. a double-sided card), can you confirm if market benefit claims can appear on side 1, with the indication appearing on side 2?

Question 636

Wed, 22 Oct 2025 20:45:32 GMT

Can a claim of "Proven efficacy" appear over a presentation of clinical data, if that data was the basis for the product indication?

Question 637

Wed, 22 Oct 2025 20:45:30 GMT

We are currently embarking on a help seeking announcement for a prescription product. The help seeking message will follow the criteria as outlined in Health Canada's policy, The Distinction Between Advertising and Other Activities. We wish to additionally inform HCP’s of this campaign through promotional systems such as a detail aid to ensure full transparency to the HCP regarding the campaign. • Are we able to identify the help seeking campaign in promotional systems directed to HCPS? • Are we able to include additional promotional product messages in the promotional material? • If not permissible in the same promotional system, are the two allowed in the same sales call?

Question 638

Wed, 22 Oct 2025 20:45:28 GMT

Would the use of a publication for a clinical trial evaluating two different head-to-head treatment comparisons be allowed in promotional materials if only one of the head-to-head comparisons is in alignment with the TMA? More specifically: •The comparison of Product A versus Product B is in alignment with the TMA for Product A i.e, a comparison versus another product in the same therapeutic class as Product B is included in the TMA; the primary endpoint in the publication is the same as a secondary endpoint included in the TMA for a pivotal study; same patient population. •The comparison of Product A versus Product C is not in alignment with the TMA indication for Product A. •Would the comparison of Product A versus Product B be allowed in promotional materials for Product A?

Question 639

Wed, 22 Oct 2025 20:45:27 GMT

Just wondering how long it would take to receive a response to a question submitted through Ask PAAB?

Question 640

Wed, 22 Oct 2025 20:45:25 GMT

Code s6.6(i) states that materials independently prepared with industry involvement limited to sponsorship/distribution are exempt from review. Can you confirm if 3rd party influencer/blogger social media posts are therefore exempt from review, if industry involvement is limited to paid sponsorship?

Question 641

Wed, 22 Oct 2025 20:45:23 GMT

Hi PAAB. Can you advertise a drug to the general public if it is indicated for a condition/disease not listed in schedule A.

Question 642

Wed, 22 Oct 2025 20:45:22 GMT

Is an unbranded conference booth display targeting HCPs, that leverages creative from a help-seeking DTC campaign exempt from review? There is no mention of product or treatment options, just disease info only. However, other APS that are part of the DTC campaign (same branding) do contain mention of treatment options, however in a balanced presentation.

Question 643

Wed, 22 Oct 2025 20:45:20 GMT

If a DTCI Consumer Brochure closes with a 'help-seeking' message, would it still be considered a Consumer Brochure, or would it be reviewed as a Help-Seeking Announcement (or a combination of the two)?

Question 644

Wed, 22 Oct 2025 20:45:18 GMT

Hi, I wanted some clarity on the rule below. Essentially, we are allowed to use peer reviewed resources, etc. to support claims, as long as the claim made references a clinical endpoint already captured in our monograph? Specifically, if my label mentioned confirmed disability worsening, but I also have long term data that discusses confirmed disability improvement (diff metric), I would not be allowed to use this? -- 3.2.2 Literature used to support claims contained in the APS must be consistent with the indications, dosage regimens, and efficacy and safety information contained in the Health Canada TMA.

Question 645

Wed, 22 Oct 2025 20:45:17 GMT

Hello PAAB! Can sales representatives distribute a tool that was approved by PAAB as DTC to physicians to provide to potential patients? Would this tool need to be re-submitted through PAAB as unbranded patient material? Thank you!

Question 646

Wed, 22 Oct 2025 20:45:15 GMT

I recognize that consumer help seeking campaigns cannot disclose the manufacturer's name. In the event of a DTC disease awareness website, that is seeking to allow users to opt in to receive future communications (all unbranded, disease related in nature), we're challenged by CASL regulations which appear to conflict with Health Canada's guidance. CASL regulations indicate the name of the sender must be included. If the sender of the communication is indeed the manufacturer, is the manufacturer's name, allowed for inclusion in the website copy in this circumstance, presumably with minimal prominence in order to solely meet CASL guidance? Or, can you provide examples, guidance, or a recommendation on how a manufacturer may meet CASL and Health Canada guidance in this situation? Thank you.

Question 647

Wed, 22 Oct 2025 20:45:13 GMT

In order to discuss switching patients from Product-A to Product-B within an APS, what is required for substantiation: a specific mention in the TMA/indication, Guideline recommendations, a head-to-head study? Also, does this substantiation need to appear in the APS itself?

Question 648

Wed, 22 Oct 2025 20:45:11 GMT

We have a product indicated for the treatment of 'drug-resistant Condition-X'. Since this disease inherently links to drug therapy, I do not see how we can produce PAAB-exempt disease education materials. Does this seem like a fundamental limitation of the Code (6.6vii)? Could we produce exempt materials describing 'resistant' or 'refractory' Condition-X instead?

Question 649

Wed, 22 Oct 2025 20:45:09 GMT

Our company has an unbranded disease-focused app in the Apple/Google stores. As legally required, the manufacturers name must be disclosed in these stores. Can we make mention of this app in a separate DTCi Help-Seeking campaign (that itself does not mention the sponsor)? The campaign would not focus on the app, but mention it as one of many additional resources.

Question 650

Wed, 22 Oct 2025 20:45:08 GMT

Hi Patrick, I was wondering, after PAAB approves copy. Is it forbidden to make minor typography changes? I.e. spelling mistakes, punctuation, periods. As long the same message is there is that still considered an unsolicited change?

Question 651

Wed, 22 Oct 2025 20:45:06 GMT

If I have two clinical trials in slightly different patient populations, is it acceptable to present data from only one of the trials in an APS? Both populations fall under the same indication.

Question 652

Wed, 22 Oct 2025 20:45:04 GMT

I understand that for international conferences held in Canada the following conditions need to be meet for being exempt for PAAB review according to (Health Canada policy document “The Distinction Between Advertising and Other Activities) I. the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions, II. the material must emanate from the parent company of the manufacturer, III. the material must only be for use within the confines of the conference, and IV. the material is prominently identified as not being authorized for sale in Canada. The question I have is for the use of material that is non-branded and no product specific that makes reference to a therapy area/class for which several products are approved in Canada for sale by the local subsidiary. Would this non-branded, no-product specific material (banner), that talks about a therapy area/class would it be considered PAAB exempt for use at an international conference?

Question 653

Wed, 22 Oct 2025 20:45:03 GMT

Are there any limitations for using Phase II studies as support for therapeutic claims, apart from disclosing the Phase II nature?

Question 654

Wed, 22 Oct 2025 20:45:01 GMT

Dear PAAB, Our Pharmaceutical Company is planning to do a Patient Support Program gated website; we will send this website to PAAB for review. We would like to add links to an independent patient association website that has different resources for patients. If we link to the home page of the patient association, will PAAB need to review the entire website even if we with a disclaimer that they are leaving the company website? Can we link to separate documents (e.g. disease state , treatment options)? In this case does PAAB need to review each document ? Since our website is branded are these going to be reviewed as branded pieces? Thank you.

Question 655

Wed, 22 Oct 2025 20:44:59 GMT

We would like to do a table comparing non-clinical aspects (indication, route of admin, dosing, monitoring, etc.) of various products indicated for a specific disease. There are more than 10 drugs with this indication, so it will contain a lot of information, all of which will be based on the respective product monographs. It is our intention to give each brand equal prominence (i.e., it will not be specifically branded to one drug). What are the balance requirements for a piece like this? Normally, we understand that dosing warrants high-level balance. However, we can't possibly fit high-level balance for all of the product that will be mentioned in this piece. What do you suggest? Thank you!

Question 656

Wed, 22 Oct 2025 20:44:57 GMT

In a DTC Consumer Brochure discussing treatment options for a given disease, can narcotic treatments be included in a balanced list of treatment options? We are assuming a Consumer Brochure is not defined as advertising under the Narcotic Control Regulations s70.

Question 657

Wed, 22 Oct 2025 20:44:56 GMT

I'm working on building an app for a pharma client. It's a companion for a drug they market. But I'm concerned that the review section in the App Store will put us at risk of being non-compliant. Do you have any suggestions to help?

Question 658

Wed, 22 Oct 2025 20:44:54 GMT

Are there any circumstances under which data from a reference arm could be included in an APS?

Question 659

Wed, 22 Oct 2025 20:44:53 GMT

As per the PAAB Code section 1.8 Definitions, the New Healthcare Product is defined as follow: "Any prescription or non-prescription product manufactured and/or marketed in Canada by a particular company for a period of less than 2 years". It is our understanding that for any APS we are limited to one year of usage of the word "New" from initial marketing. However, please clarify, what is the less than two years period in the above statement for the “New Healthcare Product" is referring to?

Question 660

Wed, 22 Oct 2025 20:44:51 GMT

A IMC Member is questioning their obligation to submit slides to PAAB under the IMC Code Section 9.6 which states: "9.6 Speaker Training (Faculty Training) and Workshops 9.6.1 General Principle 9.6.1.1 For learning programs, irrespective of the format, on new products, new indications or disease state or significant label changes (i.e. patient safety), a need may arise to train an appropriate number of Health Care Professionals who are recognized experts on this information so as that they may disseminate this information to their colleagues for the benefit of Canadian patients. A product or indication is considered “new” up to one year after its initial marketing. " Assuming we are referring to a new drug or new indication. If the slides for these programs are developed by a scientific committee consisting of HCPs and the slides are then presented by HCPs to other HCPs - do these slides require PAAB approval since they make reference to a specific drug/use?

Question 661

Wed, 22 Oct 2025 20:44:49 GMT

In an HTML email, does the layout need to include the full product monograph address i.e. www.Bestpharma.greatdrug.ca/pm.En , or can it just read click here for Product Monograph. The word 'here' would be bolded and link directly to the unmodified PM. Please let me know.

Question 662

Wed, 22 Oct 2025 20:44:46 GMT

Hi Patrick, I have the following question: When using the terms "proven efficacy" in a headline in the context of what the product is indicated for, why do we need high level fair balance? For example, "Product X has proven efficacy in the treatment of Arthritis." If the product has received an indication for the treatment of arthritis, it has been shown to be effective - otherwise it would not have received such an indication. So, this headline is simply a factual statement, as opposed to a clinical claim. Thanks in advance for your clarification.

Question 663

Wed, 22 Oct 2025 20:44:45 GMT

Can baseline patient demographics (not outcomes) captured by Patient Support Program enrollment be used in HCP-directed advertising, in a promotional or claim-neutral manner?

Question 664

Wed, 22 Oct 2025 20:44:42 GMT

In the "other relevant warnings and precautions" section of the highest-level fair balance, is there a requirement to include warning/precautions about effects that were not systematically studied/evaluated and that are not class warnings. Here is an examples of what I suspect needs to be included: bullet point " seizures" if PM has "seizures" bolded followed by "xxx has not been systematically evaluated in patients with a seizure disorder. Patients with a history of seizures were excluded from clinical studies. Seizures are a potential risk with antidepressant drugs. xxx should be prescribed with caution in patients with a seizure disorder." Here is an example of what I suspect does not need to included: bullet point "cognitive and motor disturbances" if PM has "cognitive and motor disturbances" bolded followed by "The effects of xxx on the ability to drive or to operate machinery were not systematically evaluated in the xxx development program." Please advice if my assumption is correct. Thank you.

Question 665

Wed, 22 Oct 2025 20:44:41 GMT

We would like to produce a non-branded APS that highlights the current medical practice on using a specific class of medication. The most recent Canadian consensus guidelines (updated in 2017) support the message that this class of medication should now be offered as an option to patients undergoing continued maintenance treatment (this is a big change vs the last consensus guidelines publication from 2003). 2 Questions: 1) We assume it would be acceptable to make a claim in an APS that outlines this recommendation, given that this is from an approved, authoritative source, correct? 2) This guideline document also provides context around why their position has changed. They provide details about how this class of medication was used historically, and also outline some of the evidence that supports their new recommendation, which included reviewing 3 RCTs among other sources (note: they communicate that there is data that supports the classes superiority, but also data that challenges it). Would it be permissible to also include a balanced presentation of these additional details in our APS? If not, why? Wouldn't a consensus guidelines document be an acceptable reprint that a company sales rep could distribute to HCPs? And if so, then why would be ok for them to distribute the document that includes this information, but it wouldn't be permitted to use the content on its own in an unbranded APS if referenced accordingly and presented in a balanced and objective manner?

Question 666

Wed, 22 Oct 2025 20:44:39 GMT

Is it possible to make a “#1 reccommended” brand claim? If so, what support would be required?

Question 667

Wed, 22 Oct 2025 20:44:37 GMT

We have a non-prescription drug and we plan to leave coupons for patients in the doctors' offices. Do the coupons need to be PAAB approved?

Question 668

Wed, 22 Oct 2025 20:44:36 GMT

We will be offering OTC product samples through a third party sampling program. In the order brochure there will be a pack shot of the sample pack, brand name and dosing. Does this need to be PAAB approved?

Question 669

Wed, 22 Oct 2025 20:44:34 GMT

If you are creating a corporate APS in a print format that lists a pharmaceutical company's products, do you also need to include some level of fair balance for those products?

Question 671

Wed, 22 Oct 2025 20:44:32 GMT

It seems that materials that cite a product is available through the Special Access Program would be considered promotional. Are these types of materials reviewed and approved by PAAB, or are they strictly prohibited as alluded to in the Health Canada Guidance regarding special access programs? Without some notice, I don’t know how healthcare professionals know whether a product is available through SAP.

Question 672

Wed, 22 Oct 2025 20:44:30 GMT

Would materials used to train Healthcare professionals prior to using a product be items to be reviewed by PAAB, or do they reflect more Continuing education materials? The trainings would be done on site by medical science liaisons.

Question 673

Wed, 22 Oct 2025 20:44:29 GMT

A company has a product approved in the US. They have a booth at a Canadian convention. Can the company distribute product specific materials in the 'international' section of the booth as long they are in line with FDA approved label? If so, do these materials need to be reviewed/approved by PAAB too?

Question 674

Wed, 22 Oct 2025 20:44:27 GMT

Is it acceptable to compare the clinical trial inclusion/exclusion criteria among competitor products? We would like to make the point that patients with certain conditions were included in the trials for 1 product but not in trials for its competitors. I understand non-clinical information can be compared across products, and we wondered if inclusion/exclusion info was considered clinical or non-clinical. Could this be done in a branded context?

Question 675

Wed, 22 Oct 2025 20:44:25 GMT

We run a website that contain unbranded disease awareness information as well as unbranded drug information. Are we permitted to leverage our website to run targeted ads that link to sponsored DIN-gated sites?

Question 676

Wed, 22 Oct 2025 20:44:23 GMT

Hi Patrick - Would you be able to explain the rationale behind Code s3.7, and why combination products cannot reference the brand names of their individual components (only the generic names)?

Question 677

Wed, 22 Oct 2025 20:44:22 GMT

We have a situation where previously-approved clinical data in our TMA has been removed. This was an editorial request from Health Canada, simply to make room for new content (as Health Canada often requests trade-offs in order to keep TMAs succinct). It does not reflect a change in approval of the data itself. Therefore, can you advise if this previously-approved TMA data can continue to be used in APS? Note, the data does not appear in published studies and is therefore considered Data on File.

Question 678

Wed, 22 Oct 2025 20:44:20 GMT

We understand that a 'Made in Canada' claim can be made for a drug manufactured in Canada. Would the same be true for a drug first discovered in Canada (ie. 'Discovered in Canada')?

Question 679

Wed, 22 Oct 2025 20:44:18 GMT

In the fair balance when we direct customers to a site for the Product Monograph, should we direct them to the Health Canada Drug Database page or to our corporate page with the monograph? We have concerns with directing them to the Health Canada page as they do not always post the most up to date version of the Product Monograph or sometimes the French version is not available.

Question 680

Wed, 22 Oct 2025 20:44:16 GMT

Is the PAAB code applicable to the advertising of veterinary medicines? thanks!

Question 681

Wed, 22 Oct 2025 20:44:15 GMT

Hi, at an international conference to be held in Canada, there will be a large presence from our parent company (US company), as well as some presence from our local affiliate (i.e. Canadian office). Our product is approved in both US and Canada. Our US counterparts have a booth graphic that has information based on the USPI (i.e indication as well as claims). These are not completely aligned. Is the booth with US information acceptable at this conference? (This booth will be shared by US and Canadian colleagues). Also, can the US promotional materials be handed out or does the information need to only align with the Canadian PM? And finally, can the USPI as well as the Canadian PM for this product be handed out at the conference? Thank you!

Question 682

Wed, 22 Oct 2025 20:44:13 GMT

If we create a survey asking about the impact of using intravenous vs. subcutaneous drugs on clinic/hospital resources (personnel, time, money) - and we don't mention the therapeutic area, disease state or a specific drug (neither brand nor non-proprietary name will be mentioned), would this survey be exempt from PAAB pre-clearance?

Question 683

Wed, 22 Oct 2025 20:44:11 GMT

Hi Patrick I've been told that vaccines fall under different promotional guidelines than other prescription medicines. We are putting together a now available pharmacy fax for our soon to be promoted vaccine and wanted to confirm if we need PAAB approval on this or not. The communication would include the brand name, logo, indication, price, DIN and product number. It would also include corporate trademarks. Thanks

Question 684

Wed, 22 Oct 2025 20:44:10 GMT

When two companies are co-promoting a product and using the same material approved by PAAB, are the promotional materials required to display both company names and/or logos or can the material have one company name and log and still be used by both companies?

Question 685

Wed, 22 Oct 2025 20:44:08 GMT

Does the PAAB have criteria when it comes to determining acceptability of high-quality meta analyses, with respect to clinical claims?

Question 686

Wed, 22 Oct 2025 20:44:06 GMT

If we want to create an email invite which links to a promotional branded webinar (paab approved), do we have to submit the invite to paab (if the invitation itself has only name of product, time, date & link for registration)?

Question 687

Wed, 22 Oct 2025 20:44:04 GMT

Regarding teaching tools (slides, desktop tool) used by HCPs to educate patients: Is it possible to include efficacy information in a piece to be used by HCPs with patients, recognizing it would be a clinic-based tool and not something taken away by the patient? Is there a regulation or code that prohibits HCPs from educating patients about efficacy results? Is there any resource that explains why this information is not included in part 3 of the Product Monograph?

Question 689

Wed, 22 Oct 2025 20:44:03 GMT

Question 690

Wed, 22 Oct 2025 20:44:01 GMT

On what basis (code?) should a DTC magazine ad be prepared for a nonprescription drug product that is sold to the general public with the intervention of a healthcare professional ("ethical" drugs)? Secondly, should such DTC material be reviewed by PAAB or or by Ad Standard Council of Canada?

Question 691

Wed, 22 Oct 2025 20:44:00 GMT

With regards to the PAAB-exempt regulations, and the requirement to not link to product information - can you confirm if the definition of linkage is in the language used in the piece? For example, if you had a webinar invitation that had only the product name (no indication, disease information, etc) however that invitation was inviting someone (via website link) to a webinar/registration page etc that was all PAAB reviewed/approved, is the invitation still PAAB exempt or by virtue of having a weblink (or intention to direct to PAAB-approved material if it were paper copies etc), is the invitation now in scope of PAAB review?

Question 692

Wed, 22 Oct 2025 20:43:58 GMT

In DTC would non-medical devices (i.e. Breezhaler/Respimat/Ellipta) be associated with their drugs immediately? As such be limited to the name, price and quantity in terms of messaging or would there be leeway to talk about device features in a comparative standpoint or would that be against the code?

Question 693

Wed, 22 Oct 2025 20:43:57 GMT

Is a non-medical device associated with a drug be recognized as a therapeutic product regardless of whether the ad in question contains information about the drug itself in a direct to consumer standpoint?

Question 696

Wed, 22 Oct 2025 20:43:55 GMT

We have a study we would like to use to support a claim in a new tool. In this study “DRUG B” is used as an add-on to our product, whereas in our product monograph our indication is stated as an add-on to “DRUG B”. Would this be an issue?

Question 697

Wed, 22 Oct 2025 20:43:53 GMT

I have read the HC Policy 'Distinction between advertising...' for Press Release (PR). However I see many PR online that go beyond simply stating name and therapeutic area. Many PR mention efficacy and safety data. Am I misinterpreting the HC policy or can we in fact speak to the degree of efficacy and safety in a PR?

Question 698

Wed, 22 Oct 2025 20:43:52 GMT

Could you clarify a few points for us: 1 - Is a product indication (verbatim from the product monograph) seen as a claim by PAAB? 2 - If a detail piece, journal ad etc., contains only branding colours, brand name and product indication, does PAAB need to review this or is it exempt? 3 - Per question 2 above, if the piece also contains imagery related to the indication, does that change the PAAB review requirement? Thanks for the clarification.

Question 699

Wed, 22 Oct 2025 20:43:50 GMT

A pharma company wishes to produce an Unbranded video that will be used by reps for a call with HCPs. The video will feature a patient campaign that has already been approved by PAAB. There are no claims being made in the video, and it just provides an emotional story behind the campaign. Would this be considered PAAB exempt?

Question 700

Wed, 22 Oct 2025 20:43:48 GMT

Can we present two different brands, (which are two different therapeutic areas) in one APS (i.e. in a LB) as long as the indication and balancing info is presented for both brands?

Question 701

Wed, 22 Oct 2025 20:43:46 GMT

Can HCP advertising and Patient advertising (not consumer) feature the same campaign visual, design and statement, with the understanding that the information within the campaign is in context for each audience. (Patient information driven from Part III of the PM)?

Question 702

Wed, 22 Oct 2025 20:43:44 GMT

Hello, If we are temporarily suspending a website while we update the contact (as the website's current content is set to expire), do we need to PAAB this temporary page? Or since there is not claims and no other pages can be accessed this step is unnecessary? Thanks

Question 703

Wed, 22 Oct 2025 20:43:42 GMT

Regarding the PAAB Guidance document "Tips relating to inclusion of expert commentary in drug advertising", would the same rationale and requirements apply to patient testimonials?

Question 704

Wed, 22 Oct 2025 20:43:41 GMT

If a product has two possible dosing schedules, with no specific requirements/recommendations on which HCPs can choose, are we permitted to just focus on one dosing schedule in APS? If both dosing schedules are required, are we permitted to focus on one over the other in terms of prominence?

Question 705

Wed, 22 Oct 2025 20:43:39 GMT

Can a non promotional website that is not subject to review and is only available to verified Canadian HCPs link to a post-gate landing page for a PAAB approved branded website?

Question 706

Wed, 22 Oct 2025 20:43:37 GMT

Can sales representatives provide information on a drug's reimbursement criteria in response to a question from a HCP if the reimbursement criteria are not aligned with the TMA. For example, the approved Health Canada indication is for use as 2nd line therapy but the drug is only reimbursed for use in 3rd line. Could the sales representative respond to the question and provide information on reimbursement if not aligned with the TMA. Thank you.

Question 707

Wed, 22 Oct 2025 20:43:36 GMT

Hi, For the balance copy requiring a direct link to the Product Monograph - the guidelines state that a link to the Health Canada database along with DIN number would work in lieu of a corporate URL. If going this route, is it sufficient to say: "Search the Health Canada Drug Product Database and search DIN XXX for...." OR must the database URL be written out? It is quite long: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) Much thanks!

Question 708

Wed, 22 Oct 2025 20:43:34 GMT

If Product-A is a combination of Drug-B and Drug-C, can the mechanism of action information from the Drug-B and Drug-C Product Monographs be used in Product-A advertising? The Product Monographs for combination products usually contain less information regarding their components (for brevity), however mechanisms of action should be identical regardless of formulation.

Question 709

Wed, 22 Oct 2025 20:43:33 GMT

For a product with two different administration formats (eg. syringe and pen), is it permissible to only advertise one format in APS (with no mention of the other device)?

Question 710

Wed, 22 Oct 2025 20:43:31 GMT

For Help-Seeking Announcements, the Distinction Between Advertising and Other Activities states "there is no implication that a drug is the sole treatment available". Does this mean no implication for a single brand within the context of available drug treatments, or no implication for drug treatment over non-drug treatment?

Question 711

Wed, 22 Oct 2025 20:43:29 GMT

Can patient survey data from CADTH be used for an unbranded tool on current patient experience and behaviour?

Question 712

Wed, 22 Oct 2025 20:43:28 GMT

We have an online newsletter where we post healthcare-related information, as well as society news pertaining to our association. Our member and supporter base primarily consists of hospital pharmacists as well as a small number of architects, students, and pharmaceutical companies. We can set-up advertising on the site to require a login to limit access by the general public. My concern is with the students who are not yet healthcare professionals, the pharmaceutical organizations, and the small number of architect members. Would their exposure to pharmaceutical advertising go against PAAB standards, even if we include a disclaimer that the advertisements are meant for healthcare professionals only? When we used to have a print journal that contained advertising for pharmaceutical products, the same individuals would have received copies of it. To my knowledge, this was not an issue in the past. However, we would appreciate some guidance to ensure we are being PAAB compliant, as online advertising is new to our association. Thank you kindly.

Question 713

Wed, 22 Oct 2025 20:43:26 GMT

Can ongoing studies for a group of products (same therapeutic category) be discussed in a Corporate APS, or must this be done in individual branded APS? For example, a company has a portfolio of diabetes drugs that with ongoing research into weight loss indications, and would like to produce a single piece discussing all trials.

Question 714

Wed, 22 Oct 2025 20:43:24 GMT

If a representative during a social meal mentions to an HCP a reference to a slide that was viewed at another meeting to HCP's with regards to utilization rates of a genericized molecule, is this considered a violation?

Question 715

Wed, 22 Oct 2025 20:43:23 GMT

Hi, I'm from the Arthritis Society. I have a company that is currently developing a product; in phase 2. They want to support/sponsor one of our tool in a field that is relevant to their upcoming indication. Content and material will be elaborate by the Society without any interference by the pharma company. Would that interfere with any regulation in Canada. If so, which one? Thanks Ken Gagnon kgagnon@arthritis.ca

Question 716

Wed, 22 Oct 2025 20:43:21 GMT

Hello, I'm looking for where to find guidance regarding regulations for executing a 'help seeking' DTC campaign for vaccines at the same time as a branded DTC vaccine campaign. Given the DTC nature, pre-clearance would likely be through ASC. I've reviewed the guidance from Health Canada at length and am well aware of the criteria for help seeking. My understanding is that the help seeking and branded campaigns must be different (ie: in colour, tag lines etc) and not linked in any way, but I'm unable to find specific direction. I'd like to be more clear on how the campaigns must be different, assuming they are not linked in anyway (visually or otherwise), and if/how they may be executed concurrently. ie: can a vaccine help seeking TV ad be on during the same time a vaccines DTC branded banner ad or social media campaign is running (again, assuming not linked in any way). Thank you in advance for your assistance.

Question 717

Wed, 22 Oct 2025 20:43:19 GMT

How can I access archival copies of the PAAB Code? I am looking for the version relevant to 1996. Many thanks.

Question 718

Wed, 22 Oct 2025 20:43:17 GMT

If a efile was previously exempted and no changes were made, does the file need to go through PAAB assessment again (re-exemption)?

Question 719

Wed, 22 Oct 2025 20:43:16 GMT

With regards to question #645, the question asked about repurposing a piece approved for DTC use with "potential patients". Is a potential patient not viewed as a consumer? I thought the definition of patient was restricted to those who had already been prescribed a drug. I had previously been advised by a PAAB reviewer that pieces for "potential patients" would be reviewed as DTC. Could you please clarify the differences in these audiences? Thank you.

Question 720

Wed, 22 Oct 2025 20:43:14 GMT

What are the rules regarding using similar graphic symbols for branded PAAB approved promotional pieces addressed to HCPs and branded DTC materials for the same OTC product. Is it acceptable that they have the same graphic elements such as icons to illustrate the approved claims/indications?

Question 721

Wed, 22 Oct 2025 20:43:13 GMT

Can a patient survey be used to support claims of ease of use? Would it make a difference if the prescription product were administered through a Class-II medical device?

Question 722

Wed, 22 Oct 2025 20:43:11 GMT

Understanding that Help-Seeking messages can not include the sponsor, what if a message was broad enough not to allude to a single product? eg. “Ask your doctor about CV medications from Company-X”.

Question 724

Wed, 22 Oct 2025 20:43:09 GMT

We have an HCP piece approved by PAAB to be used as a print Leave-Behind. We would like to use a part of the content (unchanged) for a digital advertisement. Does is require to be submitted to PAAB as a new file?

Question 728

Wed, 22 Oct 2025 20:43:07 GMT

Hi Patrick - I've read the 2019 Client Survey report on the PAAB website. Is there a plan to disseminate this more broadly, and what actions is the PAAB taking with regards to any of the specific survey results? Thank you.

Question 729

Wed, 22 Oct 2025 20:43:06 GMT

Can you please confirm that use of a drug name along with its pharmacologic classification (eg. 'diuretic') is exempt from PAAB review? The therapeutic classification (eg. 'antihypertensive') would not be included, as this alludes to therapeutic use.

Question 730

Wed, 22 Oct 2025 20:43:04 GMT

Hi Patrick, I have a question related to providing PAAB training. I remember few years ago you came to our company and you provided training. There have been many changes since then and I was wondering if you are still providing similar training. What is the cost associated with this type of activity?

Question 731

Wed, 22 Oct 2025 20:43:03 GMT

Is the PAAB logo required to appear on HCP advertising or patient information approved by PAAB.

Question 732

Wed, 22 Oct 2025 20:43:01 GMT

Is this "Ask PAAB" still active? We have submitted queries 4-weeks ago and did not see any responses? Could you please provide an update?

Question 733

Wed, 22 Oct 2025 20:42:59 GMT

Is it voluntary to get promotional materials approved and simply acts as a benefit to the product or is it this process mandatory?

Question 734

Wed, 22 Oct 2025 20:42:58 GMT

In a company sponsored presentation, can a physician talk about off-label for another drug (not the sponsors drug) e.g. "In my practice I use Drug X to treat nausea", but Drug X is not indicated for nausea

Question 735

Wed, 22 Oct 2025 20:42:56 GMT

Hello, If we want to do a video about the Mode of action of a drug, apart from the PM, what other references can we use?

Question 736

Wed, 22 Oct 2025 20:42:54 GMT

We're developing a pull-up banner and the amount of Fair Balance is not allowing for space for the message. Could we apply the principles allowed for journal ads? Specifically, have medium fair balance on the pull-up banner and direct the reader to a handout adjacent to the panel with the full fair balance?

Question 737

Wed, 22 Oct 2025 20:42:53 GMT

Hello, We would like to know if PAAB would accept the following tool: A desk-calendar for HCPs to use as a counselling tool for when they are scheduling the next dose of a vaccine. It would also feature facts about the disease and best practice tips. Thank you

Question 738

Wed, 22 Oct 2025 20:42:51 GMT

Would it be acceptable to use an image in a patient support material (PSP) if the same image is being used in healthcare professional branded material? The product only has one indication and PSP material would specifically be distributed to patients prescribed the product for the approved indication.

Question 740

Wed, 22 Oct 2025 20:42:49 GMT

A message of “new indication” would be promotional (promotes the feature of a product) and incomplete (what is the new indication). This is not considered an exempt message. Please see PAAB section 1.5 for exempt messages. A message similar to “new data within the TMA” is also a promotional claim and does not fall under the exemption criteria.

Question 741

Wed, 22 Oct 2025 20:42:47 GMT

Do OTC product materials require PAAB review? Does this change if they are rep delivered materials vs online (or other multi-channel mediums not driven by sales resp)?

Question 742

Wed, 22 Oct 2025 20:42:46 GMT

My client is preparing an HCP website that will include brand promotion as well as offer samples. The site will be 'gated' which will involve a landing page that asks the viewer if they are a Canadian physician and require that they input their license number. Does the website require a validation process to ensure that the license numbers and the physician name are accurate? Could the 'validation' be limited to ensuring that the correct number of digits/letters are input (as opposed to confirming that those numbers match to a licensed physician). I look forward to your feedback. Thank you! LC

Question 743

Wed, 22 Oct 2025 20:42:44 GMT

Hi PAAB, I was wondering if expert guidelines for treatment option algorithms (first line, second line) are allowed to be included in branded pieces directed at HCPs. The goal would not be to compare treatments but to see under which situations / for what patients a therapy would be preferred. (Patient profile?) Thanks for your help!

Question 744

Wed, 22 Oct 2025 20:42:42 GMT

Change in Product Ownership - if Company A divests Product X to Company B, can Company B continue to use promotional material for Product X that was previously approved by PAAB for Company A during the DIN transfer, or only post-DIN transfer? If so, can it be used until the renewal date?

Question 745

Wed, 22 Oct 2025 20:42:41 GMT

We have an 8 page print leave-behind detail aid that includes full dosing information. We are thinking of redoing this tool with a half page sized tear off flap that has key reminder information on the dosing. Does this flap have to contain all of the dosing information, or can it just contain e.g., the steps and an example calculation. Thanks.

Question 746

Wed, 22 Oct 2025 20:42:39 GMT

Can HCP branded materials and Patient branded materials utilize the same creative? If not, how different must the 2 be? What elements (colours, key features) can be shared between the two campaigns?

Question 747

Wed, 22 Oct 2025 20:42:37 GMT

Can branded DTC advertising include a claim of 'new' or 'now available'?

Question 748

Wed, 22 Oct 2025 20:42:35 GMT

Hello what kind of references are required to make a claim about number of patients treated with drug/device X worldwide? and about availability in x number of countries? Does Data on file suffice? if not what other references would be expected to approve this claim?

Question 749

Wed, 22 Oct 2025 20:42:34 GMT

We would like to disseminate a branded dosing app to HCPs via the Apple/Google stores. Since app stores are open to the public, is this possible if (A) the app description/screenshots are limited to name-only and (B) the app reviews are disabled? The app itself would be password protected, so could only be opened by HCPs (consumers could download the app but not open it).

Question 750

Wed, 22 Oct 2025 20:42:32 GMT

We are creating a gated patient website that will show clinics near the patient's location. After initial PAAB approval, is it possible to continue to update the list of available nearby clinics as they open/close/move? Or are those updates subject to PAAB approval again, even if it is within the approved year?

Question 752

Wed, 22 Oct 2025 20:42:30 GMT

Hi PAAB, I was reviewing my brands promotional pieces that will need to either be updated or be sent for rePAAB over the next few months. Since some of the pieces were approved, we have had a product monograph update. However, for certain pieces it does not change the Terms of Market Authorization and in some cases the copy in the piece wouldn't need to be changed. The only part of the piece which would need to be changed is the date of the Product Monograph (e.g. brochure) within the references. Since we have significant print inventory, is it permissible to have these submitted as a rePAAB to be valid for the next year until the next update or rePAAB without updating the date of the product monograph within the piece? Please advise. Many thanks.

Question 753

Wed, 22 Oct 2025 20:42:29 GMT

My question is in regards to PIS (Product Information Session) invite templates, Is there any restriction in our reps sending via email an invite to an HCP which has free text specifically to include the date, time, location and speaker. Thanks so much

Question 754

Wed, 22 Oct 2025 20:42:27 GMT

We are looking to develop a corporate email that would be sent by the reps to outline the opportunity to communicate virtually with them. The layout would be corporate branded with no mention of any brands. The content simply outlines the benefits of a virtual call and how to connect/steps to make a video call. Would this type of information be exempt from PAAB review?

Question 755

Wed, 22 Oct 2025 20:42:26 GMT

I’ve reviewed your forum and website but my colleagues and I still have varying views. If a product receives Health Canada NOC, may an employee in a sales role email an HCP with this information with no efficacy claims? Would an employee in a medical affairs position be able to send same email? Is there a difference in who may send communication? Thank you.

Question 756

Wed, 22 Oct 2025 20:42:24 GMT

If I am developing a patient brochure for a medication, I know I am restricted to Part 3 of the PM. However, structurally, am I able to flow content in a way that is more digestible and clear to the patient - or am I subject to the structure Part 3 lays out? I find the content jumps all around and is very challenging to follow, and I am looking to restructure so that the flow is more friendly from a patient information consumption perspective. Everything will be referenced to Part 3 as required. Is this ok?

Question 757

Wed, 22 Oct 2025 20:42:22 GMT

My question is specifically regarding a sales rep emailing a (known, consented) HCP one on one with: A) A one line message that a product has now received Health Canada approval with approved indication. No claims, data etc B) A request to HCP to discuss Patient Support Program which may include info on the PAAB approved patient enrolment form Is this communication different if a Medical Affairs staff member sends the email? thanks very much.

Question 758

Wed, 22 Oct 2025 20:42:21 GMT

In the PAAB Fair Balance guidance, for lowest level FB, it states "messages which do not relate to the healthcare product (e.g. disease information)". Question is: If the message does not relate to the product and only disease info, why would we require any FB at all? it is not advertising. Or could you provide an example for this scenario?

Question 759

Wed, 22 Oct 2025 20:42:19 GMT

We want to develop an unbranded, ungated website that we plan to send to ASC. The content is about adherence and as such is appropriate for all audiences. Can we develop unbranded promotional tools, like banner ads on NEJM, that direct HCPs to this site?

Question 760

Wed, 22 Oct 2025 20:42:18 GMT

What type of gating is required for a HCP website for a schedule 1 product (narcotic)? is de-indexing considered a form of gating? What type of information can be available pre-gate? can information around a patient support program be made available pre-gate for a schedule 1 (narcotic) product?

Question 761

Wed, 22 Oct 2025 20:42:16 GMT

Can a company website that contains Health Canada approved product monographs also contain brand logos and product photos? The website is not gated and publicly available.

Question 762

Wed, 22 Oct 2025 20:42:15 GMT

I am interested in the safety data for one of the products. Can i use data from a pooled analysis of 10 clinical trials (same indication and product) in our marketing materials. It contains data from pivot clinical trials as well. Can it be considered as a meta-analysis?

Question 763

Wed, 22 Oct 2025 20:42:13 GMT

When and why was the following removed from the PAAB code? Disease information materials which make no mention of treatment by name, class, or category AND are not linked to healthcare product advertising in any way, are exempt from PAAB preclearance. Does it not still apply?

Question 764

Wed, 22 Oct 2025 20:42:11 GMT

Dear PAAB, Can we have an email (APS sent to HCPs) linking to a patient support program provider's (3rd party) website or patient association website? Thank you.

Question 767

Wed, 22 Oct 2025 20:42:09 GMT

It is not uncommon for employees in a sales or marketing function to have the name of the product they support in their email signatures. If such an employee sends an email to a HCP and attaches materials that are not specific to a product (i.e. unbranded disease related) does that attachment now become an APS and therefore subject to PAAB review due to its association to the product name in the email signature?