You're Invited: CASL Compliance for Pharma Companies - Where Are We Now?CASL Compliance for Pharma Companies - Where Are We Now Presentation.
Wanna see what’s cooking? Prepare your advertising with review tips and cases hot off the PAAB grill.
In response to requests from our clients, PAAB will be adding review tips and review cases on an ongoing basis to our website. Click here to see the most recent entry. A new entry will be added every month. These are formulated specifically to address current submission trends or key issues. Come see the hot topic of the month and come back next month!
Extension Request Form
Dear PAAB Clients,
Please take note of this important advisory about approval extensions.
Section 8.4.iii of the PAAB code states:
Under special circumstances, e.g. adjustment to a new 12 month advertising schedule or a delay in production of new material, the Commissioner may extend the PAAB clearance beyond the 12-month period. Extensions at no fee charge shall be restricted to no longer than two (2) consecutive months. Longer extensions shall be subject to the full fee applicable to the particular type of advertisement.
The new PAAB code was implemented on July 1, 2013. During the transition period which followed, the PAAB has been providing, on a case by case basis, extensions beyond the 2 month period to accommodate clients as they transition to the new code. As you know, we are nearing the end of the 1 year transition period. Therefore, effective immediately, extensions at no fee charge shall be restricted to no longer than two (2) consecutive months per PAAB code section 8.4.iii. Note that extensions are only provided under special circumstances.
All extension requests can be emailed to firstname.lastname@example.org with a completed Extension Request Form for each product; see attached. If you have any questions, please feel free to contact the PAAB office.
Annual General Meeting - April 24, 2015
General Meeting - June 19, 2015
General Meeting - September 25, 2015
General Meeting - November 27, 2015
Record of Discussions
New eFiles System Webinar Q&A
Below are some questions and answers from the recent PAAB Submission Approval System Webinar series.
Q. Can you confirm when the new efile system will go live before end of training?
A. We anticipate launching the new efile system within the next few weeks. Target is to be live on April 14th
Q. Will prior submissions be migrated to the new system?
A. Yes, prior submission will be migrated to the new system and will maintain their current efile #.
Q. Will there be a user guide provided once the new system is up and running?
A. There will be a help video posted to the Homepage of the new efiles system which will demonstrate the functions used in the system.
Q. What are the acceptable browsers which support the new Efiles system?
A. The new system requires a modern browser such as Chrome Firefox, Safari or Internet Explorer version 9 or higher.
Q. Are there any special IT or system’s set up to be completed prior to being able to use the new system?
Q. Does your login and password change when moving to the new efile system?
A. Your login and password will be migrated to the new system. However, for security reasons, you will be prompted to reset your password the first time you access the new system only.
Q. Will the system show that invoices are paid? Will they be stamped?
A. No, the new efiles system will not show that invoices are paid and will not be stamped.
Q. In terms of invoicing, if additional documents are required for submission (example annotated PM), is that still a single submission?
A. If while processing a submitted file, it is determined that a document is missing, the file will be returned to the client to upload the missing document and resubmission of the file as a first submission. This is still a single submission and does not affect the invoicing process.
Q. Will invoices still be sent via email, or are they only accessible in eFiles now?
A. Invoices will continue to be emailed to the Client’s accounting contact currently listed with PAAB and they are listed on the actual Efile now.
Q. Now that we can access invoices will they still be sent to the agency regardless?
A. Yes, the PAAB will continue with the current practice of emailing invoices and they are available to our clients, under the ‘Invoices’ tab with each respective efile. You do not need to retrieve them for billing purposes.
Q. Will the invoices continue to be sent to the accounts payable instead?
A. Invoices will continue to be emailed to whomever is listed as the Client contact to receive the company’s invoices.
Q. Do all documents have to be in PDF?
A. Other than video files, all documents must be in PDF format
Q. Can you advise if a Cover Letter is required for Renewal submissions?
A. Yes, a Cover Letter is required for every submission submitted to PAAB. We ask that all submission details be included in a Cover Letter rather than placing them in the ‘Notes Field’. The ‘Notes Field’ should be used for short notations and will allow a maximum of 300 characters.
Q. Do we need to input author and source material like how it is done now?
A. Yes, Author, Title and Source fields are required to be filled in the new Efiles system, as well as the Month and Year of a Source. This will facilitate the saving and filing of your documents in our Efiles library for future use.
Q. How many backups can be assigned in the new system?
A. Two backups may be assigned to each eFile in the new system.
Q. Is the 'dashboard' advertised previously still part of this new website?
A. Yes, the dashboard with statistics will be available as part of this new system.
Q. Should copydecks still be in PDF format, or are other formats now supported (MS Word, etc)
A. Yes, other than video files, all documents will need to be uploaded to the new Efile system in PDF format.
Q. What are the 3 buttons/features in the upper-right corner?
A. The # button indicates unread notifications. Click to view them. The Gear is for Managing your profile. The Person button displays your login credentials and allow you to logout.
Q. What is the 'Progress' bar supposed to indicate?
A. The ‘Progress’ bar is a visual representation of the timeline associated with a particular file. A newly submitted Efile will indicate Green, change to Yellow as the file ages, and then to Red as the due date is approached.
Q. for References, is it necessary to specify the exact publication date? Or can we just put the first of the month that the reference was published
A. The month and year of a publication date is all that is required to satisfy the Publication Date field logic.
Q. If you mistakenly uploaded the wrong document, is there a way to delete before you submit?
A. Yes, you always have the option to delete a document from an Efile before you submit the file to PAAB.
Q. Will we be able to see our submission statistics?
A. Yes, the dashboard will display your submission statistics
Q. During response submissions, if we upload a file and then realize it is the wrong file (without hitting submit), can we delete it, or are we still required to email/call PAAB to remove the file?
A. For New and Revision submissions, you will have the opportunity to delete files prior to submitting or resubmitting back to PAAB.
Q. Once a reference is uploaded, it will be placed into a database to avoid having to re-upload it again for similar submissions. Can you further explain?
A. While uploading a new reference to the new system, you will be required to input the Author, Title, Publication Source and Publication Date (mmm/yy). You also have the opportunity to give a ‘Friendly Name’ to each file. You will have the ability to search for a previously uploaded file from within your company library on the Efile system, using the file name information. When retrieving this same file for reuse, you simply search and locate the file and drag and drop it from the library to the Resource drop area of the new efile. Please Note: Annotations made to the originally uploaded document are saved in the document file. If annotations will differ for the new Efile document, a new document should be uploaded to the efile. Reuse of an annotated Product Monograph would be an example of a reusable document.
Q. In the resource drop zone, will dates be present when we upload? It would be great to track when certain files were uploaded and what was approved on what date.
A. The timeline indicator will display all documents uploaded and on what date. The timeline also indicates when PAAB response letters are emailed and a copy of the letter is available for viewing.
Q. Is there a maximum file size to upload?
A. The new system will accommodate very large PDF files of over 100 MB. We encourage Clients to compress all large files to facilitate the upload process. Individual internet bandwidth may be a factor in the time to upload a document.
Q. What are all the accepted file types for videos/multimedia?
A. The accepted file types for Multimedia are: .mov, .mp4, .avi, .mpg, .flv, .wmv
Q. Will the PAAB letters continue to be sent via email as before? Or will we have to check the PAAB dashboard to check for letters from now on?
A. The PAAB will continue with the current practice of emailing all response letters to Clients. The letters will also be available for viewing on the timeline of the specific file.
Q. Will uploaded references be available indefinitely...can they be re-attached from your cloud for PAAB renewals of the same file, i.e., a year later?
A. Yes, all references uploaded and stored in the document library are available to respective Clients for a period of 7 years.
Q. Will soft copies of past approval letters be available on the efile site?
A. All content of efiles, including response letters will be migrated to the new system in the same format a new file is submitted to the new system. That is, past approval letters will be available on
the new system.
Q. How/why were green, yellow and red selected as indictors of progress status?
A. Green to start, yellow is in progress and red indicates that the due date is approaching.
Q. Do notifications come in to both admin and the backup person? or just the backup?
A. Notifications will be emailed to the contact person and assigned backup persons.
Q. Do you still have access to all other documents and paab letters on the timeline view after paap approval? Not just the approval letter?
A. Yes, you may view all documents and letters of a particular efile via the timeline.
Q. Are we notified if submissions or replies will come back late?
A. No, please watch your file status and due date fields. If a response is not received by the end of day on the due date, please contact the PAAB office.
Q. Is there an option for expedited review?
A. Requests for an expedited review may still be noted in the Efile notes field or in a cover letter.
Q. What is a draft submission?
A. A submission completed in whole or in part that has not yet been submitted to PAAB.
Q. Is there a help feature if you forget something?
A. A training video will be located on the Homepage of the new system as well as on PAAB.ca.
Q. Is there a standardized structure for upload of submission. Ie Cover Letter, Copy, references and is there capability to re-order without deleting files.
A. No, there is not a standardized format to upload documents to the system.
Q. What if you made a mistake and you need to retract in 5-10 minutes of submission?
A Once you have submitted a file to PAAB, processing may commence at any time. Please ensure that all documents uploaded to a file are complete and accurate before you select to submit the file to PAAB. A reminder pop-up will be seen once you select to submit a file to PAAB.
Q. Can you remove documents from “My Files”?
A. No, the file library for each company is held on our server to receive new documents.
Q. What happens when there are many copies of the same reference in "myfiles" considering all could have individual annotations for each eFile.
A. We suggest that you use the ‘Friendly Name” function to identify like documents that are marked specifically for a select efile.
Q. Is the library agency specific OR product specific OR user specific?
A. The library is Agency specific.
Q. Can I view my uploaded documents before I submit?
A. Not at this time. You can see the name of a document that has been uploaded to a draft submission, but you cannot open the document in its’ uploaded state.
Q. Are extensions still by email only or can they also be submitted on here?
A. At this time, Extension and FYI requests will continue with the current process. However, we are exploring the opportunity to process these requests through the new system.
Q. If you would like to request a call with the reviewer do you still email info@PAAB?
A. Yes, you may email your request to email@example.com or firstname.lastname@example.org or call our office directly.
Q. Will each user see the same submission list?
A. As with our current system, each User will view and work files which they are directly connected to as a main contact or as a backup person. An administrator can view all company submissions but can work only those files of which they are directly connected.
Q. Will there be an alert/alarm for renewal dates?
A. Not a this time of launching the system, but in future development.
Q. If there is an incomplete docket, will we still be emailed to draw it to our attention?
A. Yes, this practice will remain the same in the new system.
Q. If you are a sponsor/manufacturer using an agency to submit on your behalf and you change agencies, can the previous submissions be moved to the new agency?
A. No, for security reasons, access to a particular file cannot be transferred to a subsequent agency. A new file submitted is required by the new agency.
Q. Is it possible to set permissions for the system to view only, ie, can see submissions, timelines, invoices, etc but cannot modify or create submissions?
A. Client Administrators have the ability to view the contents of all files submitted by a Client, however, Administrators can work files that indicate that they are the Contact or are listed as a backup person on a particular file.
Q. When can we go in and change our admin?
A. A Client Administrator can modify current User’s status or add new Users at any point in time. A User can update their profile at any point in time. Backups may be added to a file once it is
Complete and submitted to PAAB.