Client Services

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PAAB Services

Pre-Clearance Review

The highly trained PAAB staff runs the preclearance program to ensure that proposed advertising meets Code standards for promotion of pharmaceutical products. The code was created (and is maintained on an ongoing basis) by a multi-stakeholder Board of Directors comprised of equal representation between industry and non-industry members. A key principle of the Code is that advertising must be accurate, balanced, evidence-based, and reflective of current/best practice. This preclearance system therefore fosters trustworthy healthcare communications within the regulatory framework.

Materials are reviewed until they reach approval. Materials which have been granted PAAB approval are authorized to bear the PAAB logo as a symbol of that approval. The PAAB is recognized for making decisions about claims in advertising based on the review of scientific evidence. The PAAB will not grant approval or the use of its logo for advertising materials that do not meet the standards of evidence of this code, irrespective of the category of healthcare product.

PAAB reviews advertising directed to healthcare professionals and patient information provided through healthcare professionals for Schedule F products (prescription products), Schedule D products (biologicals), and non-prescription products (over the counter medications, natural health products, and homeopathic products). PAAB also provides an advisory DTC service (see DTC services).

Please see the PAAB Fee Schedule under Resources for the current preclearance fees.

DTC Services

The PAAB provides a user fee advisory service on direct to consumer (DTC) promotional activities regarding the treatment of disease with Federal Drug Schedule F, and Schedule D biological drugs. The allowable activities are stated in the Health Canada policy "The Distinction Between Advertising and Other Activities" and that document is used as the basis for the review. The PAAB advisory review service is recognized and endorsed by Health Canada. PAAB maintains a liaison with Health Canada regarding the regulation of promotional activities for healthcare products.

The Health Canada policy "The Distinction Between Advertising and Other Activities" can be found at the following link:
http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/advert-publicit/actv_promo_vs_info-eng.pdf

Please see the PAAB Fee Schedule under "Resources" for the current advisory fees.

Current DTC activities reviewed by the PAAB are:

  • Help-seeking Messages
  • Consumer Brochures
  • Consumer Websites
  • Consumer Ad Campaigns
  • Institutional Messages
  • Brand Reminder ads
  • Press Releases
  • Clinical Trial Recruitment
  • Physicians Websites
  • Disease Information

Materials are reviewed until they reach a "no objection" status. Materials which have been granted "no objection" status are authorized to bear the PAAB logo as a symbol of that approval.

Opinions

The PAAB offers a written opinion service to help clients understand the PAAB code better, make good decisions and to provide direction during project development. Opinions can be requested:

  • To clarify what is advertising subject to the regulations
  • To clarify exemption from review
  • To receive guidance on the acceptability of concepts
  • To clarify linkage of material
  • To receive guidance on the acceptability of references for product claims.
  • To clarify contextual issues

Only one opinion letter is provided per opinion submission. If clarification is needed about anything written in that letter, the PAAB review staff will respond to requests by telephone. Generally 5-10 minutes should be all that is needed. Final approval would be provided only after completion of pre-clearance review.

Please see the PAAB Fee Schedule under Resources for the current opinion fees.

Meetings

Clients may find it helpful to arrange meetings with the PAAB to go over advertising concepts, advertising review files, distinguishing advertising versus information, pre-launch information/materials, etc.

PAAB also holds training meetings. See "Workshops" for more information.

Meetings can be requested by contacting Chief Review Officer Patrick Massad at patrickm@paab.ca.

Please see the PAAB Fee Schedule under Resources for the current meeting fees.

Monitoring

The PAAB monitors all advertising/promotion systems to determine whether they have received PAAB clearance. Any company whose APS has been published without PAAB clearance is contacted by the PAAB and requested to suspend further distribution of the APS until it has received PAAB clearance. The PAAB will send a copy of his letter to the publishers or their agents. Penalties for violations will be dealt with under Sections 9.9 of the Code. The PAAB also monitors trends in health product advertising and promotion and adjusts its code and practices as required to fulfill its mandate.

Complaints

Complaints against Advertising Promotion Systems (APS) may be lodged by: health professionals, health care organizations, pharmaceutical companies, federal regulatory bodies including Health Canada, drug payer organizations including provincial ministries of health. Refer to section 9 of the PAAB code for administrative process and fees.

Workshops

PAAB wants to help you learn the rules. We offer national workshops in Toronto and Montreal twice yearly. These are open for anyone. Click on Events for national workshop descriptions, timing, and registration. PAAB can also perform in-house workshops at your company upon request. Contact Chief Review Officer Patrick Massad at patrickm@paab.ca or Jon Gwillims to set one up. Please see the PAAB Fee Schedule under Resources for the in-house training fee.

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