The types of messages listed in section D are exhaustive. However, it is not exhaustive of how the principles might be demonstrated in a specific APS. We offer our opinion services if a company is unsure if an APS meets exemption criteria.
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Given the scenario above, the reprint carrier would be subject to PAAB review as distribution of a reprint carrier qualifies as an advertising/promotions system (APS). The tool is likely subject to lowest level fair balance requirements.
Hey @stanley, sorry for the late response, this one must have slipped through the cracks.
S.1.5 is not considered to be an exhaustive list. The copy “X is back in stock” would be viewed as a commercial availability message. If it was not linked to any other messaging, it could be considered exempt.
You are correct, the addition of the indication statement would create a link to the therapeutic use and prompt at least lowest level fair balance and PAAB review.
It is likely that this would be considered advertising and not subject to the exemption criteria outlined in Section 1.5D of the code which state “Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages”. The promotions of advertising tools would be considered a link to promotional messages. When we link advertising to non-advertising, everything becomes advertising.
The Distinction Between Advertising and Other Activities, the Health Canada document which outlines what constitutes advertising, asks a series of questions to determine the nature of the activity. The author and distributor being a medical director in and of itself, does not, in and of itself, necessarily render a piece exempt from Federal advertising regulations, the PAAB Code, or PAAB preclearance. Please see PAAB Q&A 403. While this question asks about “slides”, the same would apply to letters, emails, etc.
PAAB Q&A 750 also walks through a similar set of questions to ask about the activity.
A letter stating only that the sponsor’s product is available would be exempt from preclearance regardless of the source within the company. But it should be noted that certain industry association Codes do not permit such promotional materials to be signed by Medical/Scientific personnel.
Similarly, a letter only indicating that the sponsor’s product is not available would also be exempt. However, in my experience, when such a letter is signed-off by medical/scientific personnel, it’s because the letter goes beyond that simple message (e.g., why the shortage exists, when the shortage is expected to be resolved, what is being done to mitigate the shortage, what prescribers can consider in the meantime, or so on). Anything on this matter beyond the fact that the product is available or unavailable would require preclearance.
If you are unsure if the activity would be considered advertising, and if that advertising requires review, please submit a request for a written opinion (see fee schedule on the PAAB website).
A link to the formulary site for any province would render the piece subject to review. While a message of “now on formulary” may be considered exempt and the formulary alone is not within the scope of the PAAB code, the linking of the two pieces renders the content subject to the advertising provisions as it creates a link between the brand and a therapeutic message. As per PAAB Q&A 565, the link to RAMQ coverage would be considered a therapeutic link. Hope that helps.
As per “Chapter 4. Post Approval” in the document “Guidance on Submission Process”, a request for extension can be submitted for assessment. An annotated copy of the product monograph with all changes since the previous TMA should be uploaded. The PAAB will make an assessment to see if the changes to the product monograph impact the piece. It is possible for changes deemed to be “minimal” by the sponsor, to still have a meaningful impact on the piece. Upon PAAB assessment, if the piece is still deemed to meet the requirements of the Code, a maximum 2 month extension can be granted.
Note that it is the responsibility of the manufacturer to ensure that they are not using a piece which is inconsistent with PM updates occurring during approval and/or extension periods.