Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Developing APS for an Rx product with no PMs
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Hi! How do we go about developing an APS for a prescription schedule product that does not have a Product Monograph? The main content cap is the development of the fair balance (including the indication, and a link to a PM). Thanks in advance!
Hey @dmauri
Section 7.3 of the PAAB Code states “Advertising with Product Claim Link to Terms of Market Authorization:
One of the following must appear prominently within the main advertising message of the APS:
- Electronic link(s) to the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant)
- URL(s) for a webpage containing the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) accompanied by a statement that these documents are also available upon request through a stated phone number.
The definition of “Terms of Market Authorization” can be found in the Code and reads as follows:
Information in the Product Monograph, labeling and product license and the document that assigns a Drug Identification Number (DIN), Natural Health Product number (NPN) or homeopathic product number (DIN-HM), including related product labeling material and prescribing information, authorized by Health Canada.
When a Product Monograph is the basis of authorization, it should be linked. If authorization was granted based on a Product License, providing a link to that document would meet the requirements of section 7.3. The TMA document would be the basis for review of the ad.
