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.
