629 - Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks
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The following guidance is provided under the assumption that this is the entire content of the piece. The Food and Drug Regulations prohibit discussion of the approval process within advertising. If we were to reframe the question to a message of “Now available in Canada”, while the message itself would be considered exempt from PAAB review, it is still advertising and subject to the standards of the PAAB code. Messages of “new” are restricted to one year post marketing. Stating that the product is “now available” without limiting the claim to the new 2nd indication, would be misleading. The 2nd indication would need to be included to accurately limit the ”new” claim and this would render the piece non-exempt. See code section 1.5D for a list of exempt messages.
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@jennifer-carroll said in 629 - Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks:
he Food and Drug Regulations prohibit discussion of the approval process within advertising
@Jennifer-Carroll Does the note regarding the Food and Drug regulations not allowing us to use the term "approved" in a message still apply in 2024? Wanted to ask given that this response is from 2019. Thanks.
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Yes. The Food and Drug Regulations have not changed with respect to this.
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Jennifer, I can't for the life of me find the support to your comment in the Food and Drug Act. I was hoping to annotate the document to send to the client. Can you direct my eyes i.e., section number and page. Thanks.
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Hey @gmc
Food and Drug Regulations – C.01.007
