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697 - I have read the HC Policy 'Distinction between advertising...' for Press Release (PR). However I see many PR online that go beyond simply stating name and therapeutic area. Many PR mention efficacy and safety data. Am I misinterpreting the HC policy or can we in fact speak to the degree of efficacy and safety in a PR?
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The Health Canada policy document “Distinction between advertising and other activities” provides criteria which may help determine if a particular message, such as a press release, is considered to be non-promotional and thus exempt from PAAB review. One of the conditions for press releases is that no statement is made regarding the expected safety or efficacy. Informative presentations of non-comparative findings from a recently completed clinical trial would be consistent with the distinction document. If the press release does not abide by all the criteria listed in the document, then it may be deemed promotional and subject to direct-to-consumer advertising regulations.