Does Part 3's 'indication' require safety information?
I know in the Branded Patient Information Guidelines (https://code.paab.ca/resources/Branded_Patient_Information_Guidance_Doc_July_16_2015.pdf) in section 1.4, it is mentioned that if "the APS includes information on how the drug works and its various features from part III", safety information is required. I was wondering if the Part III version of the indication (I think it's usually subheaded with "What is DRUG used for?" or similar) falls into this category? If a branded patient piece only includes what the drug is used for, would that be considered a "various feature" of the drug and require safety information? Thanks for your help!
Jennifer Carroll last edited by
When the piece speaks to what the drug is for (beyond what is consistent with the Part I indication), how it works, and/or its various features, the piece should contain safety information. The principle is that patient pieces should be balanced and complete. They should not be about overly selective presentations from part III of the PM.