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.
Does Part 3's 'indication' require safety information?
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Hi there!
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!
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Hi there!
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!
Hello @kshulist
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.
