Emailing Guidelines to HCPs
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Is the following Rep email considered as PAAB exempt? The email contains no brand logo, has an open field for the Rep salutation and 1 line of copy: “Here is the link to the complete Guidelines that we discussed today”.Here are 4 different scenarios:
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Guidelines are Canadian and fully aligned with TMA of product. The link in the email points to the first page of the Guidelines.
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Guidelines are International, endorsed by a Canadian authoritative source and fully aligned with TMA of product. The link points to the first page of the Guidelines.
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What changes if the link points to a specific page within the Guidelines vs. the first page?
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What changes if these same Guidelines contain data or information not reflected in the TMA of another product in a different therapeutic category that is promoted by the same Rep (target audience would also be different)?
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Is the following Rep email considered as PAAB exempt? The email contains no brand logo, has an open field for the Rep salutation and 1 line of copy: “Here is the link to the complete Guidelines that we discussed today”.
Here are 4 different scenarios:
-
Guidelines are Canadian and fully aligned with TMA of product. The link in the email points to the first page of the Guidelines.
-
Guidelines are International, endorsed by a Canadian authoritative source and fully aligned with TMA of product. The link points to the first page of the Guidelines.
-
What changes if the link points to a specific page within the Guidelines vs. the first page?
-
What changes if these same Guidelines contain data or information not reflected in the TMA of another product in a different therapeutic category that is promoted by the same Rep (target audience would also be different)?
Good Morning @georgian21
Rep emails are considered PAAB exempt when they are true one-to-one communications. If this is not truly a one-to-one communication (pre-prepared, sent to many etc.) it would not be considered exempt. (See Dissemination” in the document Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context)
To address the various scenarios:- This would be acceptable
- This would likely be acceptable upon confirmation from the Canadian medical body in the respective field (What constitutes current medical opinion)
- An assessment of the link and linked content would be made during the review process
- Link to specific sections would not be acceptable. Linking to the homepage of authoritative consensus guidelines may be considered
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