• 56c764a1-aaf0-447f-9c94-ddeb0e19419a-image.png 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:

    1. Guidelines are Canadian and fully aligned with TMA of product. The link in the email points to the first page of the Guidelines.

    2. 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.

    3. What changes if the link points to a specific page within the Guidelines vs. the first page?

    4. 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:

    1. This would be acceptable
    2. This would likely be acceptable upon confirmation from the Canadian medical body in the respective field (What constitutes current medical opinion)
    3. An assessment of the link and linked content would be made during the review process
    4. Link to specific sections would not be acceptable. Linking to the homepage of authoritative consensus guidelines may be considered