Email Attachments
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If we create a general email for a brand, can the attachments (within the same email) include PAAB-approved branded APS, clinical publications (i.e., pivotal studies cited in the Product Monograph) and the Product Monograph?
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Hello @gmc. Apologies for missing this question.
The PAAB resource Clarification regarding digitization of APS provides direction on how to generate general email templates. These emails are subject to the PAAB Code and should go through review. Theoretically, it would be acceptable to include PAAB approved branded pieces and pivotal trial reprints and the PM. There are conditions which may occur that render the email non-compliant which would be addressed during the review process. As an example, if one of the document titles included the therapeutic area and the PM title was included with the brand name, the email would require balance.
The forum thread for the above mentioned link has additional user questions which you may find useful as well. As well, the Document names and descriptions for external use resource contains some additional examples.
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Jennifer, you mention "Fair Balance". If the brand name and therapeutic class is mentioned, but no claims, would the requirement only be for low Fair Balance?
Tina
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Hi @gmc
If limited to brand and therapeutic class, yes, lowest level would be sufficient.
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Ok, I've scoured all communications, PAAB responses and guidance documents. From what I can tell, I can mention brand and TA/disease state in the body copy of the RTE. It's the mixing of brand and TA/disease state in the naming convention that's the issue. Right? For example, could I mention the brand name and multiple sclerosis in the body copy and then attach PDFs with naming conventions that mention brand name but not TA/disease state?
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Sorry for the delay in response.
Yes, you can have brand name and TA/disease state in the body copy providing indication and appropriate fair balance is included in the email body. The attached PDFs within this email can have naming conventions with brand name only or brand name and TA that is consistent with the Product monograph, as the indication and fair balance are already in the APS.