Combining RMM and Branded Materials
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Dear PAAB,
We would like to combine a branded patient brochure and a branded patient risk management measure (approved by Health Canada and PAAB) together into a folder for dissemination to patients.
Since both pieces are non-promotional and would only be provided to patients already on the medication by their prescribing physician, can you advise if this would be compliant?In the same context, can you please confirm that the folder in question be exempt from PAAB review if it only featured the brand logo with a simple label like Patient Materials?
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Dear PAAB,
We would like to combine a branded patient brochure and a branded patient risk management measure (approved by Health Canada and PAAB) together into a folder for dissemination to patients.
Since both pieces are non-promotional and would only be provided to patients already on the medication by their prescribing physician, can you advise if this would be compliant?In the same context, can you please confirm that the folder in question be exempt from PAAB review if it only featured the brand logo with a simple label like Patient Materials?
Hi @supraja
When a Risk Management Measure/Tool (RMM/T) is intended to be distributed with any other PAAB reviewed pieces, the entire package is considered in context and should be submitted as a separate PAAB review/opinion. We are unable to comment on the compliance of the proposed APS without assessing the content of the APS and suggest submitting for review or an opinion. During the review, we would be able to provide advice on the acceptability of the APS content and its linkages. Any folder intended to be combined with an RMM/T is also subject to PAAB review. Please see our guidance document on RMM/RMTs for context of use and other information.
