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752: My question is specifically regarding a sales rep emailing a (known, consented) HCP one on one with: A) A one line message that a product has now received Health Canada approval with approved indication. No claims, data etc B) A request to HCP to discuss Patient Support Program which may include info on the PAAB approved patient enrolment form Is this communication different if a Medical Affairs staff member sends the email? thanks very much.
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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A) Yes this message requires review.
B) Yes this would also require review. It remains an unsolicited message to promote a product or offering from the company and therefore would not be perceived as different if it came from medical affairs. We would also recommend reviewing industry codes such as the Innovative Medicines Canada Code of Ethical Practices which state that medical/regulatory/scientific personnel may not sign promotional materials. See question above.
