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190 - Hi there, If a company wants to write a private letter to MPs, Senators, government officials (elected or appointed) with regards to their product, issues a company is facing with regards to approvals/existing regulations/legislation etc, does that letter require PAAB approval? To what extent are pharmaceutical companies required to submit letters to government officials to PAAB for review/approval?

FYI post-approval change/preclearance exemption/what requires review/PAAB scope

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Jennifer Carroll

wrote on last edited by Jennifer Carroll

#1

A letter to an MP, Senator, or government official would be exempt from PAAB preclearance. The letter should be issue oritented and not promotion oriented. We've been made aware of complaints relating to formulary bodies receiving drug advertising.
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