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Controlled Substances – Clarification on Rules for Promotional and Informational Materials
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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Hi,
Are controlled drugs listed under Schedule I of the Controlled Drugs and Substances Act subject to the same marketing and advertising regulations as opioids?
Is it permissible to create and provide promotional materials for controlled drugs to healthcare professionals or medical staff?
If not, can product fact sheets still be distributed? -
This post was answered through our office earlier but we will post the answers here as well.
- No, only opioids are subject to the Health Canada terms and conditions for advertising.
- It is permissible to create promotional materials to HCPs for a controlled drug. However, note that direct to consumer advertising is not permitted.
