Information about controlled substance advertising regulations
Hi PAAB, what are some good resources to learn more about discussing controlled substances with HCPs including promo, rep activities, sampling, etc?
Jennifer Carroll last edited by
Hello @gbrl88 ,
We’ll begin by reiterating that promotion of these products to the public is strictly prohibited. Now onto your question. With regards to HCP advertising, the provisions of the PAAB Code apply to all healthcare products including narcotics and controlled drugs.
The Food and Drugs Act, the Food and Drug Regulations, the Controlled Drugs and Substances Act, and the Narcotic Control Regulations outline Federal requirements pertaining to promotional materials and promotional activities (including sampling). Note that provinces may also impose additional local restrictions pertaining to sampling activities. The Innovative Medicines Canada Code of Ethical Practices also contains standards pertaining to the activity of sampling.
You may have heard that Health Canada has recently amended healthcare product sampling laws. These amendments came into effect on July 1, 2020. But they do NOT impact sampling pertaining to controlled drugs.
Importantly, for opioids (specifically those on Part B of the Opioids list), Health Canada has established Terms and Conditions that must be adhered. This was followed by additional restrictions on marketing of opioids.
Does anyone in this community use additional resources pertaining to the question? If so, sharing is caring! Post them in this thread.