Author: Teri Dickinson, Manager, Regulatory Affairs, Dell Tech Laboratories Ltd.

Beginning July 1, 2020, industry will be able to distribute certain non-prescription drugs and NHPs as samples as a strategy to encourage their use on a trial basis. This may provide benefits to Canadians, practitioners and pharmacists by increasing their knowledge of available health product options to meet their needs.

Amendments to the Food and Drug Regulations following the ratification of the Canada-United States-Mexico Agreement, now permit the distribution of specific low risk non-prescription drugs and natural health products as samples under certain conditions.  Section 14 of the Food and Drugs Act previously prohibited the distribution of drugs as samples other than to physicians, dentists, veterinary surgeons or pharmacists, under prescribed conditions.

To assist stakeholders with interpreting the legislative and regulatory requirements associated with distributing these samples, Health Canada prepared a new guidance document entitled “Distributing samples of prescription drugs, non-prescription drugs and natural health products”.

Some of the low risk DIN and NPN products that can be distributed directly to consumers include:

• Personal Care Use Antiseptic Cleansers
• Sunscreens
• Acne Therapy Products

References:

Regulations Amending the Food and Drug Regulations (Distribution of Drugs as Samples): SOR/2020-74 - http://www.gazette.gc.ca/rp-pr/p2/2020/2020-04-29/html/sor-dors74-eng.html

Guidance Document on the Distribution of Drugs as Samples - Summary - https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/distribution-drugs-samples-summary.html