Guidance Document on the Distribution of Drugs as Samples - Summary

Overview

The purpose of this document is to assist stakeholders with the interpretation of legislation and regulatory requirements about distributing samples of prescription drugs, non-prescription drugs and natural health products.

Who this guide is for

• Industry stakeholders distributing drugs as samples
• Practitioners and pharmacists receiving drugs distributed as samples
• Canadian consumers receiving drugs distributed as samples

Background

Amendments to regulations 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.

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.

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”.

Please contact the Stakeholder Engagement Division (SED) of the Natural and Non-prescription Health Products Directorate, to request a copy of the guidance document at  nnhpd.consultation-dpsnso@hc-sc.gc.ca

To view the lists of drugs and natural health products that can be distributed as samples directly to consumers, please visit the following links:

• List A: List of Certain Natural Health Products for Distribution as Samples, and
• List D: List of Certain Non-prescription Drugs for Distribution as Samples.

For assistance

Contact us by email: nnhpd.consultation-dpsnso@hc-sc.gc.ca