As of July 1, 2020, the pharmaceutical industry will be able to distribute non-prescription or over-the-counter drugs ("OTCs") as well as natural health products ("NHPs") as samples to designated healthcare professionals ("HCPs"), and in certain cases, direct to consumers.

Direct to Consumers

In particular, the distribution of OTCs and NHPs as samples direct to consumers will be permitted for low risk products with well-established safety and efficacy profiles.

This includes notably: topical acne therapy products, medicated skin care products, diaper rash products, anti-dandruff products, antiseptic skin cleansers, athlete's foot treatments and sunscreens, as well as toothpastes, mouthwashes, and throat lozenges.

For a full list of which products may be distributed as samples direct to consumers, see:

In addition, samples can only be distributed to consumers who are 18 years of age or older.

Through Healthcare Professionals

OTCs and NHPs may also be provided as samples to practitioners (further discussed below) and pharmacists for further distribution, if the distribution of these products are within the HCPs' scope of practice under provincial or territorial law.

Drugs distributed as samples that are on List D or List A can simply be provided to a practitioner or pharmacist. However OTCs and NHPs which do not appear on these lists require a signed order from a practitioner or pharmacist prior to distribution (as has been the case with prescription drugs).

Adding Products to List D & List A

OTCs and NHPs can be added to these lists but the process for each differs:

List D (OTC) is incorporated by reference on an ambulatory basis. This approach allows Health Canada to add or remove products to List D based on safety considerations. Prior to making any change, Health Canada will engage in a transparent consultation process through a Notice of Proposal on the Department's website.

NHPs however can only be added to or removed from List A by regulatory amendment.

Practitioners

Another significant change is that previously only physicians, veterinary surgeons, dentists and pharmacists could receive samples but now all practitioners1, including nurse practitioners can do so. This change is to align federal law with the HCPs' provincial scope of practice under provincial and territorial law.

Other Regulatory Obligations

These products, when distributed as samples, must meet all other regulatory requirements, including packaging and labelling requirements, in the same way as all other OTCs and NHPs.

In addition, samples cannot be distributed within the 30 days prior to or during the month of a drug's expiry date, as the case may be, or any time after a drug's expiry date.

Conclusion

These amendments were necessary to fully implement Canada's treaty obligation under the new Canada-United States-Mexico Agreement (CUSMA). They come into effect on July 1, 2020. The Health Canada, Guidance Document on the Distribution of Drugs as Samples is not publically accessible online but Fasken would be pleased to provide you with a copy on request. And of course, we remain available to assist in crafting any samples policy based on the new framework.

Footnote

1 As defined in the Food and Drug Regulations and the Natural Health Products Regulations (i.e. a person who is entitled under the laws of a province to treat patients with a prescription drug, and is practising their profession in that province).

Originally published May 26, 2020.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.