Health Canada – OTC Monograph Reform under the CARES Act – What to Know?

Health Canada – OTC Monograph Reform under the CARES Act – What to Know?

October 8, 2020 By

In Canada, prior to July 1, 2020, drugs, which are inclusive of prescription drugs, non-prescription drugs (also called over-the-counter [OTC] pharmaceuticals), and natural health products (NHPs), were not permitted to distributed as samples to the general public. Samples were only allowed to be distributed by physicians, dentists, veterinary surgeons, or pharmacists under prescribed conditions to their patients.

However, with the advent of Canada entering a trade agreement with the United States and Mexico known as the Canada-United States-Mexico Agreement (CUSMA), Canada made a commitment to permit certain subsets of drug products (mainly those with localized and non-systemic effect or for topical use) to be allowed to be distributed as samples more broadly to the general public (still under certain requirements) and allow a larger subset of health care practitioners to distribute them. Thus, on July 1, 2020, amendments were made to the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations.

These amendments to align with CUSMA permits not only health care practitioners to distribute samples to patients (within their scope of practice), but also allows organizations and individuals to distribute directly to adult Canadian consumers (18 years or older). The drug sample distributor must also be an adult (≥18 years old) and demonstrate knowledge of a drug’s risks, benefits and proper directions of use.

Currently, the scope of products that are permitted to be distributed directly to consumers are explicitly outlined in two authoritative lists:

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

In general, the categories of products permitted to be distributed directly to consumers are mainly those applied to the skin (sunscreens, diaper rash, antiperspirants), hair (anti-dandruff products), or mouth (toothpaste, mouthwashes, lozenges). Products that are not on these two lists can be still be provided as samples, but only to the health care practitioner or pharmacist directly and requiring their signed order.

Please note that the distribution of a drug as a sample is considered a “sale” under the Food and Drugs Act (FDA) and must comply with all conditions required to “sell” a drug such as having a market authorization (aka being registered with Health Canada), complying with advertising, packaging and labelling requirements, complying with good manufacturing practices, having adverse event reporting and obtaining a site or establishment license, as appropriate. The drug samples distributed should also not be past their expiry date nor be within 30 days of their expiry date.

Health Canada had issued a Notice of Proposal in August 2020 and started a 60-day consultation period, ending on October 10, to expand the two lists of certain products permitted for distribution as samples and had also requested industry feedback. Following the industry feedback period, work will begin on modifying the list of products permitted to be distributed as samples (along with any official Notices of Modification). Health Canada will be providing more details on the timing of the regulatory changes as the work advances.

For assistance in assessing your products as an NHP or OTC pharmaceutical, registering them to sell in the Canadian market, and their eligibility to distribute as samples (including ensuring they meet all of the conditions to be permitted for “sale”) in the Canadian market, be sure to contact dicentra for any information you need and to find out more on how we can help you.

Quick Links:

  1. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/distribution-drugs-samples-summary.html
  2. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/lists-incorporated-by-reference/list-a-natural-health-products-distribution-samples.html
  3. https://www.canada.ca/en/health-canada/services/self-care-regulation-non-prescription-drugs/list-d-non-prescription-drugs-distribution-samples.html