Testing Exemption for Low‑Risk Non‑Prescription Drugs

Summary#

These are the final Regulations Amending the Food and Drug Regulations (Finished Product Testing), registered as SOR/2020-73 on April 7, 2020 and published in the Canada Gazette on April 29, 2020. They let some low‑risk, non‑prescription drug products made and tested in trusted foreign jurisdictions skip Canada’s repeat finished‑product testing and be shipped straight to Canadian retailers, distributors or wholesalers. Importers must keep a batch certificate and remain responsible for product safety.

What it does#

• Adds a new exemption to the Food and Drug Regulations that removes the requirement for Canadian importers or distributors to retest certain finished non‑prescription drugs before sale, if those products were fabricated, packaged/labelled and tested in a recognized foreign jurisdiction.
• Allows qualifying finished products to be shipped directly to retailers, distributors or wholesalers in Canada without first being retested in Canada.
• Sets conditions for the exemption, including that:
  • the product is on the Health Canada list called List of Non‑prescription Drugs Not Subject to Certain Testing Requirements;
  • the product was fabricated, packaged/labelled and tested in Canada or in a country on Health Canada’s recognized list (members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S));
  • the importer or distributor keeps a copy of the batch certificate for each lot or batch and is satisfied the product meets approved specifications;
  • importers and distributors put controls in place (for example, quality agreements) when they rely on third parties to handle the product.
• Incorporates the two lists (the product list and the list of recognized countries/authorities) by reference so Health Canada can update them on its website without changing the Regulations.
• Comes into force on the day that section 7 of the Canada–United States–Mexico Agreement Implementation Act comes into force, or on the day the regulations are registered if that is later.

Who's affected#

• Importers, distributors, retailers and wholesalers of lower‑risk non‑prescription drug products (examples below).
• Manufacturers who have finished products fabricated, packaged/labelled or tested in PIC/S countries.
• Laboratories and testing businesses that perform finished‑product testing in Canada (they may see less demand for some products).
• Health Canada, which will maintain oversight and manage the lists and compliance checks.

Products specifically mentioned as qualifying under these rules include toothpastes, mouthwashes, sunscreens, anti‑dandruff shampoos, diaper‑rash creams, many medicated skin care products (with some exclusions), acne products, throat lozenges and athlete’s foot creams. The exact products and exporting countries that qualify are set out on the Health Canada lists.

Why it matters#

• Faster access: qualifying products can reach Canadian store shelves sooner because they do not need duplicate testing in Canada. Industry observed shipment times could improve by about two to four weeks during earlier pilot work.
• Lower costs and smoother supply chains for businesses that choose to use the exemption. That may also translate to better availability or lower prices for consumers, depending on business choices.
• Trade and regulatory alignment: the change implements obligations under the Canada‑U.S.‑Mexico Agreement (CUSMA) and relies on international cooperation through PIC/S to trust foreign GMP inspections.
• Safety remains a requirement: importers and distributors keep responsibility for ensuring products meet specifications and must retain batch certificates; Health Canada will continue inspections and targeted compliance checks.
• Flexible lists: Health Canada can update the lists of products and countries as needed. This allows the rules to adapt to new evidence or changes in foreign regulatory status.