Health Canada has published amendments that give the regulator more tools to anticipate and manage shortages of drugs and medical devices. The changes, registered as SOR/2026-96, were published on June 17, 2026 and amend both the Food and Drug Regulations and the Medical Devices Regulations.
What changes for drugs
- Wider scope. Health Canada can extend shortage-related requirements to more categories of drugs by adding them to a list, without a new round of regulations. Law firm commentary notes this does not immediately create new reporting duties.
- Expiry extensions. The regulator can extend the expiry date of specific lots when that helps prevent or ease a shortage and the evidence shows the product still meets safety, efficacy and quality standards.
- Exceptional importation. The framework for bringing in foreign-authorized products during a shortage has been strengthened.
- Twelve-month non-sale notice. Manufacturers must tell Health Canada when a drug has not been sold in Canada for twelve months, even if it has not been formally discontinued.
What changes for medical devices
A new shortage and discontinuation reporting framework for medical devices is coming, but it does not take effect until June 17, 2027. Until then, current requirements continue to apply. Device manufacturers, importers and distributors are expected to use the transition period to update their reporting procedures.
Why it matters for buyers and suppliers
For pharmacies, hospitals and procurement teams, the practical effect should be earlier visibility of supply problems and more flexible options when a product runs short. For suppliers serving Canada, it is a good moment to review how shortage information is tracked and shared with customers. Agentic Rx monitors these developments as we expand supply of OTC products, vitamins and medical supplies into Canada.
This article summarises public reporting for general information. It is not medical, legal or regulatory advice. Please check the original sources and current rules before acting.
