On June 17, 2026, Health Canada published the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices). The new measures comprise amendments to the Food and Drug Regulations and the Medical Devices Regulations and are intended to strengthen Health Canada’s ability to prevent, mitigate and respond to drug and medical device shortages. Key changes include:
- Expanded scope of drugs subject to shortage regulations: the amendments incorporate by reference a List of Drugs for the Purposes of Section C.01.014.8 of the Food and Drug Regulations (Expanded Scope List) that would be subject to regulatory obligations related to shortages. The amendments allow the Minister of Health to add a drug or class of drugs to the Expanded Scope List if there are reasonable grounds to believe that a shortage or discontinuation could present a risk of injury to human health, including certain over-the-counter drugs. The Minister also has the authority to require information about shortages of a wider range of drugs in certain circumstances.
- Authority to extend drug expiration dates to address shortages: the amendments incorporate by reference into the Food and Drug Regulations a List of Drugs with Extended Expiration Dates. The Minister has the authority to add any lot or batch of a drug authorized for sale in Canada if it has reasonable grounds to believe that there is a shortage or risk of shortage that could present a risk of injury to human health and that the product will comply with its specification up to and including the extended expiration date. Such lots or batches would be permitted for sale until the extended expiration date specified on the list.
- Updates to exceptional importation and sale frameworks: the exceptional importation and sale framework permits foreign authorized drugs and medical devices to be imported and sold in Canada to address actual or anticipated shortages (List of Drugs for Exception Importation and Sale). Amendments to the Food and Drug Regulations allow the framework to be used in a broader range of circumstances while mitigating safety risks. Amendments to the Medical Devices Regulations clarify the scope of the framework and allow it to be better aligned with the drug framework.
- Updates to reporting frameworks: the amendments change the existing requirements for the reporting of drug and medical device shortages and discontinuations:
- Drugs: market authorization holders are now required to provide notice of their decision to discontinue a drug authorized for sale in Canada 12 months before discontinuation (previously six months). They are also required to notify Health Canada if they have not sold a drug in Canada for a period of 12 months.
- Medical devices: when in force, manufacturers and importers will be required to report an actual or potential shortage even if a substitute device is available. The amendments also introduce a 12-month advance notice for device discontinuations.
The amendments relating to medical device shortage and discontinuation reporting will come into force on June 17, 2027. The remaining amendments have been in force since June 17, 2026.
We previously reported on Health Canada’s proposed amendments, which included requirements for safety stocks of select drugs, shortage prevention and mitigation plans, and reporting of surges in demand. In response to industry feedback, these proposed obligations were not included in the final amendments.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.