On October 7, 2026, Health Canada published a new Guide on extending expiration dates of marketed drugs in response to drug shortages (GUI-0500).
Under sections C.10.014 to C.10.021 of the Food and Drug Regulations, expiration dates of specified drug lots/batches may be extended to help mitigate the impacts of drug shortages. Once Health Canada accepts a proposal, the specified drug product batch is added to the Extended Expiration Date List and the drug can continue to be sold until the extended expiration date.
To be added to the Extended Expiration Date List, a specified drug batch must meet certain criteria, including that there is a shortage or risk of same, and the shortage, if it were to occur, could present a risk of injury to human health. Submitted evidence must demonstrate the batches will comply with product specifications until at least the extended expiration date.
Health Canada will also consider whether extending the expiration date will help prevent or mitigate a shortage and whether the specified drug product batches can be used safely based on the evidence submitted. Proposals on economic grounds will not be considered. Extended expiration dates may be shortened if the circumstances of a drug shortage change and removal from the List is possible.
In addition, Health Canada has released updates to several guidance documents relating to exceptional importation and sale of foreign-authorized drugs or medical devices to help mitigate drug shortages:
- Guide on the exceptional importation and sale of drugs in response to shortages and discontinuations (GUI-0148);
- Guide to reporting and providing information on drug shortages and discontinuations (GUI-0120);
- Guide on the exceptional importation and sale of medical devices in response to shortages (GUI-0147); and
- Guide to reporting and providing information on medical device shortages and discontinuations (GUI-0137) – comes into force June 17, 2027.
Health Canada has also released an update to the Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada (GUI-0145), explaining how to assess whether a drug establishment license (DEL) holder is prohibited, as per the Food and Drug Regulations, from distributing a drug intended for the Canadian market for consumption or use outside Canada unless there are reasonable grounds to believe the distribution will not cause or exacerbate a shortage of the drug.
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.