Addressing potential drug supply and shipping issues during the conflict in the Middle East
Drug Establishment Licensing Bulletin 195, March 17, 2026
Health Canada is closely monitoring potential impacts to Canada’s drug supply due to the conflict in the Middle East and associated disruptions to international shipping.
This DEL bulletin has been issued to remind you of:
- good manufacturing practices (GMP) during transportation and storage disruptions
- regulatory requirements related to the reporting of drug shortages and discontinuations
On this page
- Transportation and storage considerations
- Requirements to report drug shortages and discontinuations
Transportation and storage considerations
The conflict in the Middle East is disrupting international shipping. This may lead to Canadian suppliers using new shipping methods or routes.
Canadian importers, distributors and wholesalers must ensure that shipping conditions will not impact the safety, efficacy or quality of the drugs that the people in Canada rely on.
To this end, you should ensure such changes are evaluated in accordance with quality risk management (QRM) principles.
You should also:
- evaluate the new shipping route or method to determine potential risks, including extreme environmental conditions and weather events
- review known information about the product, such as all stability data and freeze/thaw and high temperature cycling studies, where available
- If you are a wholesaler, you should seek guidance and recommendations from your supplier if you don't have this information
- apply mitigation strategies such as adding temperature monitoring points throughout the load to better assess transportation conditions
- review and update your risk evaluations
For more information on shipping and storage requirements, consult the following guidance document:
Requirements to report drug shortages and discontinuations
The conflict in the Middle East and associated shipping disruptions may affect Canada’s drug supply. Therefore, we would like to remind all market authorization holders (MAHs) that they must report drug shortages and discontinuations on health product shortages.
Early reporting helps stakeholders who are affected take action to help prevent or manage the adverse health effects of drug shortages and discontinuations.
The Food and Drug Regulations outline the timelines for reporting shortages and discontinuations:
- at least 6 months before the day an anticipated shortage or discontinuation is expected to start (if more than 6 months away) or
- within 5 days of becoming aware of an anticipated shortage or discontinuation (if less than 6 months away) or
- within 5 days of becoming aware of an actual drug shortage or an unanticipated discontinuation
Stakeholders must also update existing drug shortage and discontinuation reports within 2 days of becoming aware of any changes to the information in the reports.
For more information on how to comply with the regulations, consult the following guidance document:
MAHs or DEL holders should also notify Health Canada’s Drug Shortages Unit of any shortages or discontinuations if:
- you hold a significant market share or are a sole supplier of the affected drug in Canada or
- the drug is currently classified to be in a Tier 3 shortage
To notify the unit, send an email to drug.shortages-penurie.de.medicament@hc-sc.gc.ca.