Health Canada has issued Drug Establishment Licensing (DEL) Bulletin 195 (March 17, 2026), reminding industry stakeholders of key obligations amid ongoing Middle East conflict-related shipping disruptions.
At AmoSey Inc., we believe staying ahead of regulatory developments is critical to protecting the integrity of Canada's drug supply — and the patients who depend on it.
Here's what you need to know:
Transportation & Storage
• Evaluate any new shipping routes or methods using Quality Risk Management (QRM) principles
• Review stability data, freeze/thaw studies, and high-temperature cycling data for affected products
• Add risk mitigation strategies like temperature monitoring points throughout shipments to assess conditions in real time
• Review and Update your risk evaluations accordingly
• If you are a wholesaler, you should seek guidance and recommendations from your supplier if you don't have this information
Drug Shortage Reporting Requirements
Market Authorization Holders (MAHs) are reminded of their legal obligations under the Food and Drug Regulations:
• Report anticipated shortages or discontinuations at least 6 months in advance — or within 5 days if the event is less than 6 months away
• Report actual or unanticipated shortages or discontinuations within 5 days of becoming aware
• Update existing shortage reports or discontinuation reports within 2 days of any new information
If you hold significant market share or are a sole supplier of an affected drug, notify Health Canada's Drug Shortages Unit directly.
Proactive compliance isn't just a regulatory requirement — it's how we protect Canadians.
Read the full bulletin: Addressing potential drug supply and shipping issues during the conflict in the Middle East Drug Establishment Licensing Bulletin 195, March 17, 2026
