Should Drug and Medical Device Companies Be Required to Report Shortages Earlier?
Official title: Share your views: Consultation on proposed amendments to regulations to address health product shortages in Canada
Why This Matters
Ever gone to the pharmacy and been told your medication is out of stock? It happens more than you'd think. These rules aimed to catch shortages before they hit pharmacy shelves. For anyone who depends on regular medications—or has needed a medical device—this could mean fewer scrambles to find alternatives.
What Could Change
Drug and medical device companies may soon face new reporting requirements. They'd have to notify Health Canada earlier when shortages loom and keep safety stocks of critical medications. Health Canada would gain authority to extend expiration dates during shortages and allow exceptional imports. The final regulations will be published in the Canada Gazette, Part II.
Key Issues
- Should companies be required to report potential shortages earlier and maintain safety stocks?
- Which drugs should be classified as critical and vulnerable to shortages?
- Should Health Canada be able to extend drug expiration dates during shortages?
- How should exceptional importation of drugs and medical devices be handled during shortages?
How to Participate
- This consultation is now closed. It ran from December 28, 2024 to March 8, 2025. Review the proposed regulations in the Canada Gazette to understand what was proposed.
What Happened
The consultation has concluded. Health Canada will review the feedback received and make changes as necessary. The final regulations will be published in Part II of the Canada Gazette.