Due to shipping disruptions from conflicts in the Middle East, Health Canada reminds importers and distributors to maintain GMP compliance by using Quality Risk Management (QRM) to evaluate new routes. This includes assessing environmental risks, reviewing product stability data, and enhancing temperature monitoring.
Additionally, Market Authorization Holders (MAHs) must strictly adhere to mandatory shortage reporting timelines:
- Anticipated shortages: At least six months’ notice.
- Immediate shortages: Within five days of discovery.
- Status updates: Within two days of any change.
Sole suppliers or major market shareholders must also email Health Canada’s Drug Shortages Unit directly to coordinate early intervention.
