New regulations for industry reporting now finalized
OTTAWA, June 29, 2016 /CNW/ - Today, Health Canada publishedfinal regulations in the Canada Gazette, Part II requiring mandatory reporting by industry of drug shortages and discontinuances of sales. Health Canada is on track to implement these regulations, which will be supported by a new third
When in force, the regulations will require drug manufacturers to:
Manufacturers will also be required to provide additional information to Health Canada when a drug is discontinued, such as the drug identification number (DIN) and the latest expiration date; and, notify Health Canada of the interruption of the sale of certain drugs when they have not been sold in Canada for 12 consecutive months.
A draft guidance document to help drug manufacturers comply with the new requirements to report drug shortages and discontinuances will be available shortly for consultation.
When a critical national shortage occurs, Health Canada works with players from across the drug supply chain, including our provincial and territorial partners, to confirm the details and status of the shortage, coordinate information sharing, and identify collaborative mitigation strategies.
"We recognize that drug supply disruptions are still occurring far too often and that these situations can cause considerable stress on Canadians and their families. That is why we are committed to increasing our efforts to improve reporting of shortages and discontinuances, and working with manufacturers to prevent drug shortages from happening in the first place, whenever possible."The Honourable Jane PhilpottMinister of Health
Drug Shortages in Canada
Harper Government Moves to Implement Mandatory Drug Shortage Reporting
Government of Canada Moves Forward with Mandatory Reporting of Drug Shortages and Discontinuances
Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media.
SOURCE Health Canada
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