Mandatory Reporting of Drugs Shortages and Discontinuances on Track for Spring 2017 Implementation
New regulations for industry reporting now finalized
June 29, 2016 - Ottawa, ON - Health Canada
Today, Health Canada published final 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 party reporting website, by spring 2017.
When in force, the regulations will require drug manufacturers to:
- Report on a public website an anticipated drug shortage, or discontinuation of sales no less than 6 months in advance;
- Post to a public website any shortage not previously reported, within five days of learning about it.
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A draft guidance document to help drug manufacturers comply with the new requirements to report drug shortages and discontinuances will be available shortly for consultation.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.
- A new third party reporting website is being developed that will include a number of enhancements, such as drug specific e-mail alerts, improved searchability, and a mobile application. Once launched, the third party reporting website will replace the industry-run website www.drugshortages.ca.
- Until the mandatory reporting website is up and running, Health Canada expects manufacturers to continue posting shortage and discontinuances to www.drugshortages.ca and to implement the prevention strategies laid out in the guide to help reduce the number of shortages that occur.
- The Multi-Stakeholder Steering Committee on Drug Shortages, which is co-chaired by Health Canada, has published a new toolkit entitled Preventing Drug Shortages: Identifying Risks and Strategies to Address Manufacturing-Related Drug Shortages in Canada. Developed in collaboration with drug manufacturers, it seeks to identify, analyze, and propose strategies to reduce and prevent the manufacturing-related causes of drug shortages in Canada.
“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 Philpott
Minister of Health
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Office of Jane Philpott
Minister of Health
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