Ottawa posts regulations for mandatory drug-shortage reporting by manufacturers
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July 03, 2016 - 1:00 PM
TORONTO - Health Canada has published final regulations requiring mandatory reporting by the pharmaceutical industry of any drug shortages and discontinued sales of medications.
The regulations, published online Wednesday in the Canada Gazette, Part II, will be supported by a new third-party reporting website to be available by spring 2017.
“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," Health Minister Jane Philpott said in a statement.
"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."
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 six 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A draft guidance document to help manufacturers comply with the new requirements to report drug shortages and discontinuances will be available shortly for consultation, the federal department said in a release.
The third-party reporting website being developed will include a number of enhancements, such as drug-specific email 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 said it expects manufacturers to continue posting shortage and discontinuances to www.drugshortages.ca and to implement the prevention strategies laid out in the guide document to help reduce the number of supply disruptions.
News from © The Canadian Press, 2016