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Bulletin

Forthcoming Regulations Requiring Drug Manufacturers to Report Shortages

Fasken
Reading Time 2 minute read
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Life Sciences Bulletin

On February 10, 2015, Rona Ambrose, the Federal Minister of Health announced that the Canadian Government is moving towards a mandatory reporting system which will require all manufacturers to publicly report drug shortages.

The Government is crafting regulations with the hope that by providing advanced warning of upcoming shortages, Canadians can proactively work with their healthcare professionals to find alternative options in advance of an anticipated shortage.

The proposed regulations will call for manufacturers to provide timely, comprehensive and reliable information on both actual and anticipated drug shortages. Drug manufacturers will have to post this information on a new, independent third-party website. While this new website and the regulations are being developed, manufacturers are still expected to voluntarily publish information on all shortages on the industry-run website.

In addition, a Public Notification Register has been launched on Health Canada's website that will list all drug manufacturers that fail to voluntarily post their shortages:

"… this public register will name and shame those pharma companies who fail to publicly post information on drug shortages, making industry commitments, but more importantly industry actions clear for all to see". - Rona Ambrose

Once the reporting of drug shortages becomes mandatory, companies will also face fines and penalties for failing to comply.

U.S. drug manufacturers are already required to notify the Food and Drug Administration about shortages, including the reasons and expected duration. Although, there are currently no civil or monetary penalties for industry noncompliance.

The regulations will be announced in the coming months. They will  not apply to shortages of veterinary drugs, natural health products, personal-care products, cosmetic-like drugs, toiletries or disinfectants.

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