Consultation: Draft –Guide to reporting drug shortages and discontinuations
The Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) were published in the Canada Gazette, Part II on June 29, 2016, and will come into force in spring 2017. Upon coming into force, the Regulations will introduce new requirements as part of the Food and Drugs Regulations for drug manufacturers to:
- publicly report drug shortages and discontinuations on a new third party website; and
- report interruptions of sales to Health Canada when a drug has not been sold for 12 consecutive months.
Information on the Document
The document for consultation, Draft – Guide to reporting drug shortages and discontinuations provides information to help affected drug manufacturers comply with the new requirements applicable to drug shortages and to the interruption and discontinuation of the sale of drugs in Canada.
How to Get Involved and Deadline
The consultation period is open for comments and suggestions for 90 days, starting June 30, 2016 until September 28, 2016.
- To request the document: Interested stakeholders who wish to provide comments may send a request for an electronic copy or alternate format of the document to DCVIU_UVCEM@hc-sc.gc.ca.
- Please include in the subject line, the title and the preferred language of the consultation document you wish to receive.
- To provide comments: Interested stakeholders may provide comments by email to DCVIU_UVCEM@hc-sc.gc.ca.
- Please include in the subject line, the title of the consultation document you are providing comments.
- Comments received from stakeholders will be reviewed after the 90 day comment period.
Reporting to Canadians
Health Canada will make the results of this consultation available on this website. Any questions or comments should be addressed to DCVIU_UVCEM@hc-sc.gc.ca.
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