Notice: Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales

March 14, 2017
Our file number: 17-103104-439

The Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) (the Regulations) introduced, among other changes, a definition of the term "discontinue" in respect of the sale of a drug. In addition, the section requiring manufacturers to notify Health Canada within 30 days of the discontinuation of the sale of a drug, has been amended to specify the information that must be reported to Health Canada as part of this notification.

This guidance document provides assistance in interpreting sections of the Regulations that pertain to the cancellation of a DIN and the notification to Health Canada of the discontinuation of the sale of a drug. This guideline is designed to facilitate proper compliance by the manufacturers and to enhance consistency in the application of these regulatory requirements.

The guidance document is applicable to all drug products which have been issued a DIN pursuant to the Regulations.

Comments received from the June 29, 2016 consultation on the notice regarding Draft Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales were reviewed and considered in the finalization of this document. A summary of the comments received is available upon request.

This guidance document is effective immediately.

Questions related to this guidance document should be directed to:

Office of Submissions and Intellectual Property
Therapeutic Products Directorate, Health Products and Food Branch
Health Canada
Address Locator 0201A1
Finance Building, 101 Tunney's Pasture Driveway
Ottawa, Ontario  K1A 0K9

Telephone: 613-941-7281
Email: osip-bppi@hc-sc.gc.ca

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