Notice: Release of Guidance Document: Regulatory requirements for Drug Identification Numbers (DINs)

May 3, 2019
Our file number: 19-106654-60

The above referenced guidance document was released by Health Canada and is posted on the website.

This guidance document provides assistance on the interpretation of the regulatory requirements associated with a DIN. It provides guidance to manufacturers on their obligation to accurately report to Health Canada the following notifications for a change of drug status within the required timelines: Market notification, 12 months without sale notification, Discontinuation of sales notification.

This guidance document replaces the following documents:

• Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of Discontinuation of Sales
• Issuance of Drug Identification Numbers for New Drugs
• Notice: Instructions for filing Drug Notification Forms (DNF) and Supporting Documents Provided in Electronic Format
• Assignment of Drug Identification Numbers (DINs) According to Product Name
• Notice: Revision of the Procedure on the issuance of Drug Identification Numbers (DINs) for Unit Dosage Pre-filled Syringes
• ARCHIVED: Drug Identification Number: A Brand Name Product with Different Fragrances, Flavours or Colours

Comments received from the January 20, 2019, consultation on the notice regarding Regulatory requirements for Drug Identification Numbers (DINs) 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 the Office of Submissions and Intellectual Property.