Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINs) - Summary

From Health Canada

Overview

This guidance document provides:

1. assistance on the interpretation of the regulatory requirements associated with a DIN
2. 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 sale notification

In this guide

• 1. Introduction
• 2. Purpose
• 3. Scope
• 4. Policy objectives
• 5. Definitions
• 6. Guidance for implementation
  • 6.1 DIN issuance
    • 6.1.1 The timing of DIN issuance
    • 6.1.2 Assignment of DIN according to product name
    • 6.1.3 Issuance of multiple DINs to address safety issues
  • 6.2 Drug statuses and the Drug Product Database
  • 6.3 Market notification
    • 6.3.1 Completing the market notification
  • 6.4 Twelve months without sale notification - dormant status
    • 6.4.1 Reporting 12 months without sale within 30 days
    • 6.4.2 Reporting 12 months without sale for all drugs on the Annual Drug Notification form
    • 6.4.3 Recommencing sale after being dormant
  • 6.5 Discontinuation of sale notification
    • 6.5.1 Discontinuing after being dormant
  • 6.6 DIN cancellation
    • 6.6.1 Cancellation due to safety issue
    • 6.6.2 Cancellation due to failure to provide annual drug notification - C.01.014.6 (2) (a) of the Food and Drug Regulations
    • 6.6.3 Cancellation as product is not a drug - C.01.014.6 (1) (c) of the Food and Drug Regulations
  • 6.7 Required activities following the cancellation of a DIN
  • 6.8 Reissuance of a DIN by Health Canada
  • 6.9 Commercial exportation
    • 6.9.1 Exportation without invoking Section 37
    • 6.9.2 Exportation under Section 37
  • 6.10 Submitting notifications to Health Canada
    • 6.10.1 Document requirements
    • 6.10.2 Format and filing instructions
  • 6.11 Contact us
• Appendix A Template email - Request for DIN reissuance

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Details and history

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DIN@hc-sc.gc.ca