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 sales notification

In this guide

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