Post-Drug Identification Number (DIN) Changes Guidance Document

From Health Canada

Overview

All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a Drug Identification Number (DIN). After gaining authorization to market a drug a sponsor may for various reasons wish to make changes to the drug or the information associated with the drug. The guidance is intended to advise both internal and external stakeholders regarding the filing requirements for postmarket changes and the data recommendations to support those changes.

Who this guide is for

- Internal and external stakeholders

In this guide

1. Introduction
   • 1.1 Policy Objectives
   • 1.2 Policy Statement
   • 1.3 Scope and Application
   • 1.4 Background
2. Acronyms
3. Guidance For Implementation
   • 3.1 Reporting Categories
     • 3.1.1 Drug Identification Number (DIN) Application
     • 3.1.2 Notification (30 day)
   • 3.2 Filing Process
     • 3.2.1 Filing Process for Notifications
     • 3.2.2 Filing Process for Drug Identification Number (DIN) Applications
   • 3.3 Filing Information
     • 3.3.1 Related Guidances for Filing
     • 3.3.2 Other Related Guidances
     • 3.3.3 Pre-Submission Enquiries
4. Documentation
   • 4.1 Common Information for Notifications and DIN Applications
   • 4.2 Specific Information
     • 4.2.1 Changes to Information Captured by C.01.014.1(2) of the Regulations
       • 4.2.1.1 Changes outlined in C.01.014.1(2)(a)-(f):
       • 4.2.1.2 Changes outlined in C.01.014.1(2)(g)-(k):
       • 4.2.1.3 Changes outlined in C.01.014.1(2)(l)-(n):
     • 4.2.2 Other Changes Related to the Drug Authorization
5. Effective Date
6. Appendices
   • Appendix I: Excerpt from Food and Drug Regulations
   • Appendix II: DIN Submission Types - Pharmaceuticals for Human Use and Disinfectant Drugs
   • Appendix III: DIN Submission Types - Pharmaceuticals for Veterinary Use

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Details and history

Date adopted: 2013/12/19
Effective date: 2013/12/19
Part of topic(s): Guidance on legislation

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