Post-Drug Identification Number (DIN) Changes Guidance Document

From Health Canada


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
  2. Acronyms
  3. Guidance For implementation
  4. Documentation
  5. Effective date
  6. Appendices

View complete guide

Download PDF (399 KB, 42 pages)

Details and history

Date adopted: 2009/12/19
Revised date: 2022/08/02
Effective date: 2022/08/02
Part of topic(s): Guidance on legislation

For assistance

Pharmaceutical Drugs Directorate
Director General's Office
Health Products and Food Branch
Address Locator: 3106B
Ottawa ON K1A 0K9
Telephone: 613-957-0368

Fax: 613-952-7756
Teletypewriter: 1-800-465-7735 (Service Canada)

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