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

For assistance

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Fax: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca

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