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Guidance documents on applications and submissions for drug products

Summary - Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales

From Health Canada

Overview

This guidance document provides information on the regulatory requirements for when

a drug is not sold for 12 or more months
the sale of a drug is discontinued
a Drug Identification Number (DIN) is cancelled

Who this guide is for

manufacturers of drugs

In this guide

1. Introduction
2. Purpose
3. Scope
4. Policy objectives
5. Definitions
6. Guidance for Implementation
6.1 Section C.01.014.6 Cancellation of a Drug Identification Number (DIN)
6.1.1 Section C.01.014.6 (1) (a): Cancellation Due to Discontinuation of Sale
6.1.2 Section C.01.014.6 (1) (c): Cancellation as Product is Not a Drug
6.1.3 Section C.01.014.6 (2) (a): Cancellation Due to Failure to Provide Annual Notification
6.1.4 Section C.01.014.6 (2) (b): Cancellation due to Concerns Regarding Safety and Efficacy
6.1.5 Section C.01.014.6 (2) (c): Cancellation following the suspension of a Notice of Compliance (NOC)
6.1.6 Section C.01.014.6 (3)
6.1.6.1 Section C.01.014.6 (3)(a) Cancellation following the failure to comply with the order to conduct an assessment and provide the results
6.1.6.2 Section C.01.014.6 (3)(b): Cancellation following the examination of the results of an assessment
6.1.7 Section C.01.014.6 (4)
6.2 Section C.01.014.7 Discontinuation Notification
6.3 Sections C.01.014.5(1)(a)(ii) and C.01.014.71 - 12 months without sale notification
6.3.1 Section C.01.014.5(1)(a)(ii) Reporting 12 months without sale on the Annual Drug Notification Form
6.3.2 Section C.01.014.71 Reporting 12 months without sale within 30 days
7. Consequences of the Drug Identification Number (DIN) Cancellation
8. Commercial Exportation
Appendices
Appendix A: List of Online Statuses
Appendix B: Glossary
Appendix C: References

View complete guide
Download PDF Version (295 KB, 19 pages)

Details and history

Published: March 14, 2017
Updated: May 30, 2018
Consulted: June 30, 2016
Part of topic: Guidance on legislation

For assistance

Our service hours are Monday to Friday from 8 a.m. to 6 p.m. (local time) and closed statuary holidays.

Contact us by email: HC.DIN.SC@canada.ca

Related guides and help

Drug Product Database
Guide to Reporting Drug Shortages and Discontinuations
Amendments to the Food and Drugs Act: Guide to New Authorities

Related acts and regulations

Food and Drugs Act
Food and Drug Regulations
Controlled Drug and Substances Act

Page details

2018-06-13

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