Notice to stakeholders – Release of draft guidance document for consultation: Annex 3A to the Good Manufacturing Practices Guide 

October 7, 2020

Current status: Open

Health Canada is pleased to announce the release of Annex 3A to the Good manufacturing practices guide – Schedule C drugs (GUI-0026) for a 150-day stakeholder consultation period from October 7, 2020 to March 6, 2021.

This revised guidance document contains new information with key changes listed below.

This guide is an annex to the Good manufacturing practices guide for drug products (GUI-0001) and Good manufacturing practices (GMP) guidelines for active pharmaceutical ingredients (API) (GUI-0104). These guides are intended to be read together and will help you understand and comply with Part C, Division 2, of the Food and Drug Regulations (the Regulations), regarding good manufacturing practices (GMP).

How to participate

1. Obtain documents

Email to receive copies of the:

2. Submit comments

Email your comment form to or mail it to the address listed below. All comments will be considered in the finalization of the document. The consultation period is scheduled from October 7, 2020 to March 6, 2021.

Health Product Inspection and Licensing Division
Health Product Compliance Directorate
13th Floor, Jeanne Mance Building
200 Eglantine Driveway, Tunney's Pasture
Address Locator # 1913D
Ottawa Ontario K1A 0K9

Overview of Key Changes

Plain language changes

Key changes to the format and language of GUI-0026 include:

Technical changes


About this document

Section 4 – Modified interpretations

Appendix A

Appendix B

Page details

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