Components of Good manufacturing Practices Compliance Programme

Administrative Arrangement under Article 15.3(e) of the Protocol on the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products

This administrative arrangement is not intended to create rights or obligations under international or domestic law and, in line with Article 15(7) of the Protocol, is not subject of the provision of Chapter 29 of the CETA Agreement.

Between DG SANTE and Health Canada

Friday, November 16, 2018

DG Santé is a Directorate General of the European Commission.
Health Canada is a Federal department of the Government of Canada.

This administrative arrangement has been approved by the European medicines Agency (EMA) and the competent authorities of the Member States.

1. Introduction

The components of a good manufacturing practices compliance programme are part of the main elements of the CETA GMP Protocol to the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products (CETA GMP Protocol) which the Participants, through the Joint Sectoral Group (JSG), are required to establish through an Administrative Arrangement pursuant to Article 15.3(e) (GMP Compliance Programme).

2. Purpose

This Administrative Arrangement provides the components of a GMP Compliance Programme recognized by EU and Canadian Regulatory Authorities.  It represents the components on which a new Regulatory Authority (Article 12) will be evaluated to be formally recognized.

It also represents the components re-evaluated under the maintenance programme (Article 13) (partially or completely), in order to confirm the maintenance of an equivalent status.

3. Scope

This “Components of a Good Manufacturing Practice (GMP) Compliance Programme” (the Programme) applies to:

4.   Components of a GMP Compliance Programme

The above components are aligned with internationally harmonised standards and supplemented with details in the common audit checklist which is adopted individually by each participant.

For the EU: the latest version of the checklist, also referred to as Evaluation Guide for GMP Regulatory  Compliance Programme (Audit checklist), is available on the website of the European Medicines Agency.

For Canada: the latest version of the checklist is POL-0049, Mutual Recognition Agreement Evaluation Framework of Good Manufacturing Practices Compliance Programs, Appendix C- MRA Evaluation Guide and is available on the website of Health Canada.

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