Equivalence Maintenance Programme

Administrative Arrangement under Article 15.3(g) 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 Equivalence Maintenance Programme is one 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 Parties, through the Joint Sectoral Group (JSG), are required to establish under Article 13 of the CETA GMP Protocol and through an Administrative Arrangement pursuant to Article 15.3(g)(Equivalence maintenance programme).

This Administrative Arrangement sets out the operational arrangements to fulfil the requirements of Article 13.

Article 13

Equivalence maintenance programme

2.  Purpose

In order to assure continued confidence in the status of equivalence between the Canadian and EU regulatory authorities (RA(s)), this Administrative Arrangement describes a system for regular confirmation of equivalence of the Participants’ GMP Compliance Programme. The components of the GMP compliance programme and its implementation by the RAs is established in this Administrative Arrangement.

3.  Scope

4. Definitions

For the purposes of this Administrative Arrangement:

Compliance means abiding by the laws, regulations and standards;

Equivalency means leading to the same result but does not mean identical;

Significant changes means changes that may affect the equivalency, especially those related to the following critical sub-components of the GMP compliance programme established under Article 15.3(e) of the CETA GMP Protocol

Minor changes mean changes, which do not affect equivalency.

5. Individual Roles

6. Maintenance Representatives

See Administrative Arrangement established under Article 15.3(c) List of contact points in charge for matters arising under the CETA GMP Protocol.

7. Elements and processes

The equivalence maintenance programme comprises four main elements:
a. Inclusion in the maintenance programme;
b. Maintenance and Re-confirmation of equivalence;
c. Training; and,
d. Exchange of information.

7.1. Inclusion in the maintenance programme

New RAs will be included in the maintenance programme following recognition of equivalence under Article 12 of the CETA GMP Protocol in accordance with the Administrative Arrangement under Article 15.3(f) Procedure for evaluating new regulatory authorities.

7.2.  Maintenance and  Re-confirmation

Participants will verify, at regular intervals, the continued fulfilment of the GMP Compliance Programme by their RAs. The Participants understand that the verification for maintenance and re-confirmation will consist of the following:

7.3.  Training

7.4.  Exchange of information

7.5   Deviation from equivalence

7.6   Regulatory Authorities deemed equivalent and subject to structural changes or reorganization

7.7   Oversight

7.8    Confidentiality

8. Effective Date

This Administrative Arrangement will become operational on the date of its adoption by the Joint Sectoral Group on Pharmaceuticals.

9. Appendices

A  Template for the Annual Report of the Equivalence Maintenance Programme
B  Template for reporting of major issues arising from the GMP Compliance Programme

 Appendix A

Example of contents of an Annual Report of the Equivalence Maintenance Programme

Country                          
Name of the Regulatory Authority        
Domain (human and/or veterinary) 
Coordinates of the Regulatory Authority
(Address, phone number, fax number, website, etc.)
 
Maintenance Representative - contact name and coordinates (Title, phone number, fax number, email, etc.)       
GMP Certificate contact name and coordinates
(Title, phone number, fax number, email, etc.)
 
Rapid-Alert System contact name and coordinates
(Title, phone number, fax number, email, etc.)
 
Reporting period 
Date of submission 

1. Follow-up to outstanding issues from previous Annual Report(s) and/or last desk-top re-evaluation and/or on-site re-assessment

2.  Significant changes to the GMP compliance programme during the reporting period.

3.  Changes to the GMP compliance programme, other than those related to critical sub-components (item 2 above), during the reporting period.

4.  Internal /external assessments received during the reporting period

5. Training
General information on training activities carried out

6.  Restructuring or reorganisation and impact on the Components of the GMP Compliance Programme (including planned reorganisation)

7.  Exchange of information (incl. rapid alerts, inspection planning, GMP certificates and inspection reports)

8.  Any comments or recommendations related to the maintenance programme
Issues/recommendations regarding the Two-Way Alert programme, certificate of GMP compliance, etc.

Report prepared by:
Name                          
Title                            
Address                      
Phone number             
Fax number                 
Email address              

Appendix B

Template for reporting of major issues arising from the GMP Compliance Programme

Date Modified: