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List of Contact Points responsible for matters arising under CETA Good Manufacturing Practices Protocol

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

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

This Administrative Arrangement provides the List of contact points responsible for matters arising from the Administrative Arrangements set out in Article 15.3 of the Protocol to the Canada – European Union Comprehensive Economic and Trade Agreement between the European Union and Canada on the Mutual Recognition of the Compliance and Enforcement Programme Regarding Good Manufacturing Practices for Pharmaceutical Products (CETA GMP Protocol).

Article 15

3. The Joint Sectoral Group shall conclude a GMP Administrative Arrangement to facilitate the effective implementation of this Protocol. The GMP Administrative Arrangement shall include:

• a. the terms of references of the Joint Sectoral Group;
• b. the two-way alert programme;
• c. the list of contact points responsible for matters arising under this Protocol;
• d. the components of the information sharing process;
• e. the components of a good manufacturing practices compliance programme;
• f. the procedure for evaluating new regulatory authorities; and
• g. the equivalence maintenance programme.

2.   Purpose

This Administrative Arrangement provides the contact points of both Participants and facilitates the application of the Administrative Arrangements referred to in Article 15.3 of the CETA GMP Protocol.

3.   Scope

This list of contact points responsible for matters arising under this Protocol applies to:

• Regulatory Authorities listed in Annex 2 to the CETA GMP Protocol which were found equivalent after the initial confirmation pursuant to provisions of Article 12 Equivalence of new regulatory authorities of the CETA GMP Protocol.
• Regulatory Authorities that are legal successors of the authorities referred to in paragraph (1).
• Regulatory Authorities which were recognized as equivalent under the EU-Canada Mutual Recognition Agreement (MRA) of 14 May 1998 and which remained equivalent at the time of entry into force of the CETA.
• New regulatory authorities seeking recognition of their equivalency under Article 12 of the CETA GMP Protocol.

4.   Contact Points