Components of the Information Sharing Process

Administrative Arrangement under Article 15.3(d) 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 Information Sharing Process is one of the main elements of the CETA 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 under Article 11 of the CETA GMP Protocol through an Administrative Arrangement pursuant to Article 15.3(d)(The Components of the Information Sharing Process).

This Administrative Arrangement sets out the operational arrangements to fulfil the requirements of Article 11.

Article 11

Two-way alert programme and information sharing

1.   A Party shall, pursuant to the two-way alert programme under the GMP Administrative Arrangement referred to in Article 15.3:

2. A Party shall, as part of the components of the information sharing process under the GMP Administrative Arrangement referred to in Article 15.3:

3. A Party shall provide the other Party, through written notification, contact points for each equivalent authority in its territory.

2.   Purpose

3.   Scope and Application

4.   Requesting and Providing Information

5.   Factors Affecting the Request

6.   Types of Information

7.   Confidentiality

8.   Administration

9.   Effective Date

This programme comes into operation on the date of its adoption by the Joint Sectoral Group on Pharmaceuticals.

Date Modified: