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- Mutual Recognition Agreements
Overview
Mutual Recognition Agreements in relation to conformity assessment of regulated products include Sectoral Annexes on Good Manufacturing Practice for Human and Veterinary Medicinal Products.
The role of Inspections in the Pharmaceutical Annexes to these agreements:
- Contact point for information
- Co-ordination of implementation
- Co-ordination of maintenance activities
Table of contents
Status of MRAs, pharmaceutical Annex
Related links
- Australia: Fully operational
- Canada: In operation, except for preapproval inspections and medicinal products derived from blood or blood plasma
- Japan: Operational on 29 May 2004 - with limited scope
- New Zealand: Fully operational
- Switzerland: Fully operational
- USA: Not in operation
Documents of interest
| Document(s) | Language | Status | First published | Last updated | Effective Date |
|---|---|---|---|---|---|
| Mutual recognition agreements between the European Union and the respective parties Australia, Canada, New Zealand and Switzerland - Guide to the mutual recognition agreements in operation | (English only) | 05/05/2003 | |||
| Mutual recognition agreements: Sectoral Annex on Good Manufacturing practices - Issues related to Investigational Medicinal Products coverage from 1 May 2004 | (English only) | 05/05/2004 | |||
| Mutual recognition agreements EC - Switzerland: Questions and answers covering interpretation of Chapter 15, explanatory notes, Annex 16 and notice to applicants | (English only) | 18/12/2002 |
Related links
- An up-dated version of: Mutual recognition agreements: Sectoral Annex on Good Manufacturing Practices – Internationally Harmonised Requirements for Batch Certification has been published in Part 3 of Eudralex Volume 4 on the website of the European Commission under “MRA Batch Certificate”