Mutual Recognition Agreements

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This content applies to human and veterinary medicines.


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

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Related links

  • Australia: Fully operational
  • Canada: In operation, except for preapproval inspections and medicinal products derived from blood or blood plasma
  • Israel: Operational with some exclusions
  • Japan: Operational on 29 May 2004 - with limited scope
  • New Zealand: Fully operational
  • Switzerland: Fully operational
  • USA: In transition phase

Documents of interest

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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”

Useful Links

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