This content applies to human and veterinary medicines.
The European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex concerning the mutual recognition of good manufacturing practice (GMP) compliance for human and veterinary medicinal products.
The aim is to allow EU authorities and their counterparts to:
- rely on each other's GMP inspections;
- waive batch testing of products on entry into their territories;
- share information on inspections and quality defects.
The scope of each agreement differs.
Status of MRAs (pharmaceutical annex)
The country links below provide further information on the scope and status of individual MRAs:
- Australia: fully operational
- Canada: in operation, except for pre-approval inspections and medicinal products derived from blood or blood plasma
- Israel: operational with some exclusions
- Japan: operational with limited scope
- New Zealand: fully operational
- Switzerland: fully operational
- United States (US): in transition phase
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)||2003-05-05|
|Mutual recognition agreements: Sectoral Annex on Good Manufacturing practices - Issues related to Investigational Medicinal Products coverage from 1 May 2004||(English only)||2004-05-05|
|Mutual recognition agreements EC - Switzerland: Questions and answers covering interpretation of Chapter 15, explanatory notes, Annex 16 and notice to applicants||(English only)||2002-12-18|
- In 2011, an updated version of Internationally harmonised requirements for batch certification was published in Part 3 of Eudralex Volume 4 - GMP guidelines.
- European Commission: mutual recognition
- European Commission: trade