Mutual recognition agreements

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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:

Documents of interest

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