Mutual recognition agreements (MRA)

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 on the mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines.

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HumanVeterinaryCompliance and inspectionsRegulatory and procedural guidanceResearch and development
Supporting innovation

A range of services is available from the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and European Commission to support innovative medicines and associated technology developments in the European Union (EU).

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HumanVeterinaryRegulatory and procedural guidanceInnovationResearch and developmentScientific advice
Paediatric medicines: applications and procedures

Advice for applicants for paediatric medicines, including information on how to submit their applications, what templates and forms to use, the deadlines they need to meet, and the contact points they can reach out to.

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HumanPaediatricsResearch and development