Ema Mra Agreements

The European Union (EU) has signed mutual recognition agreements (MRAs) with third country authorities on conformity assessment of regulated products. These agreements contain a sectoral annex on the mutual recognition of GMP (Good Manufacturing Practice) inspections and the certification of batches of medicinal products for human and veterinary use. These agreements benefit regulators by reducing double inspections in any other area, allowing for a greater focus on higher-risk sites, and expanding inspection coverage of the global supply chain. MRAs are trade agreements aimed at facilitating market access and promoting greater international harmonization of compliance standards while protecting consumer safety. .