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Mutual recognition (MR)

A community registration procedure described by Council Directive 75/319/EEC (as amended) for the authorisation of medicinal products. Mutual Recognition Procedure: One of the routes for seeking regulatory approval in the European Union. A submission is first made to a EU Member State authority that assesses, grants a national approval and prepares an assessment report. This report is circulated by the initial authority to the other (concerned) Member States who are expected to recognize this decision and grant their own national authorisation within a period of 90 days following the initial approval. The 90-day period is used to resolve any issues between Member States. If serious objections are raised then the application is referred to the CHMP for arbitration leading to a binding decision.

Note: Concerned Member State: A Member State that is concerned (i.e. included in the mutual recognition phrase) with an application for Mutual Recognition, and expected to recognize the initial approval of the Reference Member State.