MR Procedure

In the Mutual Recognition (MR) procedure, a Member State recognises the assessment of the Member State in which the national authorisation for the veterinary medicinal product has already been granted. The competent authority of this so-called Reference Member State (RMS) prepares an updated assessment report on the quality, safety, environmental compatibility, and efficacy of the veterinary medicinal product and provides it to the Member States involved in the MR procedure (Concerned Member States, CMS). Furthermore, the RMS coordinates the procedure between the pharmaceutical company/applicant and the Concerned Member States. This is done in conjunction with the provisions of Regulation (EU) 2019/6.

Following completion of the MR procedure, the Paul-Ehrlich-Institut (PEI) grants a national marketing authorisation, if Germany is a Concerned Member State. If Germany is the RMS, the national marketing authorisation has already been granted for the product in question.

The advantage of the MR procedure is that the national authorisations are identical in all Member States that have been included in the procedure by the pharmaceutical company/applicant through relevant applications for authorisation. This significantly reduces the future administrative burden for the pharmaceutical company/applicant on the follow-up procedures to his national marketing authorisations.

A MR procedure that has once been performed may be followed by further procedures for mutual recognition by other Concerned Member States of the European Union (EU) or the European Economic Area (EEA).

Further information on the MR procedure is available on the joint websites of the national regulatory authorities in the EU, the Heads of Medicines Agencies (HMA). The Co-ordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv) regularly prepares and updates appropriate guidelines. These guidelines are also available on the HMA websites.

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