Mutual Recognition Procedure

Upon completion of a mutual recognition procedure (MRP), the concerned Member States (CMS) recognise an authorisation which was initially granted by another Member State of the European Union. This state is referred to as the reference member state (RMS) and provides the assessment report (AR) on which the procedure is based.

Dossier Requirements

In order for the RMS to draft the assessment report for the procedure, the applicant updates the documentation underlying the existing national marketing authorisation in the RMS. For more information, please be referred to the Best Practice Guide for mutual recognition procedures on the CMDv Website.

Preparation of an assessment report (AR)

Upon receipt of the updated dossier, the RMS prepares an assessment report (AR) within a period of 90 days.

Validation phase

Before the start of the actual MR procedure, a validation phase of 15 days, during which the CMS check whether the application for authorisation is valid and complete, is foreseen.

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Mutual recognition procedure

The Coordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv) publishes a list of start dates on the HMA homepage (clock start dates). The CMS recognise the authorisation by day 90 of the ongoing procedure, unless a member state identifies a potential risk to human or animal health or to the environment.

Granting the authorisation

Once the authorisation has been recognised as part of this procedure, the applicant submits translations of the product literature in the language of the respective member state (CMS) within 6 months. The national competent authority then issues the marketing authorisation within 30 days of receiving the high quality translations.
In accordance with Regulation (EU) 2019/6 the Union Product Database has been developed for information on veterinary medicinal products available in the Member States. You can access the UPD here.

An overview of preparations authorised via the decentralised procedure in the participating member states can also be found on the HMA homepage under VMRI Product Index.

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Charging of fees

The information on fees be found in section 6a, table 1 of the Special Fee Ordinance of the Federal Ministry of Health for individually attributable services in its area of responsibility (Special Fee Ordinance BMG - BMGBGebV – German only).

The fees are charged by invoice after the marketing authorisation procedure has been concluded.
More information on the Special Fee Ordinance can be found here.

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