In the Mutual Recognition Procedure (MRP), the Paul-Ehrlich-Institut (PEI) grants a national marketing authorisation pursuant to the Animal Health Act (TierGesG) and the Animal Vaccine Regulation. This is done in conjunction with the relevant provisions of European Directive 2001/82 / EC (Community Code on Veterinary Medicinal Products).
In the MR procedure, a Member State recognises the examinations and assessments of the Member State in which the authorisation for the veterinary medicinal product was first granted. The competent authority of this so-called Reference Member State (RMS) provides its assessment reports on the quality, safety, environmental compatibility, and efficacy of the veterinary medicinal product to the Member States involved in the MR procedure (Concerned Member States, CMS). Furthermore, the RMS coordinates the procedure between the pharmaceutical entrepreneur and the participating Member States.
Following completion of the MR procedure, identical authorisations will be granted in all Member States that have been included in the procedure by the pharmaceutical company through relevant applications for authorisation. This significantly reduces the future administrative burden for the pharmaceutical company on the follow-up procedures to his national marketing authorisations.
A MR procedure that has once been performed may be followed by further MR procedures for obtaining a marketing authorisation in other member states of the European Union (EU) or the European Economic Area (EEA).
The PEI has successfully completed a variety of mutual recognition procedures as RMS since the introduction of this type of procedure. It provides its long experience concerning this in the appropriate consultations.
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 - Veterinary, CMDv regularly prepares and updates appropriate guidelines.
Comprehensive information on (animal) pharmaceutical legislation at a European level can be found on the websites of the Directorate-General Enterprise and Industry of the European Commission (EudraLex).