Centralised procedures are coordinated by the European Medicines Agency (EMA). The European Regulation (EC) No. 726/2004 applies for these marketing authorisation procedures. A centralised authorisation is then issued by the European Commission on the basis of a recommendation from the EMA for all states of the European Union (EU) and is also recognised by the states of the European Economic Area (EEA). A centrally authorised veterinary medicinal product can thus be marketed throughout the entire EU / EEA.
The centralised procedure is mandatory for all veterinary medicinal products listed in the Annex to European Regulation (EC) No 726/2004. In addition, an application for such an authorisation can be made for future veterinary medicinal products containing a new active substance and innovative new veterinary medicinal products (optional) at the EMA (see Article 3 (2) of Regulation (EC) No 726/2004).
The EMA itself has little scientific resources of its own. It therefore regularly uses the expertise of experts in national regulatory authorities when performing the scientific assessment of the quality, safety, environmental performance and efficacy of a veterinary medicinal product. For this purpose, it awards so-called rapporteurships and co-rapporteurships to the members of the Committee for Medicinal Products for Veterinary Use (CVMP) formed by the EMA. Rapporteur and co-rapporteur prepare the relevant scientific opinions on the respective veterinary medicinal products, which are then used as a basis for the decision on the authorisation by the European Commission.
The Paul-Ehrlich-Institut (PEI) is represented in the CVMP by a scientific staff member. Due to its proven expertise in the field of immunological veterinary medicinal products, the EMA often entrusts PEI with the preparation of scientific reports in the context of repeat reports and co-reports. The PEI is pleased to provide its years of experience from previous participations in centralised authorisation procedures forscientific advice on behalf of the EMA.
Furthermore, many experts of the PEI participate in the scientific working groups of the EMA in the preparation of guidelines and reports on specific issues concerning immunological veterinary drugs.
Extensive information on pharmaceutical legislation (for veterinary products) at a European level can be found on the websites of the Directorate General for Enterprise and Industry of the European Commission (EudraLex).