De­cen­tralised Pro­ce­dure

The decentralised procedure (DCP) is based on the same basic idea as the mutual recognition procedure (so-called MR method). Unlike the MR procedure, however, the decentralised procedure is not preceded by a national authorisation of the veterinary medicinal product. Instead, the pharmaceutical company applies for a marketing authorisation in all the Member States of the European Union (EU) or the European Economic Area (EEA) in which it desires to market the product. Following completion of the decentralised procedure, the Paul-Ehrlich-Institut (PEI) issues a national authorisation under the Animal Health Act (TierGesG) and the Animal Vaccine Regulation in conjunction with Directive 2001/82 / EC (Community Code on Veterinary Medicinal Products).

In consultation with the pharmaceutical company, one of the Member States involved in the decentralised procedure assumes the role of the so-called Reference Member State (RMS). The competent authority of the RMS acts on behalf of the other participating Member States (Concerned Member States, CMS) takes on the scientific evaluation of the drug and co-ordinates the procedure. If all participating Member States (RMS and CMS) agree to the authorisation being granted, this decision will form the basis of their respective national marketing authorisations.

The decentralised procedure, like the MR procedure, has the advantage that the pharmaceutical company receives identical marketing authorisations for its veterinary medicinal product in all participating Member States. This leads to a significant reduction in the future administrative burden in relation to the follow-up procedures of the national authorisations.

Following a decentralised procedure, the pharmaceutical company may later on apply via a MR procedure for an authorisation of the appropriate veterinary medicinal product in other EU / EEA Member States.

The PEI gladly provides its years of experience from the European marketing authorisation procedures that have been carried out so far for appropriate consultations.

Further information on the decentralised 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 (CMD v) regularly prepares and updates the appropriate guidelines.

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).

Updated: 21.11.2019