Decentralised Procedure

The decentralised procedure (DCP) is based on the same basic idea as the mutual recognition procedure (MR procedure). Unlike the MR procedure, however, the decentralised procedure is not preceded by a national authorisation of the veterinary medicinal product. Instead, the pharmaceutical company/applicant 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.

In consultation with the applicant, 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 on behalf of the other participating Member States (Concerned Member States, CMS) takes on the scientific evaluation of the medicinal product and co-ordinates the procedure. This is done in conjunction with the relevant provisions of Regulation (EU) 2019/6. 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 applicant 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 applicant may apply for a subsequent recognition of the authorisation of the appropriate veterinary medicinal product in other EU/EEA Member States.

The Paul-Ehrlich-Institut 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 (CMDv) regularly prepares and updates the appropriate guidelines. These guidelines are also available on the HMA websites.

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