Centralized procedure for authorization of veterinary medicinal products

The centralized authorization procedure is governed by Regulation (EC) no. 726/2004 of the European Parliament and the European Council laying down Community procedures for the authorization and supervision of medicinal products (pharmaceuticals and immunological).The centralised procedure allows applicants to obtain a marketing authorisation that is valid throughout the EU. It is compulsory for medicinal products manufactured using biotechnological processes, for orphan medicinal products and for human products containing a new active substance which was not authorized in the Community before 20 May 2004 and which are intended for the treatment of AIDS, cancer,neurodegenerative disorder or diabetes. The centralized procedure is also mandatory for veterinary medicinal products intended primarily for use as performance enhancers in order to promote growth of treated animals or to increase yields from treated animals. The centralized procedure is optional for any other products containing new active substances not authorized in the Community before 20 May 2004 or for products which constitute a significant therapeutic,scientific or technical innovation or for which a Community authorization is in the interests of patients or animalhealth at Community level. When a company wishes to place on the market a medicinal product that is eligible for the centralizedprocedure, it sends an application directly to the European Medicines Agency, to be assessed by the Committee for Medicinal Products for Human Use (CHMP) or the Committee for Medicinal Products for Veterinary Use (CVMP). The procedure results in a Commission decision, which is binding on all EU Member States, to authorise the product.