Author: Simona Sturzu Affiliation: Institutul pentru Controlul Produselor Biologice si Produs medicinalelor de Uz Veterinar
Veterinary medicinal products that are subject to authorization via the centralized procedure according to Regulation (EC) no. 726/2004 are included in the Community register of veterinary medicines, that is published on the European Commission website and product information of them are published on the website of the European Medicines Agency. Each competent authority involved in the linguistic review process of product information annexed to the Marketing Authorization for medicinal products authorized centrally (SPC, leaflet, information about the marketing authorization holder, product labeling conditions), approve the version in the language mother of each Member State. In the second half of 2011 have received marketing authorization via the centralized procedure a total of four veterinary medicinal products, presented above.
Author: Simona Sturzu Affiliation: Institutul pentru Controlul Produselor Biologice si Produs medicinalelor de Uz Veterinar, Bucuresti
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 centralized procedure allows applicants to obtain a marketing authorization 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, neuro-degenerative 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 animal health at Community level.When a company wishes to place on the market a medicinal product that is eligible for the centralized procedure, 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 authorize the product.