Medicamentul Veterinar (Dec 2009)
Obtaining of the UE’s Fabrication Autorisation and of Good Manufacturing Fabrication Practice
Abstract
The harmonization of Romania’s legislation with the European Union’s one has as purpose the authentic equivalence archiving of the elaborated and applied measures on the Romania’s theritory with the ones legislated and applied in the other European Union state members.This is mandatory for the administrative procedure for the drow up of fabrication/import authorizations for the veterinary medicine products, in conformity with the European Commission published models and is assured in our country by the ANSVSA Presidents’ Order no. 57/2009, to the modification of the earlyer ANSVSA Presidents Order no. 187/2007 about the approval of the Veterinary Medicine Products Code, Sanitary Veterinary Norm, order which transponds the Commission Directive 2009/9/CE from 10th February 2009 and modiffying the Directive 2001/82/CE of the European Parliament and of the Council for the instituition of the Communitary code regarding the veterinary medicine products, published in the Official Journal of the European Union (JOUE) no. L 44 from 14th February 2009, which implements in the national legislations the authorizations for fabrication/ import communitary format for the veterinary medicine products,published by the European Commission in the Reglementation of the Veterinary Medicine Products Norms, volume 4, published in the Official Monitor Part 1, no. 611/08.09.2009.
