Authorisation procedures for veterinary medicinal produscts and application types

Authors: Alina Karina Draghici, Lollita Taban                                                                                 Affiliation: Institutul pentru Controlul Produselor Biologice si Medicamentelor de Uz Veterinar, Bucuresti

The authorization process of veterinary medicinal products is an complex and laborious process, which is accomplished through multiple stages and by centralized procedures, communitary or nationals in the respect of 2001/82/EC Directive amended by the 2004/28/EC Directive; the 726/2004 Regulation; the Order no. 57/2009 and by the specific Guidelines. The Assessor is a person who has the right to recommend the granting or denial of veterinary medicine products marketing authorization. In the paper are presented the veterinary medicine products authorization process stages as well the possible authorizations application type versions.

full text (in Romanian)

Obtaining of the UE’s Fabrication Autorisation and of Good Manufacturing Fabrication Practice

Author: Rodica Morcov                                                                                                                   Affiliation: A.N.S.V.S.A. Bucuresti

The harmonization of Romanian legislation with the European Union’s one has as purpose the authentic equivalence archiving of the elaborated and applied measures on the Romanian 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 earlier 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 modifying the Directive 2001/82/CE of the European Parliament and of the Council for the institution 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.

full text (in Romanian)