Authorisation procedures for veterinary medicinal produscts and application types

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; t...

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Bibliographic Details
Main Authors: Alina Karina Draghici, Lollita Taban
Format: Article
Language:English
Published: Romanian National Association of the Veterinary Products Manufacturers 2009-12-01
Series:Medicamentul Veterinar
Subjects:
Online Access:http://www.veterinarypharmacon.com/docs/262-ART%207.pdf
Description
Summary: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 57/2009 Order 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 product authorization's process stages as well the possible authorization's application type versions.
ISSN:1843-9527
2069-2463