UE organisms for the reglementation and market’s maintenance of veterinary use products

• Main Authors: Lolita Taban, Iuliana Moloiu
• Format: Article
• Language: English
• Published: Romanian National Association of the Veterinary Products Manufacturers 2009-12-01
• Series: Medicamentul Veterinar
• Online Access: http://www.veterinarypharmacon.com/docs/258-ART%203.pdf
• ISSN: 1843-9527; 2069-2463

Following the Romania's EU accession in 2007, national legislation licensing, distribution and circulation of veterinary medicinal products has been harmonized with relevant Community legislation, namely Directive 2001/82 amended by Directive 2004/28 and translated by Order of ANSVSA nr.187/2007 (which amended the Order ANSVSA nr.69/2005). Institute for the Control of Biological Products and Veterinary Medicines (ICBMV) is the competent authority in the licensing of veterinary medicinal products, working with European institutions, notably the European Medicines Agency (EMEA), in matters related to the licensing and post-marketing surveillance,together with ANSVSA. In the up mentioned context, ICBMV representatives attending to meetings of Working Groups of the CVMP (Committee for Medicinal Products for Veterinary Use) and the Coordination Group for Mutual Recognition production and decentralized procedure (CMDv), on different fields. Working groups are meeting in sessions, quarterly, and the CVMP and CMDv Committees meetings are held monthly, according to a timetable. By participating to the work meetings, the ICBMV representatives have the opportunity to improve their knowledge in them specific areas and to receive up to date information in the field of the veterinary medicinal products. Also, the information received is transmitted to the Romanian pharmaceutical industry for implementing the new UE requirements, to ensure an adequate level of quality, safety and efficacy in the field of veterinary medicinal products.