%0 Journal Article
%T Elements of veterinary pharmacovigilance
%A Cristina
%A T. Romeo
%A Teusdea
%A V.
%A Paidac
%A S.
%J Medicamentul Veterinar
%D 2009
%I Romanian National Association of the Veterinary Products Manufacturers
%X In general sense, the main mission of a pharmacovigilance system is the drug safety monitoring after it¡¯s market approval and is mostly considered to be an important part of the activities under the guidance of EMEA and competent veterinary authorities. The Agency regularly receives reports from the Union but also from outside in terms regarding the products authorized centrally and coordinates the activities related to safety and quality of the medicinal products.The veterinary pharmacovigilance is monitoring the safety of veterinary use products, including vaccines, diagnosis or treatment of animal diseases after they reached the market, running all licensing procedures. To ensure ongoing safety of veterinary medicines is required the swift implementation of a National System of Pharmacovigilance where permanent improvements will have to consider the available data, based on lack of efficacy. The domain legislation recommends that where there yet are no data, the use ofapproved electronic means of communication of information relating to medicinal products marketed in the community. Centralized data for veterinary medicinal products in Romania can be achieved by The National Authority for Sanitary Veterinary and Food Safety of the Ministry of Agriculture and Food by Institute for the Control of Biological Products and Veterinary Medicines (ICPBMV).
%K veterinary pharmacovigilance
%K national
%K system EUDRA
%U http://www.veterinarypharmacon.com/docs/256-ART%201.pdf