The reregistration of veterinary medicinal products in Hungary

Citation
S. Bernath et al., The reregistration of veterinary medicinal products in Hungary, MAGY ALLATO, 123(1), 2001, pp. 47-50
Citations number
16
Categorie Soggetti
Veterinary Medicine/Animal Health
Journal title
MAGYAR ALLATORVOSOK LAPJA
ISSN journal
0025004X → ACNP
Volume
123
Issue
1
Year of publication
2001
Pages
47 - 50
Database
ISI
SICI code
0025-004X(200101)123:1<47:TROVMP>2.0.ZU;2-1
Abstract
The marketing authorisations of veterinary medicinal products are valid for five years in Hungary, The validity of the Licence may be extended by a re newal procedure upon request from the authorisation holder for further five -year periods, The application for renewal should be filed to the Ministry of Agriculture and Rural Development six months before the expiration of th e validity of the current marketing authorisation, In the revision, the ren ewed dossier, the results of the state quality control of medicinal product s' samples taken from trade, and in case of notification arriving to the ph armacovigilance, the experiences of the case, are assessed The regulations of the European Union and the data of scientific literature are also taken into account, The objective of the process is to ensure that only the produ cts of a consistently high quality, safety and efficacy remain on the marke t, Veterinary medicinal products with expired marketing authorisation or re jected application for renewal shah be withdrawn from circulation by the en d of the same year when the marketing authorisation expires, The revision c ontributes to the constant modernisation of the marketed medicinal products and to the withdrawal of outdated products from the market.