This Regulation sets out the necessary procedure for granting marketing and production authorizations for veterinary medicinal products. This text further determines the rules regarding the labelling of such veterinary medicinal products, their wholesale and retail or trade issues, related pharmacovigilance, monitoring of veterinary medicinal products and testing over the effective quality of veterinary medicinal products, as in accordance, and aimed at implementing the Law on veterinary medicinal products (published in the Official Gazette of the Republic of Croatia 84/2008). Articles 20, 21, 22, 23 and 24 are related to the rules as regards the special provisions applicable to homeopathic veterinary medicinal products; approval of a marketing authorization is in articles 25-35. Mutual recognition procedure and decentralized procedure are laid down in articles 36, 37, 38 and 39. Production and international trading relations and issues are in articles 40-53. This Regulation transposes the provisions of the Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products. The Annex is part of this publication (containing the complete list of technical requirements and adopted analytical methods).
كرواتيا · 2009-02-25