Regulation amending the Regulation on veterinary medical products.

This Regulation makes amendments regarding the inspection of premises and equipment intended to be used for manufacturing operations and storage, the control of starting and finished products, and the registration of importer and exporter of veterinary medicinal products to the veterinary medicinal product tracking systems. This Regulation adds provisions and makes amendments about the GMP (Good Manufacturing Practices) for veterinary medicinal products regarding certification and inspection of national and foreign manufacturers. Moreover, production sites, analysis laboratories, packaging facilities and release sites that provide contractual services for veterinary medicinal products are also subject to GMP inspections by the Ministry. In case a serious situation occurs that would endanger human and animal health or violation of the provisions of this Regulation, the Ministry may cancel the permit for production sites, in whole or in part, for certain pharmaceutical forms, or cancel all of them until contradictions are resolved.