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Order No. 4 of the National Sanitary Veterinary and Food Safety Authority validating Veterinary Regulation on the manufacturing, processing, storage, transport, marketing and use of veterinary medicinal products and other veterinary products.

Country/Territory
Romania
Document type
Regulation
Date
2004
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Animal feed/feedstuffs Processing/handling Transport/storage Internal trade International trade Enforcement/compliance
Geographical area
Black Sea, Eastern Europe, Europe, Europe and Central Asia, European Union Countries
Abstract

This Veterinary Regulation establishes the conditions for the manufacturing, processing, storage, transport, marketing and use of veterinary medicinal products and other veterinary products contained in the Annex, which is an integral part of this document. Veterinary product shall be intended any veterinary medicinal product, including medicated premix, any veterinary dental product, veterinary cosmetic product, veterinary parapharmaceutical product, vitamin concentrate for veterinary use, veterinary biocidal product, veterinary diagnostic kit, vitamin supplement, vitamin-mineral and protein-vitamin-mineral, feed additive, as well as other veterinary products. Marketing of veterinary products shall be intended any activity that includes the purchase, sale, import, export or any other commercial transaction with a veterinary product, with or without profit. Marketing authorization shall be intended the permit granted to veterinary products to be marketed in Romania, if they have been authorized. The Central Veterinary Authority shall organize and coordinate the entire veterinary health activity, including approving the introduction into veterinary medical practice and controlling the movement of veterinary medicinal products/drugs and biological products, veterinary biocides and other veterinary products, manufactured in the country or imported thereto, required for the detection, prevention and control of animal diseases, ensuring in this respect their homologation and state control. Import and circulation of on the national territory of veterinary medicinal products without the authorization of the competent veterinary authority shall be prohibited. The units producing veterinary medicinal products, traders, as well as the units providing veterinary assistance must hold a copy of the Romanian Pharmacopoeia in force and the Nomenclature of pharmaceutical products for veterinary use registered in Romania and must comply, depending on the profile activity, with the provisions of the Veterinary Sanitary Regulation regarding the code referring to veterinary medicinal products. Units producing veterinary medicinal products, as well as those carrying out the division, packaging or conformation of such products, must comply with the rules of good manufacturing practice - GMP, laid down by the national legislation in force, and must obtain the certificate of good manufacturing practice.

Full text
Romanian
Website
legislatie.just.ro