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Order No. 187 of the National Sanitary Veterinary and Food Safety Authority validating the Veterinary Sanitary Regulation regarding the Code of veterinary medicinal products.

País/Territorio
Rumania
Tipo de documento
Reglamento
Fecha
2007 (2012)
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Sanidad animal Medicamentos Alimentos para animales/piensos Matanza Plagas/enfermedades Evaluación/manejo de riesgos Envasado/etiquetado Certificación Autorización/permiso Registro Comercio interior Acceso-a-la-información
Área geográphica
Mar Negro, Europa Oriental, Europa, Europa y Central Asia, Países de la Unión Europea
Resumen

National Sanitary Veterinary and Food Safety Authority validates the Veterinary Sanitary Regulation regarding the Code of veterinary medicinal products. Veterinary medical product shall be intended: (a) any substance or combination of substances intended for the treatment or prevention of animal diseases; and (b) any substance or combination of substances, which may be used or administered to animals for the restoration, correction or alteration of physiological functions, by the exercise of a pharmacological, immunological or metabolic action or to establish a medical diagnosis. The name of the veterinary medicinal product may be: (a) an invented which cannot be confused with common name; and (b) a common or scientific name accompanied by a trademark or the name of marketing authorization holder. This Order establishes packaging and labelling rules for veterinary drugs. The provisions of this Veterinary Sanitary Regulation shall apply to: (a) veterinary medicinal products; (b) premixes for medicated feed marketed in Romania, which are prepared industrially or by a method involving and industrial process; (c) active substances used as raw materials; and (d) substances that can be used as veterinary medicinal products with anabolic, anti-infective, anti-inflammatory, hormonal or psychotropic properties. The aforesaid veterinary products shall be marketed in Romania on the basis of a marketing authorization issued by the Institute for the Control of Biological Products and Veterinary medicines and must contain only authorized active substances. The application for obtaining marketing authorization shall be submitted for approval to the Institute for the Control of Biological Products and Veterinary and shall be accompanied by: (a) prospectus; (b) label; and (c) certificate of good manufacturing practice. The marketing authorization holder is responsible for the marketing of the veterinary medicinal product. If the health status of certain animals so requires, the National Sanitary Veterinary and Food Safety Authority may authorize the marketing or administration to animals of a veterinary medicinal product authorized in another Member State of the European Union, in accordance with this veterinary health rule. In case of serious epizootic diseases, the National Sanitary Veterinary and Food Safety Authority may provisionally authorize the use of immunological veterinary medicinal products, without marketing authorization, in the absence of veterinary medicinal products appropriate to the situation, only after informing the European Commission. The introduction into the country of unauthorized veterinary medicinal products is prohibited. A generic veterinary medicinal product authorized may be marketed as a generic veterinary medicinal product only after at least 10 years from the initial authorization of the reference product. Homeopathic veterinary medicinal products manufactured and marketed in Romania must be registered or authorized. The veterinary medicinal products authorized for marketing are registered in the National Register of veterinary medicinal products authorized in Romania and in the Nomenclature of veterinary medicinal products authorized in Romania. In order for the risk-benefit balance to be evaluated continuously, the Institute for the Control of Biological Products and Veterinary Medicinal Products may at any time request the marketing authorization holder to provide data demonstrating that the risk-benefit ratio remains favorable. The marketing authorization is valid for 5 years from the date of issue. The granting of the marketing authorization does not exonerate the manufacturer and, where applicable, the marketing authorization holder, from legal liability. Only persons authorized according to the provisions of the national legislation in force may possess or use veterinary medicinal products or substances that have anabolic, anti-infective, anti-parasitic, anti-inflammatory, hormonal or psychotropic properties. The owners or keepers of animals from which food is obtained must keep the documents relating to the purchase, possession and use of veterinary medicinal products in these animals for 5 years after administration, including for slaughtered animals. The authorization of veterinary medicinal products is not subject to the regulations on the tacit approval procedure.

Texto completo
Rumano
Página web
legislatie.just.ro