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Order No. 197 of the National Sanitary Veterinary and Food Safety Authority validating the Veterinary and Sanitary Regulation laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the European Community.

Pays/Territoire
Roumanie
Type du document
Règlement
Date
2006
Source
FAO, FAOLEX
Sujet
Bétail
Mot clé
Santé des animaux Médicaments Aliments pour animaux Hygiène/procédures sanitaires Transformation/manutention Transport/dépôt Normes Mise en application
Aire géographique
Mer Noire, Europe de l'Est, Europe, Europe et Asie Centrale, Pays de l'Union Européenne
Résumé

This Veterinary and Sanitary Regulation lays down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the European Community. It shall be applicable to the authorized medicinal premixes intended as any premix for the production of medicated feed placed on the market of the European Community for sale or assigned in any other form to third parties, free of charge of for fee, as well as the actual sale or assignment. As regards the medicinal component, medicated feedingstuffs may be manufactured only from authorized medicated premixes. The National Sanitary Veterinary and Food Safety Authority shall take all necessary measures to ensure that medicated feed is produced only under the following conditions: (a) the manufacturer must have premises approved in advance by the national competent authority, technical equipment and facilities appropriate storage and inspection facilities; (b) the medicated feed production facility must have staff with appropriate knowledge and qualifications in the field of blending technology; (c) the manufacturer must be responsible for ensuring that: (i) only feed or combinations thereof, which comply with Community provisions on feed, (ii) the feed used produces a homogeneous and stable mixture with the authorized medicinal premix, (iii) the authorized medicinal premix is used during the production process in accordance with the conditions laid down at the time of granting the authorization marketing and, in particular, that (iv) there is no possibility of undesired interaction between veterinary medicinal products, additives and feedingstuffs; the medicated feedingstuffs shall be kept for the authorized period; the feed to be used for the production of medicated feedingstuffs does not contain the same antibiotic or coccidiostat as those used as the active substance in the medicated premix; the daily ration of feed for treated animals or, in the case of ruminants, corresponds to at least half of the daily requirement of non-mineral supplements authorized in the ration; (d) the premises, personnel and equipment used throughout the production process must comply with hygiene rules , and the production process must comply with the rules of good production practice; to ensure that the feed comply with the provisions of this veterinary health standard, in particular as regards homogeneity, stability and storage; (f) manufacturers are required to keep daily records of the types and quantities of medicated premixes, authorized and used feed, as well as medicated feed products owned or delivered, together with the names and addresses of the breeders or owners of animals; and (g) the name and address of the authorized distributor and, where applicable, the name and address of the veterinarian who made the prescription.

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legislatie.just.ro