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Order No. 4 of the Ministry of Agriculture validating the Regulation on the procedure for the formation of a registration dossier for a medicinal product for veterinary use and the requirements for documents in its composition and the procedure for the submission of documents from which a registration dossier for a medicinal preparation for veterinary use is formed for the purposes of state registration.

Pays/Territoire
Fédération de Russie
Type du document
Règlement
Date
2018
Source
FAO, FAOLEX
Sujet
Bétail
Mot clé
Santé des animaux Médicaments Enregistrement Collecte de données/déclarations Accès-à-l'information
Aire géographique
Arctique, Asie et Pacifique, Mer Noire, Mer Caspienne, CEI (Communauté des États indépendants), Europe de l'Est, Europe, Europe et Asie Centrale, Pacifique Nord, Pacifique Nord Occidental
Résumé

This Order shall be applicable to the registration dossier for veterinary drugs submitted to the Federal Veterinary and Sanitary Supervision Service after the enactment of this Order. Registration dossier for veterinary drugs must contain the following documentation: (a) draft instruction for veterinary use of drugs; (b) information on pharmaceutical substances that compose drug; (c) data on medicinal preparation; (d) copy of the document in Russian language issued by the competent authority of the state of origin (manufacturing) of veterinary drug; (d) copy of compliance certificate issued to the manufacturer by the competent authority or copy of license for the manufacturing of veterinary drugs for the Russian manufacturers; (e) draft regulatory document related to veterinary drug; (f) report on preclinical testing of veterinary drug; (g) report on clinical testing of veterinary drug; (h) projected prototype of primary and secondary packaging of medicinal product; (i) copy of documentation related to availability or unavailability of registration data outside the territory of the Russian Federation; (j) consent in case of reproduction of existing veterinary drugs; and (k) copy of the document in Russian, certified in accordance with the established procedure and confirming the eligibility of the application for state registration of medicinal product (power of attorney).

Texte intégral
Russe
Site web
pravo.gov.ru