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Governmental Decree No. 565 On the procedure for submitting documents and information on medicinal products for veterinary use introduced into civil circulation, issuing permission to enter into civil circulation an immunobiological medicinal product for veterinary use and test reports on the compliance of batches of an immunobiological medicinal product for veterinary use with the quality indicators provided for by the regulatory document.

Pays/Territoire
Fédération de Russie
Type du document
Règlement
Date
2023
Source
FAO, FAOLEX
Sujet
Bétail
Mot clé
Santé des animaux Médicaments Transformation/manutention Autorisation/permis Collecte de données/déclarations Accès-à-l'information Transport/dépôt Commerce international Mise en application
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
Entry into force notes
This Governmental Decree enters into force on 1 September 2023.
Résumé

Rules for submitting documents and information about medicinal products for veterinary use introduced into civil circulation establish the procedure for submitting to the Federal Service for Veterinary and Phytosanitary Surveillance documents and information about each batch of a medicinal product for veterinary use produced in the Russian Federation or each batch imported (transported) into the Russian Federation of a medicinal product introduced into civil circulation on the territory of the Russian Federation, with the exception of immunobiological medicinal products, by manufacturers of medicinal products and organizations importing (transporting) medicinal products into the Russian Federation. Rules for issuing a permit to put into civil circulation an immunobiological medicinal product for veterinary use establish the procedure for issuing a permit by the Federal Service for Veterinary and Phytosanitary Surveillance to put into civil circulation an immunobiological medicinal product for veterinary use manufactured in the Russian Federation or imported (transported) into the Russian Federation. Rules for issuing test reports on the compliance of batches of an immunobiological medicinal product for veterinary use with the quality indicators provided for by the regulatory document establish the procedure for issuing test reports on the compliance of batches of an immunobiological medicinal product for veterinary use with the quality indicators provided for by the regulatory document.

Texte intégral
Russe
Site web
publication.pravo.gov.ru