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Governmental Decree No.686 of 6 July 2012 validating the Regulation on licensing the production of medicines.

Pays/Territoire
Fédération de Russie
Type du document
Règlement
Date
2012 (2019)
Source
FAO, FAOLEX
Sujet
Bétail
Mot clé
Santé des animaux Médicaments Commerce/industrie/sociétés Autorisation/permis
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 Governmental Decree provides requirements for pharmaceutical manufactures in order to obtain a license for medicines production. The Federal Veterinary and Phytosanitary Supervision Service issues licenses for VMP production. Licensing requirements for applicant shall be as follows: (a) of premises and equipment required for the performance of pharmaceutical activities; (b) compliance with good practices requirements and quality control of production; (c) availability of technical regulations, including data related to used pharmaceutical substances and additives; (d) availability of the head of organization 5-year higher pharmaceutical, chemical, medical or biological education and 5-year working experience; and (e) availability of medical staff on contractual basis. Annex I contains the list of pharmaceutical activities subject to mandatory licensing.

Texte intégral
Russe
Site web
pravo.gov.ru