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