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.
Fédération de Russie · 2012-07-06