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

Country/Territory
Russian Federation
Document type
Regulation
Date
2012 (2019)
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Animal health Drugs Business/industry/corporations Authorization/permit
Geographical area
Arctic, Asia and the Pacific, Black Sea, Caspian Sea, CIS (Commonwealth of Independent States), Eastern Europe, Europe, Europe and Central Asia, North Pacific, North-West Pacific
Abstract

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.

Full text
Russian
Website
pravo.gov.ru