Ecolex Logo
The gateway to
environmental law
Search results » Legislation

Governmental Decree No.1081 of 22 December 2011 validating the Regulation on licensing of pharmaceutical activities.

Country/Territory
Russian Federation
Document type
Regulation
Date
2011 (2017)
Source
FAO, FAOLEX
Subject
Livestock
Keyword
Institution Animal health Drugs Business/industry/corporations Authorization/permit Transport/storage Internal trade
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 business entities that would like to obtain a license to conduct pharmaceutical activities (they include wholesale and retail trade, storage and transportation of VMPs). The Federal Veterinary and Phytosanitary Supervision Service issues such licenses. The applicant must be in possession of the following requisites: (a) availability of premises and equipment required for the performance of pharmaceutical activities; (b) availability of medical organization – applicant’s license for the performance of pharmaceutical activities; (c) availability of the head of organization with at least 3-year secondary pharmaceutical education and 5-year working experience and expert’s certificate; and (d) 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