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

País/Territorio
Federación de Russia
Tipo de documento
Reglamento
Fecha
2011 (2017)
Fuente
FAO, FAOLEX
Materia
Ganado
Palabra clave
Institución Sanidad animal Medicamentos Negocios/industria/corporaciones Autorización/permiso Transporte/depósito Comercio interior
Área geográphica
Ártico, Asia y Pacifico, Mar Negro, Mar Caspio, CEI (Comunidad de Estados Independientes), Europa Oriental, Europa, Europa y Central Asia, Pacífico Norte, Pacífico Nordoeste
Resumen

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.

Texto completo
Ruso
Página web
pravo.gov.ru