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

Pays/Territoire
Fédération de Russie
Type du document
Règlement
Date
2011 (2017)
Source
FAO, FAOLEX
Sujet
Bétail
Mot clé
Institution Santé des animaux Médicaments Commerce/industrie/sociétés Autorisation/permis Transport/dépôt Commerce intérieur
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 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.

Texte intégral
Russe
Site web
pravo.gov.ru