ГлавнаяDocumentsMedical product approval Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 9 Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation - Article 49. Documents Submitted to Customs Authorities of the Russian Federation when Importing Medicines into the Russian Federation
Article 49.Documents Submitted to Customs Authorities of the Russian Federation when Importing Medicines into the Russian Federation
1. When medicines are imported into the Russian Federation, the following documents shall be submitted to the customs authorities of the Russian Federation, in addition to the documentation provided for by the customs legislation of the Russian Federation:
1) certificate of manufacturer of a medicine stating that the imported medicine is in compliance with the pharmacopeia monograph or, failing the latter, with the normative documentation or normative document; 2) permit from an authorized federal executive body to import a specific consignment of medicine under the circumstances provided for in Clause 3 of Article 47 hereof.
2. The documents specified in Clause 1 sub-clauses 1 and 2 of this Article shall be submitted to the customs authorities of the Russian Federation on arrival of the medicines at the territory of the Russian Federation.