Saint-Petersburg customs: the import of drugs in the form of “in bulk”

Saint-Petersburg customs informs that from 1 July 2020 is mandatory marking by means of the identification of medicinal products for medical use. In accordance with part 4 of article 67 of the Federal law dated 12 April 2010 No. 61-FZ “On circulation of medicines” for the purposes of identification of packages of medicinal products for medical use requires the application of identification on primary packaging (in respect of medicinal products for medical use, for which there is no secondary package) and secondary (consumer) packaging of medicines in the procedure established by the Government of the Russian Federation, except for medicines manufactured for clinical trials, export, medicinal products specified in sections 5 and 8 of article 13 of this Federal law, radiopharmaceutical medicines, leeches medical and medical gases.

Medicines in the form of “in bulk” are not pre-packaged products. In accordance with the definition given in the order of the Ministry of industry and trade of Russia from 14.06.2013 № 916 “On approval of Rules of good manufacturing practice,” bulk products – any product that has undergone all stages of manufacturing process, except for consumer packages.

Thus, medicines in the form of “in bulk” can’t be applied as means of identification in connection with the absence of these products in consumer packaging.

In accordance with the Regulation on the import into the customs territory of the Eurasian economic Union pharmaceuticals approved by the Commission Board Decision of April 21, 2015 No. 30 and Rules for registration and examination of medicines for medical application, approved by the Decision of the Council of the Commission of 3 November 2016 No. 78, the import of medicines is performed on the basis of the information presented in the register of pharmaceuticals of the Union.

In the State register of medicines, available for free on the website provides information about medicines registered in packaging “in bulk”.

Thus, the import of drugs in the form of “in bulk” is possible without the application of means of identification, subject to the availability of records “in bulk” the registration certificate for a medicinal product and the State register of medicines.

The press service of the St. Petersburg customs