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Request of the Ministry of Industry and Trade of Russia. Attention of pharmaceutical companies CEOs

Department of development of pharmaceutical and medical industry The Ministry of industry and trade (hereinafter – the Department) reports on amendments to the legislation of the Russian Federation concerning those companies which produce or have plans to produce their products to sell it on territory of Russia.

Failure to comply with the Law and Government regulations of the Russian Federation on the labeling of the drugs will lead to impossibility of production and putting into civil circulation in the territory The Russian Federation of medicines without marking means identification with crypto-code July 01, 2020, and for manufacturers of drugs included in the group of seven high-cost nosologies, from October 1, 2019 in accordance with the decree of the Government of the Russian Federation of December 14, 2018 № 1557 "On the peculiarities of the system implementation monitoring the movement of drugs for medical use". 

In addition, the Department reports that in accordance with the order First Deputy Minister of industry and trade of the Russian Federation S. A. Tsyba dated January 25, 2019 № CA-8 FBU "GILS and NP" instructed to collect information and inform all manufacturers of medicines (both Russian and foreign), as well as their representatives and holders of registration certificates on the implementation of the monitoring system in the Russian Federation, contact phone 8(495)676-4360, ext. 3312.

Based on the above, the Department kindly asks you to provide information about the implementation and(or) plans for the implementation of the drug labeling system using the crypto code until March 15, 2020, and then SEND this completed form on three sheets in tabular form with a cover letter on letterhead signed by the head of the Ministry of industry and trade of Russia by e-mail: markirovka@gilsinp.ru with the subsequent sending of the listed documents to the address: 123317, Moscow, Presnenskaya Naberezhnaya, house 10, building 2 (Tower 2, expedition). Next, you need to update and submit the form before the 15th day of each month.

If there are no plans for production and delivery to the Russian Federation of any medicinal product registered in Russia from each production site specified in the registration certificate by 2021, you must inform them by contact phone numbers 8 (495) 676-4340, 8 (495) 676-4340, ext. 3312 and send the relevant information by an official letter in Russian, signed by the company's Manager and (or) the owner of the registration certificate to the address: 123317, Moscow, Presnenskaya Naberezhnaya, house 10, building 2 (Tower 2, expedition) and by e-mail: markirovka@gilsinp.ru.

We will answer your questions, phones: +7 (495) 676-4340; +7 (495) 676-4360, ext. 3312 (Russian), 3142 (English).

 

 1 (*.xlsx, 33 Kb)

 2 (*.pdf, 2070 Kb)

 

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