Member Article

As of July 1, the Russian requirements on digital labelling of medications and transmitting the data on medications’ turnover to the Chestny ZNAK system have become mandatory.

Start of mandatory digital labelling

From 1 July, all market participants of the pharmaceutical industry (manufacturers, distributors, pharmacies, etc.) must reflect information on all operations made with medications in the monitoring system.

Failure to transmit the data to the track & trace system or transmission of inaccurate information regarding the medications, production, sale of unlabeled medications will result in administrative liability in the form of an administrative fine for legal entities (from RUB 50,000 up to RUB 300,000) along with possible seizure of unlabeled medications. Besides, if the authorities consider it a grave violation of license requirements, they may administratively suspend legal entity’s operations for the period up to 90 days. Grave violation of license requirements takes place in case of failure to comply with requirements on registration in the track & trace system, transmitting information on the medications’ turnover, applying of mandatory labelling.

New procedure for releasing unlabeled products into turnover

At the same time, the procedure for putting unlabeled medications into the market established by the Resolution of the Government of the Russian Federation No. 955 dated June 30 (in force until January 1, 2021) (“Resolution”) which was published on July 1.

Besides, on July 13, 2020, the President of Russia signed the bill No. 902457-7 (“Amendments”) amending Article 67(7.1) of Federal Law No. 61-FZ dated April 12, 2010 “On Turnover of Medications” and thus authorizing the Russian Government to provide for details of marketing of medications produced during the period from July 1, 2020, till October 1, 2020. Though the Resolution was adopted before the Amendments entered into force, the Russian legislature coordinated the law with executive regulation. Therefore, currently, the Resolution and the Amendments supplement each other and have full legal force.

The Resolution states that medications produced in Russia from July 1 until October 1, 2020, as well as the ones produced outside of Russia before October 1, are marketed according to a decision of a specially created interdepartmental commission established by the Russian health supervisory authority (“RZN”). Certain medications do not fall under this special procedure: pursuant to the Resolution, medications that are meant for people after organ and/or tissue transplantation or for people with the following diseases are excluded from its scope:hemophilia,cystic fibrosis,pituitary nanism,Gaucher's disease,malignant neoplasms of lymphoid, hematopoietic and related tissues,multiple sclerosis.

Obtaining a permit for turnover of unlabeled medications

A permit for the marketing of the unlabeled medications is issued for 45 calendar days and free of charge. In order to obtain the permit, it is necessary to file an application in electronic form and attach the annexes stated in the Resolution using a personal account in RZN’s automated information system. The application is considered within 10 business days. Information on the permits issued will be made available in a special register, which will be located on the RZN’s official website.

An application for a permit must be accompanied by a number of documents completed in or translated into the Russian language, among others:

• copies of the documents in Russian of a marketing authorization holder, which confirm the applicant’s authority to submit documents for obtaining the permit,
• reasons for the inability to label medication packages,
• copies of documents for the delivery and installation of labelling equipment at each of the production sites specified in the application, as well as for the development or refinement of software interacting with the monitoring system,
• action plan to implement the monitoring system (please note that it is necessary to specify the final date when the producer is ready to apply QR codes to the packages and to transfer this data to the monitoring system).