According to the new Resolution of the Government of the Russian Federation No. 1954, all participants in the medicines turnover should register in the labelling system from January 1 to the end of February 2020. From July 1, 2020 the circulation of medicines without digital codes will be prohibited.
Amendments to the Resolution of the Government of the Russian Federation No. 1556 “On Approval of the Regulation on the System for Monitoring of Medicines Turnover for Medical Use” came into force. They are a regulatory document for the adopted law on the phased implementation of labelling from January 1 to July 1, 2020.
The corresponding Resolution of the Government of the Russian Federation No. 1954 on amendments to the Resolution No. 1556 was published on January 9, 2020 on the website pravo.gov.ru. The Prime Minister Dmitry Medvedev signed the document on December 31, 2019.
According to the document, by February 15, 2020 all medical institutions are to submit an application to the Centre for Development of Advanced Technologies to obtain a registrar for medicines withdrawal. Manufacturers and importers must submit an application for the emission registrar by May 1, 2020.
Starting from July 1, 2020 the production and import of unlabelled medicines will be prohibited, and transfer of information on turnover of labelled medicines to the labelling system becomes mandatory for all the participants. The sale of unlabelled drugs that entered into circulation before July 1, 2020 is allowed until the expiration of their shelf life.