Russia Signed Implementation Drug Labeling System Document

| By | Regulatory, Russian Pharma
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Dmitry Medvedev, The Chairman of the Government of the Russian Federation on 14 December 2018 signed the Orders about implementation in the territory of the Russian Federation the system of monitoring drugs movement with the use of means of identification.

Order No. 1556 approves the Regulation on the system of monitoring the movement of medicines for medical use (hereinafter – the Regulation).

The Regulation designates: the procedure of applying the means of identification, requirements for its structure and format, its characteristics; rules of creation, commissioning, operation and decommissioning of the monitoring system; the procedure for interaction of the monitoring system with other state information systems and information systems of legal entities and individual entrepreneurs engaged in the production, storage, import to Russia, dispensing, sale, transfer, use and destruction of medicines; the procedure of entering into the monitoring system and the composition of information on medicines; the procedure for providing the information contained in the monitoring system.

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Order No. 1557 establishes the specifics of the implementation of the monitoring system, including the timing of its implementation, with regard to medicines for medical use included in the list of vital and essential drugs (VED), as well as with respect to drugs for individuals hemophilia, cystic fibrosis, pituitary nanism, Gaucher disease, malignant neoplasms of lymphoid, hematopoietic and related tissues, multiple sclerosis, individuals after transplantation of organs or tissues, and other medicines for medical use. The implementation of a system of monitoring of such drugs due to their high social importance and procurement from the budget is a priority of the project. In particular, it was established that starting from October 1, 2019, the subjects of circulation of such medicines will have to enter information about medicines and all operations with them into the monitoring system.

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Order No. 1558 establishes the procedure for posting publicly available information contained in the monitoring system on the Internet (including in the form of open data). Public information will be posted on the website of the monitoring system by its operator. The Ministry of Health has the authority to approve the composition of publicly available information, the requirements for the periodicity of placement and the timing of updating the data set.