State Register of Medicines

History

2022: Transfer of the state register of drugs to the Uniform State Health Information System for 190 million rubles

In November 2022, the Ministry of Health of the Russian Federation announced a tender for the transfer of the State Register of Medicines (GRLS) to the platform of the Unified State Information System in the field of healthcare (Uniform State Health Information System). The department is ready to pay up to 189.8 million rubles for this project. The contractor will be selected by November 11, 2022.

According to the terms of reference, the "drug" subsystem in the Uniform State Health Information System should contain a register of registered drugs, a state register of the maximum selling prices of manufacturers for drugs from the list of vital and essential drugs, the list itself, as well as a register of issued permits for clinical trials. On their basis, a single structured directory-catalog of drugs will be formed, which is planned to be used, including for the formation of a catalog for public procurement of drugs. The handbook will be public.

The Ministry of Health transfers the state register of drugs to the Uniform State Health Information System for 190 million rubles

At the expense of the subsystem, the Ministry of Health will automate the provision of public services in the field of registration and circulation of drugs. According to the terms of the tender documentation, no later than December 15, 2022, it is necessary to develop software, carry out commissioning of the subsystem, and conduct its preliminary tests. By June 30, 2023, the launch of a new subsystem and the decommissioning of the current information system should be completed.

The first stage of work - until December 15, 2022 - is estimated at 159.8 million rubles, the second stage - at 30 million rubles.

The following information is provided in the State Register of Medicines:

• Marketing authorization number;
• Date of registration;
• Expiration date of the marketing authorization;
• Date of cancellation of the marketing authorization;
• Legal entity in whose name the marketing authorization has been issued;
• Trade name of the medicinal product;
• International non-proprietary or chemical name;
• Release Forms;
• Information on production stages;
• Barcodes of consumer packaging;
• Regulatory documentation;
• Pharmaco-Therapeutic Group.^[1]

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