Rules for interaction of operators with the traceability system of raw materials for drugs have been prepared

The companies that took part in the experiment are planned to be connected to the system automatically.

After registration, legal entities are offered to test their own software and hardware for the possibility of interaction with the state platform. Using data from the traceability system, regulators will check the country of origin of drugs to provide benefits under the national regime for public procurement.

From the moment of registration of a pharmaceutical manufacturer and until the receipt of a document containing information on the stages of drug production, including the synthesis of the active substance molecule of the active pharmaceutical substance (APS), in the territory of the EAEU, market participants will have to voluntarily transfer to the regulator information on the source materials and equipment used in the production of drugs. The Ministry of Industry and Trade plans to include in the list of such information, in particular, information on the source materials themselves, their acquisition and use, and on raw materials not sold in the territory of the Russian Federation.

The authors of the project also want to require companies that are not involved in the production of drugs, but are involved in the circulation of raw materials for pharmaceutical products, to register in the system and transfer data to regulators.

The Ministry of Industry and Trade proposes to revoke the document confirming the production of a medicine in the territory of the EAEU if the information system receives information about the production of a batch of the drug that, according to the Roszdravnadzor system or the system for monitoring the movement of medicinal products for medical use, is already in civil circulation. According to the draft, regulators will make a similar decision if thematic information is completely absent from the traceability system. The pharmaceutical company will be able to reissue the document after its revocation only after a year, the draft states.

In the explanatory note to the draft government resolution, the developers reported that the document was developed to implement the Pharma-2030 strategy, which "provides for the need to establish priority" for drugs from the list of strategically important drugs (SIL) produced in the EAEU. The document was also prepared during an "experiment, including taking into account the specifics of technological processes in the synthesis of active pharmaceutical substances." Public discussion of the project will last until July 15, 2025.

The Russian Government approved the resolution on conducting an experiment on the traceability of medicines and raw materials used for their production at the end of 2023. Initially, it was planned that the experiment would last from December 29, 2023 to December 31, 2024, but it was later extended until June 30, 2025. In April 2025, the completion date was postponed again - to August 31 of this year.

One of the most important tasks of the traceability system should be the verification of the real country of origin and the depth of localization of drug production. This data will affect the ability of pharmaceutical companies to receive benefits under the national regime, recorded in the government decree of December 2024. The provisions of the document, extending the "second extra" mechanism to state purchases of drugs, were criticized by the industry and patient communities. Specialized associations pointed out, among other things, the incorrect operation of the traceability system.