The Russian Ministry of Industry and Trade has drafted a bill that could change the procedure for issuing documents confirming the stages of the technological process involved in manufacturing medicinal products within the Eurasian Economic Union (EAEU). Instead of issuing a paper or individual document, the proposal calls for the relevant information to be entered into a dedicated register, from which manufacturers would be able to obtain an extract. At the same time, the ministry intends to grant itself the authority to remove entries from the register if violations are identified.
The document confirming manufacturing stages plays a key role in verifying pharmaceutical localization for participation in public procurement. In particular, it is used under the “second one out” mechanism, which restricts foreign medicines from participating in tenders when products manufactured within the EAEU are available. According to the Ministry of Industry and Trade, the importance of this document will increase significantly from July 2026, when it is expected to replace certificates issued by the Chamber of Commerce and Industry as the primary means of confirming the origin of medicinal products.
To verify the accuracy of the submitted information, the ministry plans to use data from the pharmaceutical and raw material traceability system established on the basis of the state product labeling system. Manufacturers will be required to demonstrate that the declared manufacturing stages correspond to actual data on the movement of raw materials and finished products, including material balances and production loss indicators. The Ministry of Industry and Trade notes that this mechanism is necessary to prevent misuse of the document, including attempts to obtain advantages in procurement procedures.
The explanatory note also emphasizes that the number of applications for documents confirming manufacturing stages is growing rapidly. In 2018, 72 applications were submitted; by 2025, the number had reached 909, or 1,112 when repeat reviews were included. Once the new rules for confirming the origin of medicines take effect, the ministry estimates that the volume of applications could increase more than elevenfold, to 9,500 applications annually, or more than 700 per month.
Against the backdrop of the expected increase in workload, the bill provides for the possibility of involving the State Institute of Drugs and Good Practices (SID & GP), an institution subordinate to the Ministry of Industry and Trade, in the review process. The institute would be authorized to assess applicants’ materials, with decisions on whether to include information in or remove it from the register made on the basis of its findings. The ministry believes that this approach will make it possible to maintain current application processing times without increasing its staffing levels or introducing additional fees for pharmaceutical manufacturers.
Implementation of the initiative will require amendments to a number of secondary regulations, including the Regulation on the Ministry of Industry and Trade and the list of mandatory expert reviews required for the provision of public services. A new procedure for maintaining the register and new administrative regulations governing the provision of the service will also need to be developed.
In March 2026, the Ministry of Industry and Trade drafted a new Regulation on the Licensing of Pharmaceutical Manufacturing. The document provides for shorter licensing timeframes, clarifies personnel requirements, and introduces separate provisions for manufacturers of medical gases, radiopharmaceuticals, and veterinary medicines. The draft also establishes a requirement for medicines to be physically manufactured using a company’s own technological equipment, which is linked to localization confirmation and the application of the national preference regime in public procurement.
Source: Vademecum, June 15, 2026.
