The Ministry of Industry and Trade of the Russian Federation initiated amendments to Federal Law No. 61 – FZ concerning order confirmation stages production medicinal drugs . According to proposal , instead of issuance separate document corresponding intelligence will be be contributed directly V state registry . Project located on public discussion until July 3 , 2026 .
The essence of the changes
Currently, confirmation of production stages’ compliance with the registration dossier is issued as a separate document. The Ministry of Industry and Trade proposes replacing this practice with a registry-based model, which would:
– information about sites, addresses, stages of synthesis and release of the finished form will be recorded in the register of medicines or a specialized register associated with it;
– the fact of registration in itself becomes confirmation of the legitimacy of the production chain.
Thus, instead of a one-time permitting procedure, a continuous registry accounting is introduced, allowing for changes to be quickly reflected and more accurately match the actual production configuration.
Practical significance
Confirmation of production stages (CP) is key to proving the full production cycle within the EAEU. The registry model pursues several objectives:
– Access to government support and procurement – being registered in the registry grants access to support measures from the Ministry of Industry and Trade and is mandatory for participation in government procurement.
– Linking with the “second wheel” mechanism: for strategically important drugs, priority will be given to manufacturers with high localization, confirmed by a registry entry.
– Combating violations – linking to a traceability system allows us to identify cases of using imported raw materials under the guise of localized products.
– Accelerated application processing—the registry model reduces processing times for bona fide producers and eliminates loopholes for unscrupulous participants.
Risks and opportunities for producers
The transition to register-based accounting increases the importance of data consistency between:
– registration dossier;
– production documentation ( industrial regulations , series reports);
– entries in the registry.
Any discrepancy (for example, the absence of an indication of the intermediate synthesis site or a change in the packaging address) may lead to questions from the regulator and even be considered a violation, up to and including the recognition of the product as unregistered.
On the other hand, when implemented correctly, the registry model simplifies the introduction of changes to the dossier related to production modernization, since a separate supporting document will not be required for each case.
The Ministry of Industry and Trade’s initiative is aimed not simply at changing the format, but at creating a unified digital profile of the production chain for each drug, which will ultimately improve the traceability and reliability of drug supply.
