By Resolution No. 999 of August 10, 2026, the Government of Russia amended the procedure for the circulation of medicinal products in conditions of shortages or the threat of shortages, approved by Resolution No. 593 of April 5, 2022.
Main innovations
– Clarification of the criterion for the absence of analogs. To apply the simplified regime, not only the absence of therapeutic substitutes is now required, but also confirmation that production under the given INN (including the synthesis of the active substance molecule) is not carried out within the Russian Federation at any stage.
– Additional dossier requirements. Subclauses “g1” and “g2” have been introduced, requiring the provision of information on the localization of production.
Differentiated requirements
– For biological products, confirmation of all stages of production in the Russian Federation is required if there has been no previous production under this INN in the country.
– For other drugs, it is sufficient to confirm the localization of key stages: production of the finished dosage form, primary and secondary packaging, and quality control at release.
The significance of the changes
New rules:
– tighten the verification of the degree of localization when using a simplified registration mechanism;
– introduce a differentiated approach for biological and other medicinal products;
– stimulate the creation of a full cycle of production of pharmaceutical substances in Russia, including the synthesis of the active substance.
Manufacturers planning to register under the anti-sanctions regime now require more detailed documentary justification for the localization of technological stages.
