The Ministry of Health of the Russian Federation published Information Letter No. 25-6/894 dated January 29, 2026, explaining the procedure for handling medicinal products after the end of the EAEU transition period. The regulator has introduced a special “Expired” (ИСТ) status in the State Register (GRLS) and confirmed the conditions for continuing to operate in the market until 2027.
Legal operation until 2027 conditions:
The Ministry of Health has confirmed the validity of Russian Government Resolution No. 353 (as amended by Resolution No. 2202 of December 29, 2025), which allows for the extension of the life cycle of drugs that have not undergone the procedure of bringing them into line with Union standards.
National registration certificates (РУ) for such drugs are automatically extended until January 1, 2027, subject to one key condition: the drug must have been in civilian circulation in the Russian Federation for at least the last three calendar years as of December 1, 2025.
The above provision allows for the circulation of medicinal products including the manufacture of medicinal products, their import into the Russian Federation, and their circulation until the expiry date of medicinal products, if they were manufactured before the expiry date of registration certificates before January 1, 2027.
The Ministry of Health has confirmed the validity of Russian Government Resolution No. 353 (as amended by Resolution No. 2202 of December 29, 2025), which allows for the extension of the life cycle of drugs that have not undergone the procedure of bringing them into line with Union standards.
National registration certificates (РУ) for such drugs are automatically extended until January 1, 2027, subject to one key condition: the drug must have been in civilian circulation in the Russian Federation for at least the last three calendar years as of December 1, 2025.
The above provision allows for the circulation of medicinal products including the manufacture of medicinal products, their import into the Russian Federation, and their circulation until the expiry date of medicinal products, if they were manufactured before the expiry date of registration certificates before January 1, 2027.
The Ministry emphasizes that paper registration certificates will not be reissued. The only legally valid confirmation of the validity period of a registration certificate is the current entry in the electronic register.