Insights
Chronicle of regulatory change
We track changes in pharmaceutical regulation and publish what matters once a month - without the news noise.
These materials are for information purposes only and do not constitute legal advice.
Key regulationsSeptember 2026
Regulatory12 September 2026The VED list commission in August: 9 of 19, a single-indication precedent and a signal on exclusionsOn 5 and 7 August the Ministry of Health commission reviewed 19 applications and backed nine - five foreign originator products and four Russian ones. We go through the minutes: the votes, the prices fixed on record, the first-ever inclusion by a single indication (trastuzumab deruxtecan) and an instruction to consider removing 11 INNs from the list.Public procurement12 September 2026Full-cycle production as the cross-cutting criterion: what Resolutions No. 969 and No. 999 lock inIn August the Government tied 'full-cycle' status to two different procedures in two separate acts: the national regime in public procurement (Resolution No. 969 - the 'second one out' mechanics from 1 December) and the special registration route for drug shortages (Resolution No. 999). We break down how localisation is now confirmed, what a 'confirmed batch' is and which deadlines apply to which INNs.Regulatory12 September 2026New drug import rules from 2027: what the Ministry of Health proposes and what applicants should watchThe Ministry of Health has put out for public consultation draft rules on the import of medicines that will replace Resolution No. 853 from 1 September 2027. Quantity justification is tied to the purpose of import, a separate route via Roszdravnadzor is introduced for medical device manufacturers, and named-patient import requirements are tightened. Consultation runs until 18 September.
August 2026
Pharma market15 August 2026Asian pharma in Russia: the local-partner route and the cost of early mistakesOn 14 August Vademecum published an interview with WIT Pharma managing partner Dmitry Klimchuk on Chinese and Indian companies entering the Russian market. We unpack the key points: the licensee model, three cases at different stages of maturity, the typical reasons for commission rejections and the 10 October deadline.Pharma market7 August 2026Tirzepatide: standalone registration of a Chinese API reshapes the segmentThe Russian Ministry of Health has for the first time granted a marketing authorisation for the tirzepatide API to a Chinese manufacturer. Dmitry Klimchuk, in a comment for Vademecum, explains why standalone API registration turns the segment competitive and what it says about Asian pharma's entry strategy for Russia and the EAEU.
July 2026
Regulatory26 July 2026The VED list commission: lessons from April and 22 candidates for AugustIn April the Ministry of Health commission backed only 2 of 8 applications, while 22 medicines are already tabled for the August session. We look at what the decision statistics show and what sets successful dossiers apart.Public procurement21 July 2026'Second one out' postponed to 1 December 2026: what changes for suppliersThe Government has pushed back the launch of the 'second one out' mechanism for strategically important medicines from 1 July to 1 December 2026. A pause is not a cancellation: the SIM list is expanding, and landing in its first section changes a product's fate at tender.EAEU14 July 2026Marketing authorisations after 31 December 2025: reading the EAEU transition periodNational marketing authorisations are formally a thing of the past, but in practice a complex matrix of transitional statuses applies. The Ministry of Health clarified the rules in Letter No. 25-6/894 - we break down which deadlines apply to which categories of products.
Legislation
Key industry documents
The main regulations governing the circulation of medicines, pricing and public procurement in Russia and the EAEU. Links lead to official sources.
Federal Law No. 61-FZ 'On the Circulation of Medicines'of 12 Apr 2010, current versionFederal Law No. 323-FZ 'On the Fundamentals of Protecting Citizens' Health in the RF'of 21 Nov 2011, current versionFederal Law No. 44-FZ 'On the Contract System in Procurement'of 5 Apr 2013, public procurement of medicinesVital & Essential Drugs List - Government Decree No. 3867-rof 18 Dec 2025, in force from 24 Feb 2026Government Decree No. 462 - price regulation for VED drugsof 8 Apr 2025EAEU law: EEC Council Decision No. 78 'Rules for registration and assessment of medicines'of 3 Nov 2016, current version