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 regulations

August 2026

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 suppliersGovernment Resolution No. 835 of 3 July 2026 has pushed back the launch of the 'second one out' mechanism for strategically important medicines by five months. 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 version Federal Law No. 323-FZ 'On the Fundamentals of Protecting Citizens' Health in the RF'of 21 Nov 2011, current version Federal Law No. 44-FZ 'On the Contract System in Procurement'of 5 Apr 2013, public procurement of medicines Vital & Essential Drugs List - Government Decree No. 3867-rof 18 Dec 2025, in force from 24 Feb 2026 Government Decree No. 462 - price regulation for VED drugsof 8 Apr 2025 EAEU law: EEC Council Decision No. 78 'Rules for registration and assessment of medicines'of 3 Nov 2016, current version