Russia

Russia regulates pharmaceutical products through a dual structure: the Ministry of Health of the Russian Federation (Minzdrav) issues marketing authorisations (registratsionnoye udostovereniye, RU) for medicines via its Department of State Regulation of Medicines Circulation, while the Federal Service for Surveillance in Healthcare (Roszdravnadzor) handles GMP/GDP inspection, post-market surveillance, pharmacovigilance, medical devices and licensing of pharmaceutical activity. The regulatory framework is set by Federal Law No. 61-FZ 'On Circulation of Medicines' (2010, as amended) and supporting decrees and orders. Since 2021, Russia operates within the Eurasian Economic Union (EAEU) common pharmaceutical market alongside Armenia, Belarus, Kazakhstan and Kyrgyzstan. New marketing authorisation applications are filed under EAEU rules (Decision No. 78 of the EAEU Council, 2016), with two routes: Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP). Pre-2021 national RUs were required to be brought into EAEU compliance by 31 December 2025; transition arrangements remain in flux. Russia is not a PIC/S or ICH member, but the EAEU GMP rules are largely aligned with EU and PIC/S GMP. Public-sector access runs through the Compulsory Medical Insurance (OMS) system, regional drug provision programmes (LLO), the federal '14 High-Cost Nosologies' programme, and the Essential and Vital Medicines List (Zhiznenno Neobkhodimye i Vazhneyshie Lekarstvennye Preparaty — ZhNVLP). Prices for ZhNVLP-listed medicines are state-regulated and registered with Minzdrav. Western sanctions imposed since 2022 have not formally targeted medicines, but have created significant logistics, payment and supply-chain challenges; parallel imports of selected medicines and substances were legalised by Decree No. 506 (2022) for products whose manufacturers exited the Russian market.