As requested by Vademecum, VERBA LEGAL's Healthcare and Pharmaceuticals Practice has prepared an overview of the regulatory acts that took effect in June 2025 and relate to circulation of medicines and medical products. Additionally, the lawyers discussed other documents that are expected to take effect later on and industry-specific future regulations that are being drafted at present.
Contents of the Digest:
Circulation of Medicines:
Requirements to Clinical Study Agreements May Be Toughened;
Procedure for Delivery of Human Medicinal Products into the Stream of Commerce Updated;
Medicine Traceability Experiment Extended.
Circulation of Medical Products:
List of Non-VATable Medical Products Extended;
Russia's Healthcare Ministry Updated Requirements to Medical Products Documentation, Focusing on AI and Cybersecurity.
General Regulatory Update:
Russian Language Protection Law Published;
Prohibition on Informing Clients with the Use of Foreign Messengers;
Requirement to Document Personal Data Processing Consents Separately from Other Documents Becomes Statutory.
VERBA LEGAL's Healthcare Practice team, including Senior Partner Alexander Panov, Junior Associates Varvara Lavrukhina and Ivan Yapryntsev and Paralegal Rostislav Scheglov contributed to this Digest.