New era of medicine law in Ukraine
Despite the ongoing war with Russia, Ukraine is working harder than ever to align its legislation with that of the EU, in a bid to accelerate EU membership. In a long-awaited move, on 28 July 2022 Ukraine finally adopted the new Law on Medicines (the “Law”), with a view to harmonising Ukrainian pharmaceutical regulations and governance with EU approaches. The Law is an overhaul of the Ukrainian pharmaceutical legislation, with substantial changes across most if not all areas of regulation (R&D, manufacturing, authorisation, circulation, licensing, state surveillance, pharmacovigilance, promotion, etc.). The Law will enter into force gradually, with sufficient time for all market players to become fully prepared.
In this series of articles, we will provide a detailed analysis of what changes the Law brings to the key topics, including:
- governance
- pharmaceutical R&D
- authorisation process
- expanded access
- licensing
- anti-counterfeiting
- state surveillance
- pharmacovigilance
- advertising and promotion
