A working meeting with representatives of the European Business Association was held at the State Expert Center of the Ministry of Health of Ukraine, dedicated to upcoming changes in the regulation of the pharmaceutical market.
The discussion concerned preparations for the implementation of the Law of Ukraine "On Medicinal Products", which will enter into force on 1 January 2027.
One of the issues of greatest concern to the market is the proof of bioequivalence of medicinal products. During the meeting, the importance of forming a coordinated approach to bioequivalence studies that would meet European standards and ensure uniform rules for the market was emphasized.
Also in focus of the discussion was the creation of the Ukrainian Pharmaceutical Agency and its possible models. Participants noted the importance of transparency of future changes and maintaining clarity of regulatory procedures regardless of the chosen model.
Among other issues discussed were:
- practical application of new legislative requirements;
- impact of institutional changes on registration procedures;
- approaches to labeling of medicinal products;
- organization and timelines for review of materials;
- approaches to conducting legal expert evaluation.
It was separately emphasised that all registration procedures started in 2026 will be completed, and the review of materials continues as usual.
The key message of the meeting – it is important to ensure clear and predictable rules for the market, taking into account both legislative requirements and the practice of their application.
Open dialogue with the market remains a key tool for preparing for changes and will continue.
