Government improves system of state registration of medicinal products

The Cabinet of Ministers of Ukraine has adopted amendments to the Procedure for State Registration of Medicinal Products. This decision is aimed at ensuring the swift availability of generic medicines on the pharmaceutical market and expanding opportunities for the procurement of new medicines, including those funded by the state budget.

The amendments provide for the application of a simplified state registration procedure for medicines intended for centralised procurement using state budget funds. This concerns medicines that:

• have already been verified by the competent authority of the United Kingdom;
• are included in the database of medicinal products that may be procured under the United States President’s Emergency Plan for AIDS Relief to assist in the fight against HIV/AIDS;
• have received Tentative Approval from the U.S. regulator;
• are included in the lists of medicinal products or vaccines prequalified by the World Health Organization.

This means that medicines whose efficacy and safety have been confirmed by international regulators will be able to reach Ukrainian pharmacies and hospitals more quickly.

The adopted amendments implement the provisions of the law passed in February 2025, which addresses the specific features of state registration for medicinal products that may be procured by an entity authorised to conduct procurement in the health sector, as well as the regulation of certain matters related to the sale of medicinal products.