The Cabinet of Ministers approved changes to the Procedure for State Registration of Medicinal Products
The Cabinet of Ministers of Ukraine approved amendments to the Procedure for State Registration of Medicinal Products. This decision is intended to ensure faster access to generic drugs on the Ukrainian pharmaceutical market and expand opportunities for the purchase of new drugs, in particular from the state budget.
The amendments provide for a simplified procedure for the state registration of medicinal products that are purchased centrally from the budget. It applies to drugs that have already been reviewed by the competent authorities of the United Kingdom, are included in the drug database of the US President’s Emergency Plan to Fight HIV/AIDS (PEPFAR), have preliminary approval (Tentative Approval) from the US regulator, or are included in the list of prequalified drugs and vaccines of the World Health Organization.
Thus, drugs whose effectiveness and safety have been confirmed by international regulators will be able to enter the Ukrainian market faster – to pharmacies and medical institutions.
The adopted changes implement the provisions of the law adopted in February 2025, which determines the features of the state registration of drugs that can be purchased by authorized healthcare institutions, and also regulates issues related to the sale of these drugs.
