Strengthening Control over Licensing Conditions in the Circulation of Medicinal Products

October 6, 2025 The Draft Law of Ukraine No. 14100 “On Amendments to Certain Laws of Ukraine Regarding Data Verification in the Field of Health Care” was registered in the Verkhovna Rada.

The Draft Law is aimed at improving the operation of the Electronic Health Care System (EHCS) and increasing the reliability of patient and medical professional data.

Key innovation is the proposal to supplement the Law of Ukraine “Fundamentals of Ukrainian Legislation on Health Care” with a provision under which the National Health Service of Ukraine (NHSU) will be able, upon request, to transfer to the State Service of Ukraine on Medicines and Drugs Control information about pharmaceutical workers registered in the Electronic Health Care System.

This is proposed to be done with the aim of increasing the level of control over the licensees’ compliance with Licensing Conditions for carrying out business activities in the manufacture, wholesale and retail trade, and import of medicinal products (excluding active pharmaceutical ingredients).

The transferred information about pharmaceutical workers will include:

• Personal and Identification Data: Surname, given name, patronymic; tax number or passport data (in specified cases);
• Professional Data and Qualifications: Information on educational and qualification level, specialization, advanced training, and job title;
• Licensee Data and Justification for the Request: Name of the licensee (legal entity or individual entrepreneur); reference to the legal grounds and justification for the necessity of obtaining the information; list (composition) of information about pharmaceutical workers being requested.

In addition, the Draft Law provides for:

• Expansion of EHCS information exchange with other state registers, particularly MIA systems and the demographic register, for verification of personal data, including the tax ID number;
• Expansion of the use of data from the State Register of Insured Persons to verify the reliability of information in the EHCS and documents that form the basis for the payment for medical services.

The adoption of the Draft Law will strengthen the control system in the healthcare sector, reduce the risks of abuse when paying for medical services, and ensure the transparent use of budget funds within the medical guarantee program.

We will closely monitor further developments in this area and will report on this in future Legal News.