The Cabinet of Ministers of Ukraine has made important changes to the Licensing Conditions

The Cabinet of Ministers of Ukraine made a number of decisions introducing important changes to the Licensing Conditions for Economic Activities in the medicines’ manufacturing, wholesale and retail trade in medicines and import of medicines (except for active pharmaceutical ingredients), approved by Resolution of the Cabinet of Ministers of Ukraine No. 929 dated 30 November 2016 (hereinafter referred to as the Licensing Conditions).

The sale of medicines at petrol stations

On the premises of petrol stations, based on a license, only over-the-counter medicines may be sold by its employees, without the establishment of a pharmacy or its structural unit, provided that the storage conditions for medicines specified by the manufacturer are observed and the process of obtaining medicines is ensured and that incoming inspections are carried out by an authorized person of the business entity who has a higher education document of at least the initial level (short cycle) in the specialty “Pharmacy, industrial pharmacy,” without requirements for work experience, to which the business entity has assigned responsibilities for the functioning of the quality system for medicines within one region.

Petrol stations must have an area of at least 5 square meters to ensure proper storage conditions for medicines, as specified by the manufacturer, separate from other goods.

It is also permitted to sell over-the-counter medicines at petrol stations through vending machines, provided that the storage conditions for medicines specified by the manufacturer are observed and the process of obtaining medicines, conducting incoming inspections and loading medicines into vending machines is carried out by an authorized person of the business entity who has a higher education document not lower than the initial level (short cycle) in the specialty “Pharmacy, Industrial Pharmacy,” without any requirements for work experience, to whom the business entity has assigned responsibilities for the functioning of the medicines quality system within one region.

These reforms are aimed at improving the affordability and physical accessibility of over-the-counter medicines, especially in frontline regions, rural areas and areas with unstable electricity supplies.

Regulation of the range of products sold in pharmacies

A relevant government resolution has introduced mandatory sales in pharmacies located in state and municipal healthcare institutions of medicines with the three lowest prices specified in the National Price Catalogue. Thus, the range of such pharmacies will include medicines with the appropriate active ingredient and dosage that are financially beneficial to patients.

 Updating educational and qualification requirements

By a separate decision, the Government amended the Licensing Conditions in terms of requirements for pharmacy employees.

In particular, the requirements for education and professional training of specialists engaged in the retail sale of medicines have been updated: specialists with a broader range of relevant qualifications, as defined by legislation in the field of education and professional standards, can now be employed in pharmacies and pharmacy points.

In rural areas and territories of active combat operations, medicines may be dispensed in pharmacies (without manufacturing medicines) by specialists with a with a degree no lower than an associate’s degree in nursing and a certificate in pharmacy (retail trade in medicines).

This decision allows pharmacies to create their staff more effectively, especially in conditions of staff shortages, while ensuring that employees have the appropriate level of education and qualifications.

The requirement to have a certificate of eligibility to work in the field of “Pharmacy (retail sale of medicines)” for persons who have a degree in “Nursing” and are admitted to work in pharmacies in accordance with the Licensing Conditions shall apply from 01 July 2027.

Procedure for providing marketing services

The Government has also regulated the issue of marketing services in the field of medicines circulation. Such services may be provided by pharmacies to manufacturers and importers of medicines on a voluntary basis only. It is prohibited to initiate or demand marketing services as a mandatory condition for cooperation.

This decision should create a level playing field for pharmaceutical manufacturers, especially national ones and allow the transparent promotion of medicines in various price ranges, which in turn will help pharmacy visitors become more aware of the range and cost of medicines.

The decisions made by the Government are part of the plan of reduction and stabilization medicines’ prices, approved by the decision of the National Security and Defense Council of Ukraine dated 12 February 2025, “On Additional Measures to Ensure the Availability of Medicines for Ukrainians” and enacted by Decree of the President of Ukraine No. 82/2025 dated 12 February 2025.