From January 1, 2025, the Cabinet of Ministers of Ukraine plans to restore state control over the quality of medicinal products, as well as compliance with licensing conditions in the pharmaceutical industry. This was announced by Taras Melnychuk, the permanent representative of the government in the Verkhovna Rada.
Why is this important?
The restoration of control became possible after amendments were made to Cabinet Resolution No. 303 dated March 13, 2022, which temporarily suspended state supervision due to the complications of martial law. From 2025, Ukraine will return to stricter monitoring of the quality of medicines, which will include control over the production, trade and import of medicines.
Main changes in the supervision system
According to the innovations, the state will monitor:
- Quality of medicinal products – The Government is restoring control over compliance with quality standards of medicinal products, the quality of which is critically important for the protection of public health.
- Licensing Conditions – Manufacturing, wholesale and retail trade, and importation of drugs will again be under control, except for active pharmaceutical ingredients. This is stipulated by Cabinet of Ministers Resolution No. 929 dated November 30, 2016.
- Control over the circulation of narcotic drugs and precursors - The Government will also introduce supervision over all stages of the circulation of narcotic and psychotropic substances, from the cultivation of plants to the destruction of the corresponding drugs. This control is particularly important in ensuring the transparency and legality of the use of such substances.
What does this mean for the pharmaceutical market?
Restoration of supervision means strengthening control at all levels - from manufacturers to final sellers of medicines. This will reduce the risk of low-quality drugs appearing on the market, raise the standards of storage and sale, and also ensure more reliable compliance with the legislation in the field of psychotropic substances.
