Ukraine

The Cabinet of Ministers returns mandatory state control over the quality of medicines

Starting from 1 January 2025, Ukraine will reintroduce state quality control of medicinal products, as well as verification of compliance with licensing requirements in the areas of production, trade and import of medicines.

According to Taras Melnychuk, Permanent Representative of the Cabinet of Ministers in the Verkhovna Rada, the relevant amendments to the Cabinet of Ministers Resolution No. 303 of 13 March 2022 ‘On Termination of State Supervision (Control) and State Market Supervision under Martial Law’ were adopted by the Government.

It is envisaged to resume from 1 January 2025 the implementation of planned measures of state supervision (control) over compliance by business entities with the requirements of the legislation on the quality of medicines, the Licensing Conditions for the Conduct of Economic Activities for the Cultivation of Plants Included in Table I of the List of Narcotic Drugs, Psychotropic Substances and Precursors Approved by the Cabinet of Ministers, development, production, manufacture, storage, transportation, acquisition, sale (release), importation into the territory of Ukraine, exportation from the territory of Ukraine, use, and disposal of medicines.

In addition, state supervision over compliance with licensing requirements for the production, wholesale and retail trade, as well as import of medicines (except for active pharmaceutical ingredients) will be restored, in accordance with the Cabinet of Ministers’ Resolution No. 929 of 30 November 2016.

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