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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of August 16, 2022 No. 915

About modification of the Procedure for state registration (re-registration) for medicines

The Cabinet of Ministers of Ukraine decides:

1. Bring in the Procedure for state registration (re-registration) for medicines approved by the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376 (The Official Bulletin of Ukraine, 2005, No. 22, Art. 1196; 2012, No. 60, Art. 2421; 2015, No. 24, the Art. 671), changes which are applied.

2. This resolution becomes effective from the date of its publication and is effective within three months from the date of the termination or cancellation of warlike situation.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of August 16, 2022 No. 915

Changes which are made to the Procedure for state registration (re-registration) for medicines

Add Item 8 with the new paragraph of the following content:

"The Ministry of Health makes in accordance with the established procedure decisions on temporary or total ban of use of medicine by cancellation of the registration certificate irrevocably of collection for state registration of such means in case of factual determination that the applicant (the owner of the registration certificate) of medicine or the representative authorized by it directly or indirectly are connected with subjects of managing, including their representatives, separate divisions (branches, representations), licensees, applicants, producers and suppliers, performing straight line or the mediated activities for production of medicines in the territory of the state aggressor of (Russian Federation) or Republic of Belarus, or after February 23, 2022 made transactions concerning participation at least in one of production phases of medicine or AFI by the company, located in the territory of the state aggressor of (Russian Federation) or Republic of Belarus, providing to such company in use the pharmaceutical tangible or intangible assets or the related patents, permissions, licenses, registration certificates, the rights and other documents necessary for production of pharmaceutical products, including medicines, and also productions of AFI, performed transfer them in employment (lease) or alienated them directly or indirectly in property of residents of the state aggressor of (Russian Federation) or Republic of Belarus for production of pharmaceutical products. In case of establishment of the specified fact the decision on temporary or total ban of use of medicine by cancellation of the registration certificate irrevocably of collection is accepted to state registration in the procedure established by the Ministry of Health. At the same time the decision on total ban of medicine is made not earlier than in three months after decision making about temporary suspension of action of the registration certificate on such medicine in coordination with the Cabinet of Ministers of Ukraine in case the applicant (the owner of the registration certificate) continues the activities provided by the first offer of this paragraph.".

Add Item 9 after the paragraph of third with the new paragraph of the following content:

"The Ministry of Health refuses state registration of medicine in case by results of examination and/or consideration of registration materials which are enclosed to the application for state registration of medicine it is revealed that at least one of production phases of medicine is performed by the companies which production capacities are located in the territory of the state aggressor of (Russian Federation) or Republic of Belarus.".

With respect thereto the fourth and fifth to consider paragraphs respectively paragraphs the fifth and sixth.

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