Unofficial transfer (c) Soyuzpravoinform LLC
of January 21, 2026 No. 56
About modification of the Procedure for state registration (re-registration) for medicines
The Cabinet of Ministers of Ukraine decides:
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; 2024, No. 46, Art. 2848; 2025, No. 13, the Art. 987), the enclosed changes.
Prime Minister of Ukraine
Yu.Sviridenko
Approved by the Resolution of the Cabinet of Ministers of Ukraine of January 21, 2026 No. 56
1. Add Item 32 with the paragraph of the following content:
"Marking of packaging of medicine of the Ukrainian production by the It Is Made in Ukraine trademark according to appendix to the resolution of the Cabinet of Ministers of Ukraine of February 23, 2024 No. 197 (The Official Bulletin of Ukraine, 2024, No. 24, the Art. 1537) is performed by domestic manufacturers on a voluntary basis and does not require modification of registration materials of medicine. The original - prototype of graphic design of packaging of medicine using such trademark is provided by the applicant in Gosleksluzhbu for the purpose of implementation of the state control of the medicines which are in circulation.".
2. Add Item 37-1 with the paragraph of the following content:
"Marking of packaging of medicine of the Ukrainian production by the It Is Made in Ukraine trademark is not violation of requirements for marking of medicines and respectively is not the basis for adoption by the Ministry of Health of the decision on temporary suspension of the registration certificate on medicine.".
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