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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of July 16, 2025 No. 901

Some questions of maintaining and functioning of the State registers in the field of medicines

According to Article part ten 9, of part three of article 9-3 of the Law of Ukraine of April 4, 1996 No. 123/96-BP "About medicines", Items 18, 2, parts six of article 73 of the Law of Ukraine of July 28, 2022 No. 2469-І X "About medicines" the Cabinet of Ministers of Ukraine decides 19 parts one of Article:

1. Approve enclosed:

Procedure for maintaining the State register of medicines;

Procedure for maintaining the State register of the medicines in parallel imported on the territory of Ukraine;

Procedure for maintaining the State register introduced into drug circulation, imported on the territory of Ukraine.

2. Determine that:

1) by day of enforcement of the Law of Ukraine of July 28, 2022 No. 2469-IX "About medicines" (further - the Law) the Procedure for maintaining the State register introduced into circulation of medicines, imported on the territory of Ukraine, approved by this resolution, extends to medicines which are in parallel imported on the territory of Ukraine by licensed parallel importers according to part one of article 78 of the Law. To the medicines determined by Items 1 and 2 of part one of article 73 of the Law, the Procedure for maintaining the State register introduced into drug circulation, imported on the territory of Ukraine, approved by this resolution, is applied from the date of enforcement of the Law;

2) the State register of medicines which are in parallel imported on the territory of Ukraine, and the State register introduced into drug circulation, imported on the territory of Ukraine begin to function after their input in operation by the Ministry of Health;

3) by day of formation of the central executive body with the special status realizing state policy in the field of creation, the admission on the market, the quality control, safety and efficiency of medicines determined by the Law, the powers of state control body determined by Procedure for maintaining the State register of medicines which are in parallel imported on the territory of Ukraine and Procedure for maintaining the State register introduced into drug circulation, imported on the territory of Ukraine, approved by this resolution rely on public service on medicines and control of drugs;

4) by day of introduction of the State register of medicines which are in parallel imported on the territory of Ukraine, and the State register introduced into drug circulation, imported on the territory of Ukraine, in operation:

information on medicines which are in parallel imported on the territory of Ukraine, including data on permissions to parallel import of medicines and on issuance of the medicines imported on the territory of Ukraine for the purposes of parallel import (further - information) is kept electronically and posted on the official website of Public service on medicines and control of drugs in the subsection "State Registers" in form according to appendix;

for inclusion in information of data on introduction into circulation of the medicines imported on the territory of Ukraine for the purposes of parallel import, the subjects of managing who got permission to parallel import of medicines submit to Public service on medicines and control of drugs the information message in any form with indication of information determined by Item 13 of the Procedure for maintaining the State register introduced into circulation of medicines, imported on the territory of Ukraine, approved by this resolution. Information specified in the information message is introduced by Public service on medicines and control of drugs in information within three working days from the date of their representation;

for confirmation of decision making about issue of permission to parallel import of the medicine imported on the territory of Ukraine for the purposes of parallel import by Public service on medicines and control of drugs to the subject of managing who got permission to parallel import of medicine issues the copy of the warrant of surrender of permission to parallel import of medicine certified in accordance with the established procedure.

3. Bring in the resolution of the Cabinet of Ministers of Ukraine of March 31, 2004 No. 411 "About approval of the Regulations on the State register of medicines" (The Official Bulletin of Ukraine, 2004, No. 13, Art. 897; 2008, No. 100, Art. 3313; 2010, No. 57, Art. 1961; 2015, No. 67, Art. 2211; 2016, No. 97, Art. 3153; 2019, No. 39, Art. 1373; 2020, No. 34, Art. 1137; 2022, No. 61, the Art. 3664) the enclosed changes.

4. Recognize invalid resolutions of the Cabinet of Ministers of Ukraine according to the enclosed list.

5. This resolution becomes effective from the date of its publication, except Item paragraph two 1, of the item 4 of this resolution, paragraph two of Item 15 of the Procedure for maintaining the State register introduced into drug circulation, imported on the territory of Ukraine, approved by this resolution which become effective along with enforcement of the Law.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of July 16, 2025, No. 901

Procedure for maintaining the State register of medicines

1. This Procedure determines the mechanism of forming and maintaining the State register of medicines (further - the Register), the procedure of entering of information into the Register on the medicines registered in accordance with the established procedure and about all changes in materials of the registration file of medicines, and also exception of register information on such medicines of the Register.

2. The terms used in this Procedure have the following value:

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