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RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of May 26, 2005 No. 376

About approval of the Procedure for state registration (re-registration) of medicines and the amount of collection for their state registration (re-registration)

(as amended on 15-04-2020)

According to articles 9 and 9-1 of the Law of Ukraine "About medicines" the Cabinet of Ministers of Ukraine decides:

1. Approve applied:

Procedure for state registration (re-registration) for medicines;

the amount of collection for state registration (re-registration) of medicines.

2. Recognize invalid:

the resolution of the Cabinet of Ministers of Ukraine of September 13, 2000 No. 1422 "About approval of the Procedure for state registration (re-registration) of medicine and the amount of collection for state registration (re-registration) of medicine" (The Official Bulletin of Ukraine, 2000, No. 37, the Art. 1587);

item 4 of changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of June 21, 2001 No. 678 (The Official Bulletin of Ukraine, 2001, No. 26, the Art. 1170);

Item of 3 changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of July 24, 2003 No. 1146 (The Official Bulletin of Ukraine, 2003, No. 31, the Art. 1605);

paragraphs the fourth - the sixth Item 1 of the resolution of the Cabinet of Ministers of Ukraine of October 28, 2004 No. 1419 "Some measures concerning quality assurance of medicines" (The Official Bulletin of Ukraine, 2004, No. 44, the Art. 2877).

Prime Minister of Ukraine

Yu. Tymoshenko

Approved by the Resolution of the Cabinet of Ministers of Ukraine of May 26, 2005, No. 376

Procedure for state registration (re-registration) for medicines

1. This Procedure establishes the mechanism of carrying out state registration (re-registration) of the medicines determined by article 2 of the Law of Ukraine "About medicines" (further - medicines including medical immunobiological supplies) which use in Ukraine is allowed only after such registration.

Medicines which are made in drugstores according to recipes of doctors (the main formulas) and by request of treatment-and-prophylactic institutions (official formulas) from allowed for use acting and excipients are not subject to state registration.

2. State registration of medicine is performed by the Ministry of Health based on the statement and results of the expertize of registration materials on such means which is carried out by the State MZ expert center (further - the Center) in the procedure determined by the Ministry of Health.

If medicine is registered by the European agency on medicines, state registration of original medicine is performed without conducting the specified examination based on the statement, registration materials, including the report on assessment of the registration file of the specified Agency, and the conclusion of the Center concerning compliance of the instruction for application and medicine methods of quality control to registration materials. Such compliance is performed in the procedure determined by the Ministry of Health.

State registration of the medicine registered by competent authority of the United States of America, the Swiss Confederation, Japan, Australia, Canada according to the centralized procedure by competent authority of the European Union is also applied in the territory of such countries or member states of the European Union, performed based on the statement and the conclusion of the Center constituted by results of carrying out in the procedure for consideration of the materials enclosed to the application established by the Ministry of Health.

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