RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of March 18, 2015 No. 125

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; 2007, No. 22, Art. 865, No. 83, Art. 3078; 2008, No. 31, Art. 982; 2011, No. 88, Art. 3208; 2012, No. 60, the Art. 2421), changes which are applied.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of March 18, 2015 No. 125

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

1. State Item 2 in the following edition:

"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.

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