RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of August 12, 2015 No. 597

About introduction of amendments to the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376

The Cabinet of Ministers of Ukraine decides:

1. Bring in the 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)" (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, 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 till March 31, 2019.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of August 12, 2015 No. 597

Changes which are made to the resolution of the Cabinet of Ministers of Ukraine of May 26, 2005 No. 376

1. According to the procedure of state registration (re-registration) of medicines, approved by the specified resolution:

Item 2 after the paragraph of third to add 1) with the new paragraph of the following content:

"State registration of the medicine which is subject to purchase by results of the procurement procedure which is carried out by the specialized organization conducting procurement in pursuance of the purchase agreement between the Ministry of Health and the relevant specialized organization conducting procurement performs the Ministry of Health based on the statement and the conclusion of the Center constituted by results of carrying out in the procedure for examination of registration materials determined by the Ministry of Health concerning their authenticity.".

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