RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of April 20, 2016 No. 312

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, Art. 2421; 2015, No. 24, the Art. 671, No. 67, the Art. 2210), changes which are applied.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of April 20, 2016 No. 312

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

1. In Item 3:

1) the last offer of paragraph one to exclude;

Paragraph two to state 2) in the following edition:

"For conducting examination of registration materials by the applicant move in the Center:";

3) to add Item after subitem 5 with new paragraphs of the following content:

"The procedure for conducting examination of the registration materials specified in subitems 1 - 5 these Items, requirements to them determines the Ministry of Health in coordination with the Ministry of Economic Development.

The deadline of conducting examination of registration materials on the medicine registered by competent authority of the United States of America, Switzerland, Japan, Australia, Canada or the European Union as medicine and allowed for use in the territories of these countries constitutes 20 working days.

In case of non-presentation during the specified term by the Center of conclusions and recommendations examination is considered carried out.".

With respect thereto the ninth - the twelfth to consider paragraphs respectively paragraphs the twelfth - the fifteenth;

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