RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of August 8, 2016 No. 558

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; 2008, No. 31, Art. 982; 2011, No. 88, Art. 3208; 2012, No. 60, Art. 2421; 2015, No. 24, Art. 671, No. 67, Art. 2210; 2016, No. 35, the Art. 1359), changes which are applied.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of August 8, 2016 No. 558

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

1. In Item 2:

The paragraph third to state 1) in the following edition:

"State registration of the medicine registered by competent authority of the United States of America, Switzerland, Japan, Australia, Canada according to the centralized procedure by competent authority of the European Union for application in the territory of such countries or member states of the European Union, is 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.".

2) to add Item with the paragraph of the following content:

"Information on the submitted applications for state registration, condition of consideration of documents and the decisions made by its results gratuitously is published on the website of the Center.".

2. The tenth and eleventh Item 3 to exclude paragraphs.

3. In Item 3-4:

Paragraph one to state 1) in the following edition:

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