RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of November 14, 2011 No. 1165

About modification of the Procedure for state registration (re-registration) for medicines

Due to the accession to the international system of cooperation of pharmaceutical inspections and for the purpose of ensuring fulfillment of requirements of article 11 of the Law of Ukraine "About medicines" the Cabinet of Ministers of Ukraine decides:

1. 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 in 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, the Art. 982), changes which are applied.

2. To the Ministry of Health:

take measures concerning reduction till July 1, 2013 by owners of registration certificates on medicines which registered (re-registered) medicines to the introduction in operation of this resolution, registration materials in compliance with this resolution;

in three-months time to bring own regulatory legal acts into accord with this resolution.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of November 14, 2011 No. 1165

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

1. In Item 2 of the word "The MZ state pharmacological center (дальшеЦентр)" shall be replaced with words "The state MZ expert center (further - the Center), according to the procedure, certain MZ".

2. In Item 3:

The paragraph the tenth to state 1) in such edition:

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