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Ministry of Justice of Ukraine

December 8, 2015

No. 1520/27965

ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of October 1, 2015 No. 639

About modification of the Procedure for carrying out clinical testing of medicines and examination of materials of clinical testing

According to Articles 7, 8 Laws of Ukraine "About medicines", the Directive of the European Parliament and Council 2001/20/EU of April 04, 2001 "About approach of the laws, bylaws and administrative provisions of state members concerning introduction of proper clinical practice when carrying out clinical testing of medicines for the use by the person" (with changes), and also for the purpose of further enhancement and streamlining of carrying out clinical testing of medicines ORDER:

1. Approve Changes in the Procedure for carrying out clinical testing of medicines and examination of materials of clinical testing approved by the order of the Ministry of Health of Ukraine of September 23, 2009 No. 690, registered in the Ministry of Justice of Ukraine on October 29, 2009 on No. 1010/17026 (in edition of the order of the Ministry of Health of Ukraine of July 12, 2012 No. 523) which are applied.

2. To management of pharmaceutical activities and quality of pharmaceutical products (Lyaskovsky T. M.) in accordance with the established procedure to provide submission of this order on state registration in the Ministry of Justice of Ukraine.

3. To impose control over the implementation of this order on the deputy minister of Shafransky V. V.

4. This order becomes effective from the date of its official publication.

Minister of Health of Ukraine

A. Kvitashvili

Approved by the Order of the Ministry of Health of Ukraine of October 1, 2015 No. 639

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