of May 4, 2012 No. 44
About entering of amendments and changes into the resolution of the Ministry of Health of the Republic of Belarus of May 7, 2009 No. 50
Based on parts one and the second article 40 of the Law of the Republic of Belarus of June 18, 1993 "About health care" in edition of the Law of the Republic of Belarus of June 20, 2008, part three of article 15 of the Law of the Republic of Belarus of July 20, 2006 "About medicines", subitem 9.1 of Item 9 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360" the Ministry of Health of the Republic of Belarus DECIDES:
1. Bring in the list of the documents submitted for purpose of clinical testing of medicines, and requirements to these documents, No. 50 approved by the resolution of the Ministry of Health of the Republic of Belarus of May 7, 2009 "About some questions of carrying out clinical testing of medicines", the following amendments and changes:
in Item 1:
third to add the paragraph with the words "on paper and electronic carriers";
the fourth to add the paragraph with the words "on paper and electronic carriers";
the seventeenth to state the paragraph in the following edition:
"samples of the researched medicine (the series provided for carrying out clinical testing) in the quantity necessary for carrying out quality check in the territory of the Republic of Belarus and standard samples of medicine with appendix of the quality certificate (in case of its availability);";
the twenty first to add the paragraph with words "(if necessary)";
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