of June 8, 2011 No. 03-3-11/841/387
To chiefs of managements of health care of regional executive committees
To the chairman of Healthcare Committee of Mingorispolkom
To heads of the organizations of health care (according to the list)
To the legal entities having the license for pharmaceutical activities (according to the list)
Explanations concerning carrying out clinical testing of medicines, products of medical appointment and medical equipment
Due to the arriving requests concerning carrying out clinical testing of medicines, products of medical appointment and medical equipment the Ministry of Health of the Republic of Belarus (further - the Ministry) explains the following.
In pursuance of Item 11 of the resolution of Board of the Ministry of March 25, 2011 the No. 4.1 Ministry suggests to provide the organization and high-quality accomplishment of clinical testing according to the procedure established for medicines by the resolution of the Ministry of May 7, 2009 No. 50 "About some questions of carrying out clinical testing of medicines" and the resolution of the Ministry of December 18, 2008 to No. 216 "About some questions of carrying out clinical testing of products of medical appointment and medical equipment" - for products of medical appointment and medical equipment.
At the same time the Ministry pays special attention on accomplishment of the following requirements under the organization and planning of clinical testing:
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