RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of May 7, 2009 No. 50

About some questions of carrying out clinical testing of medicines

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, "About medicines" in edition of the Law of the Republic of Belarus of August 5, 2008 the Ministry of Health of the Republic of Belarus DECIDES: parts three of article 15 of the Law of the Republic of Belarus of July 20, 2006

1. Approve enclosed:

1.1. technical code of common practice "Proper clinical practice" *;

1.2. The list of the documents submitted for purpose of clinical testing of medicines, and requirements to these documents.

______________________________

* It is not brought.

2. This resolution becomes effective since August 1, 2009.

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of May 7, 2009, No. 50

The list of the documents submitted for purpose of clinical testing of medicines, and requirements to these documents

1. For medicines of foreign production:

statement;

the draft of the program (protocol) of clinical testing of medicine with all available amendments to it (in case of their availability) on paper and electronic carriers;

the draft of the brochure of the researcher or the document replacing it on paper and electronic carriers;

the expert evaluation of documents on clinical testing executed by the independent expert, the specialist in profile of the studied pathology or scope of medicine (in the presence);

data on producer of medicine;

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