of April 26, 2013 No. 03-3-11/823/459
"About carrying out clinical testing"
To chiefs of managements of health care of regional executive committees
To the chairman of Healthcare Committee of Mingorispolkom
To heads of the organizations subordinated to the Ministry of Health of the Republic of Belarus (according to the list)
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 explains the following.
Concerning contractual legal relations when carrying out clinical testing
For the purpose of exception of violations of requirements of the civil legislation to perform the conclusion of the contract for carrying out clinical testing of medicines of national (foreign) production only after approval of all interested and approvals in the Ministry of Health of the program (protocol) of clinical testing, and also the draft agreement prepared in accordance with the established procedure including according to the approximate form of the agreement established by the order of the Ministry of Health of the Republic of Belarus of April 28, 2012 No. 467 "About some questions of carrying out clinical testing" in the Ministry of Health.
Exclude cases of the conclusion of contracts for carrying out clinical testing between researchers (physical persons) and customers of researches which contain additional terms of carrying out clinical testing, including additional payment of work of researchers.
Considering importance of question of carrying out clinical testing in the Republic of Belarus the Ministry of Health (in coordination with Council of Ministers of the Republic of Belarus) informs on possibility of use below the reflected approaches on the organization of carrying out clinical testing:
1. in the organizations of system of the Ministry of Health accredited in accordance with the established procedure as the scientific organizations:
1.1. by means of creation of temporary research teams (further - VNK);
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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