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LETTER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of April 26, 2013 No. 03-3-11/823/459

"About carrying out clinical testing"

(as of September, 2013)

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 prescription 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 coordination with 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);

1.2. by means of forming of groups of researchers and registration with them the civil relations;

1.3. within the employment contracts signed between the employer and participants of group of researchers;

2. in the organizations of health care of system of the Ministry of Health:

2.1. by means of forming of groups of researchers and registration with them the civil relations;

2.2. within the employment contracts signed between the employer and participants of group of researchers.

Concerning creation of VNK

Creation and activities of VNK is performed according to the Regulations on procedure for creation and on conditions of activities of VNK approved by the Presidential decree of the Republic of Belarus of June 26, 2009 No. 349 "About measures for enhancement of procedure for creation and conditions of activities of temporary research teams".

Concerning registration of the civil relations

According to the Presidential decree of the Republic of Belarus of June 6, 2005 No. 314 "About some measures for protection of the rights of the citizens performing work on civil and employment contracts" (further - the Decree No. 314) citizens can perform work on civil agreements taking into account the conditions established by this Decree.

After the conclusion clinical agreement base on carrying out clinical testing with the customer (further - the basic agreement) for the organization of work on carrying out clinical testing the head of clinical base the order creates according to the legislation of the Republic of Belarus the working groups of number of persons employed of clinical base and the involved employees (from their consent) with determination of the head of working group (the chief researcher). In such order also the regulations on operating procedure of this working group, including with determination of specific obligations of members of this group according to adopted agenda of clinical testing and the basic agreement shall be approved.

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