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RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of May 20, 2015 No. 75

About approval of the Instruction about procedure for the organization of system of pharmakonadzor and procedure for control of producers of medicines regarding compliance of the organization and functioning of system of pharmakonadzor to requirements of Proper practice of pharmakonadzor

Based on part three of article 11 of the Law of the Republic of Belarus of July 20, 2006 "About medicines", the paragraph of third subitem 8.17 of Item 8 and 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. Approve the enclosed Instruction about procedure for the organization of system of pharmakonadzor and procedure for control of producers of medicines regarding compliance of the organization and functioning of system of pharmakonadzor to requirements of Proper practice of pharmakonadzor.

2. This resolution becomes effective after its official publication.

Minister

V.I.Zharko

Approved by the Resolution of the Ministry of Health of the Republic of Belarus of May 20, 2015 No. 75

The instruction about procedure for the organization of system of pharmakonadzor and procedure for control of producers of medicines regarding compliance of the organization and functioning of system of pharmakonadzor to requirements of Proper practice of pharmakonadzor

1. This Instruction determines procedure for the organization of system of pharmakonadzor and procedure for control of producers of medicines regarding compliance of the organization and functioning of system of pharmakonadzor to requirements of Proper practice of pharmakonadzor.

2. In this Instruction terms and their determinations in the values established by the Law of the Republic of Belarus of July 20, 2006 "About medicines" are used (The national register of legal acts of the Republic of Belarus, 2006, No. 122, 2/1258), and also the following terms and their determinations:

the file (master file) of system of pharmakonadzor - the detailed description of the system of pharmakonadzor applied by producer of medicines in relation to data on one or several medicines registered in the Republic of Belarus;

measures for risk minimization - complex of the actions directed to prevention or reduction of probability of emergence of the undesirable reaction connected with medicine impact or to reduction of severity of undesirable reaction in case of its development in case of medicine use;

signal - information arriving from one or several sources which assumes availability of new potential cause and effect relationship or new aspect of the known interrelation between impact of medicine and undesirable reaction or set of the interconnected undesirable reactions, estimated as sufficient for further actions for its confirmation;

risk management system - complex of the actions for pharmakonadzor directed to identification, the characteristic, prevention or risk minimization, connected using medicine including efficiency evaluation of these actions;

ratio of advantage and risk - assessment of positive therapeutic effects of medicine in relation to the risks connected with its use including any risk connected with quality, safety or efficiency of medicine in relation to health of the person.

3. The system of pharmakonadzor will be organized:

at the republican level - the Ministry of Health (further - system of pharmakonadzor of the Republic of Belarus) based on the republican unitary enterprise "The Center of Examinations and Testing in Health Care" (further - the Company);

at the level of producer of medicines - producer of this medicine (further - system of pharmakonadzor of the producer of medicines).

4. The main objectives of system of pharmakonadzor of the Republic of Belarus are:

implementation of the actions aimed at safety of the medicines registered in the Republic of Belarus;

early detection of all changes in the ratio advantage and risk of medicines;

ensuring use of medicines on condition of excess of advantage over risk;

implementation of measures for providing the population of the Republic of Belarus with safe, effective and high-quality medicines.

5. The system of pharmakonadzor of the Republic of Belarus includes the following main events:

5.1. information assessment about:

the risks concerning health of the person connected using medicine and also results of impact of medicine to which the person in the course of accomplishment of activities of professional nature underwent, or not connected with professional activity;

the revealed undesirable reactions from health, pharmaceutical workers;

changes in assessment of profile of the safety of medicine placed by authorized bodies of foreign states;

5.2. determination of measures for minimization and prevention of risk, and also measures for restriction of distribution and (or) prescription of medicine;

5.3. receipt of the exact and confirmed data on undesirable reactions for providing their scientific assessment;

5.4. timely assessment of the data obtained when implementing pharmakonadzor with determination in need of measures for safety of use of medicine in case of excess of advantage over risk;

5.5. taking measures to ensuring accomplishment by producers of medicines of tasks and obligations to pharmakonadzor;

5.6. the organization of effective cooperation with bodies (organizations) of foreign states authorized on implementation of pharmakonadzor for the purpose of ensuring interaction in the direction of control of safety of medicines.

6. Producers of medicines provide the organization and functioning of system of pharmakonadzor according to requirements of Proper practice of pharmakonadzor.

7. The main objectives of system of pharmakonadzor of the producer of medicines are:

implementation of the actions aimed at safety of the medicines made by it, including early detection of all changes in assessment of ratio of advantage and risk of medicines;

accomplishment of proper assessment of all information on the risks connected using the medicines made by it including identification, studying and assessment of signals;

prevention of undesirable effects of use of medicines;

ensuring use of medicines in case of excess of advantage over risk;

implementation of measures for providing the population of the Republic of Belarus with safe, effective and high-quality medicines;

accomplishment of other requirements of the legislation for pharmakonadzor.

8. For ensuring functioning of system of pharmakonadzor with producer of medicines the authorized person on pharmakonadzor is designated.

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