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The document ceased to be valid since  July 21, 2015 according to Item 2 of the Order of the Minister of health and social development of the Republic of Kazakhstan of May 29, 2015 No. 421

I.O'S ORDER. MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 3, 2009 No. 647

About approval of Rules of carrying out monitoring of side effects of medicines in the medical and pharmaceutical organizations

(as amended of the Order of the Minister of Health of the Republic of Kazakhstan of 28.09.2012 No. 664)

According to article 85 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", PRIKAZYVAYU:

1. Approve the enclosed Rules of carrying out monitoring of side effects of medicines in the medical and pharmaceutical organizations.

2. To heads of local authorities of public administration by health care of areas, the cities of republican value and the capital (in coordination), and also the medical and pharmaceutical organizations irrespective of patterns of ownership:

1) to organize work on collection and provision of maps messages about side effects of medicines in authorized organization;

2) to appoint responsible persons in local authorities of public administration by health care of areas, the cities of republican value and the capital, the medical and pharmaceutical organizations irrespective of patterns of ownership for collection and provision of maps messages about side effects of medicines.

3. To committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan:

1) to organize collection, generalization of information on side effects of medicines for decision making on the side effects of medicines proved and confirmed with the international experience;

2) to determine authorized organization for carrying out collection, the analysis, processing (systematization) and implementation of scientific assessment of the arriving messages on side effects of medicines.

4. To the head of the authorized organization determined by Committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan:

1) to provide collection, the analysis, processing (systematization) and scientific assessment of the arriving messages on side effects of medicines and to monthly provide information in Committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan;

2) to publish quarterly information messages, state-of-the-art reviews, methodical recommendations in specialized editions and to post information on the website.

5. Medical and the pharmaceutical Ministries of Health of the Republic of Kazakhstan of activities in the procedure established by the legislation of the Republic of Kazakhstan to provide to committee of control state registration of this order in the Ministry of Justice of the Republic of Kazakhstan and its official publication in mass media.

6. Declare invalid the order of the Minister of Health of the Republic of Kazakhstan of February 14, 2005 No. 52 "About approval of the Instruction for carrying out monitoring of side effects of medicines" (registered in the Register of state registration of regulatory legal acts for No. 3489).

7. To impose control of execution of this order on the Vice-Minister of Health of the Republic of Kazakhstan Birtanov E. A.

8. This order becomes effective after ten calendar days after day of its first official publication.

Acting Minister

B. Sadykov

Approved by the Order of the deputy. Minister of Health of the Republic of Kazakhstan on November 3, 2009 No. 647

Rules of carrying out monitoring of side effects of medicines in the medical and pharmaceutical organizations

1. General provisions

1. These rules of carrying out monitoring of side effects of medicines in the medical and pharmaceutical organizations (further - Rules) determinations of forms and procedure for collection, the analysis of the revealed side effects, creations of the database about the revealed side effects of medicines and information managements, and also interactions of the bodies and organizations of health care responsible for its implementation are developed for the purpose of forming of single requirements to monitoring system of side effects of medicines.

2. In Rules the following concepts are used:

1) verification - the procedures performed for the purpose of confirmation of the fact that the data provided in the final report corresponded to original observations. Check covers medical records, messages on side effects, serious side effects and lack of efficiency, statistic analyses and tables;

2) the owner of the registration certificate - producer which bears responsibility for safety, efficiency and quality of the medicine allowed for medical application in the territory of the Republic of Kazakhstan;

3) additional preclinical and (or) clinical testing and (or) researches - researches which are conducted for the purpose of confirmation of clinical effects, pharmacological properties and (or) identification of all side effects of the researched medicine in case of its medical application, for the purpose of establishment of its safety and efficiency;

4) the map message about side effect or lack of efficiency of medicine (further - the map message) - information provided by the health and (or) pharmaceutical worker and (or) the owner of the registration certificate (his authorized representative), on the revealed cases of side effects, serious side effects or lack of efficiency in case of medical application of medicine and including the list of the questions allowing to carry out approximate determination of extent of cause and effect relationship of acceptance of medicine and its side effect, in form according to appendix 1 to these rules;

5) the map - the message on side effect or lack of efficiency of medicine in case of clinical trials (further - the map message of clinical trial) - information provided by the clinical researcher about the revealed cases of side effect, serious side effect and lack of efficiency of medicines in clinical trials on form according to appendix 2 to these rules;

6) monitoring of side effects - complex of the actions directed to detection, collection, assessment, the analysis and decision making on side effects of medicines;

7) health workers - the physical persons having professional medical education and performing medical activities;

8) pharmaceutical workers - the physical persons having pharmaceutical education and performing pharmaceutical activities;

9) lack of efficiency of medicine - lack of favorable medical effect of medicine on the current, duration of disease and quality of life of the patient;

10) side effect - any reaction, unforeseen and (or) harmful to human body, which arises when using medicine in recommended doses, in case of which there is cause and effect relationship with medicine;

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