ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of May 29, 2015 No. 421

About approval of Rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products

According to Item 2 of 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 Rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products.

2. Recognize as the deputies who voided the order. The 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" (No. registered in the Register of state registration of regulatory legal acts 5910, No. published in the Collection of acts of the central executive and other central state bodies of the Republic of Kazakhstan 3, 2010) and Item 1 of the List of regulatory legal acts of the Ministry of Health of the Republic of Kazakhstan to which changes are made, No. 664 approved by the order of the Minister of Health of the Republic of Kazakhstan of September 28, 2012 "About modification of some regulatory legal acts of the Ministry of Health of the Republic of Kazakhstan (No. registered in the Register of state registration of regulatory legal acts 8081, No. 302 published in the Kazakhstanskaya Pravda newspaper on January 22, 2012 (27576)).

3. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of regulatory legal acts of the Republic of Kazakhstan of Ad_let;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan.

4. To impose control of execution of this order on the Vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

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

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of May 29, 2015, No. 421

Rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products

Chapter 1. General provisions

1. These rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products (further - Rules) determine procedure for carrying out pharmakonadzor and monitoring of safety, quality and efficiency of the medical products registered in the Republic of Kazakhstan.

2. The Pharmakonadzor is performed according to requirements of the Standard of proper practice of the pharmakonadzor approved by the order of the Minister of health and social development of the Republic of Kazakhstan of May 27, 2015 No. 392 "About approval proper pharmaceutical the practician" (it is registered in the Register of state registration of regulatory legal acts at No. 11506) (further - the Standard).

3. For the purposes of these rules the following terms and determinations are applied:

1) the absent information - lack of data on safety or about features of use of medicine for certain groups of patients which can be clinically significant;

2) potential risk - undesirable consequence of pharmacotherapy concerning which there are bases for suspicions on availability of interrelation with medicine however this interrelation properly was not confirmed;

3) validirovanny signal - signal for which in the course of accomplishment of validation and assessment of confirmatory data it is determined that the available documentation is sufficient for the assumption of availability of new potential cause and effect relationship or new aspect of the known interrelation between acceptance of the suspected medicine and development of adverse effect and, therefore, need of implementation of complex of further actions according to signal is determined;

4) 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 the undesirable phenomenon or set of the interconnected undesirable phenomena, estimated as sufficient for further actions for verification of signal;

5) state body in the sphere of drug circulation and medical products - the department of authorized body in the field of health care performing regulation in the sphere of drug circulation and medical products;

6) the state expert organization in the sphere of drug circulation and medical products - the republican state company on the right of economic maintaining performing production economic activity in the field of health care on safety, efficiency and qualities of medicines (further - the expert organization);

7) the risks connected using medicine - any risk connected with quality, safety or efficiency of medicine in relation to health of patients or the populations or any risk leading to undesirable impact on the environment;

8) serious deterioration in the state of health - life-threatening disease, permanent defeat of function of organism or irreversible damage of structure of body, the condition requiring medical or surgical intervention for the purpose of prevention of life-threatening disease, either permanent defeat of function of organism, or irreversible damage of structure of body, the condition requiring hospitalization or significant increase in term of stay in hospital of already hospitalized patient, functional violation from fruit, his death, congenital anomaly or patrimonial injury);

9) serious health hazard - any defect and (or) deterioration in characteristics, either violation of functioning of medical product, or insufficiency or incorrectness of accompanying information (documentation) on medical product, or the side effect which is not specified in the instruction for application which brought or can result in the inevitable risk of death, life-threatening disease, irreversible defeat of function of organism, irreversible damage of structure of body or condition requiring medical or surgical intervention for the purpose of prevention of irreversible defeat of function of organism or irreversible damage of structure of body and which require urgent medical actions;

10) authorized body in the field of health care (further - authorized body) - the central executive body performing management and cross-industry coordination in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, control of quality of medical services;

11) serious undesirable reaction - undesirable reaction which leads to death poses threat for life, requires hospitalization of the patient or its prolongation, results in the resistant or expressed disability or disability, to congenital anomalies or malformations, any inadvertent suspected transfer through medicine of the infectious agent requires medical intervention for prevention of development of the listed conditions, and also;

12) frivolous undesirable reaction - undesirable reaction which does not answer criteria of serious undesirable reaction;

13) undesirable event - any undesirable medical event, not predicted disease either damage or undesirable clinical signs (including the laboratory indicators other than regulation) at users or the third parties connected using medical product;

14) undesirable reaction - the inadvertent, adverse reaction of organism connected using the medicinal (researched) medicine and assuming availability of possible interrelation using this medicinal (researched) medicine;

15) the map message about undesirable reactions - information transferred according to established by form and content, about one or several suspected undesirable reactions to medicine;

16) unforeseen undesirable reaction - undesirable reaction, nature, severity or outcome of which does not correspond to information containing in the operating general characteristic of medicine, the instruction on medical application of medicine or in the brochure of the researcher for the unregistered medicine;

17) activities for risk minimization (measure 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;

18) the periodic updated report on safety - the report of the holder of the registration certificate of medicine for certain period of time during the post-registration period provided for ratio assessment "advantage risk" of medicine;

19) post-registration research of safety - the research concerning the registered medicine, conducted for the purpose of determination, the characteristic or quantitative assessment of safety hazard, confirmation of profile of safety of medicine or efficiency evaluation of measures for risk management;

20) problem on safety - important identifiable risk, important potential risk or the important absent information;

21) safety profile - set of indicators of use of medicine, allowing to determine ratio "advantage risk" of medicine;

22) unfavorable event (incident) - any defect and (or) deterioration in characteristics or violation of functioning of medical product, either insufficiency or incorrectness of accompanying information (documentation) on the medical product, side effects or undesirable reaction which are not specified in the instruction for application or the operation manual which directly or indirectly brought or could lead to death or serious deterioration in the state of health of users or the third parties;

23) corrective action on safety of medical product - the action taken by the producer of medical products for the purpose of decrease in risk of death or serious deterioration in the state of health of users or the third parties, connected using medical product are also included: return of medical product to the producer of medical products or to his authorized representative; modification of medical product (upgrade according to the changes in design of medical product made by the producer of medical products, change of instructions for application, updating of the software of medical product); replacement of medical product; withdrawal of medical product from the address; destruction of medical product; informing on actions of users of medical products if the medical product is withdrawn from circulation, but is available probability of its use;

24) the notification on safety of medical product - the message sent by the producer of medical products or his authorized representative to subjects of the address of medical product in connection with corrective action on safety of medical product;

25) the producer of medical product - the subject in the sphere of drug circulation and medical products, responsible for development and production of medical product, making it available for use on its own behalf irrespective of, it is developed and made by this person or from his name other person (persons), and bearing responsibility for its safety, quality and efficiency;

26) the authorized representative of producer - the legal entity or physical person registered as the individual entrepreneur, which is resident of the Republic of Kazakhstan, authorized by the power of attorney of the producer of medical product to represent its interests concerning the address of medical product in the territory of the Republic of Kazakhstan according to the current legislation of the Republic of Kazakhstan in the field of health care;

27) the user - the patient, the medical specialist or any other physical person applying medical product to destination, determined by the producer of medical products;

28) ratio "advantage risk" - assessment of positive therapeutic effects of medicine in relation to the risks connected with its application (the concept of risk includes any risk connected with quality, safety or efficiency of medicine in relation to health of the patient or the population);

29) the identified risk - undesirable consequence of pharmacotherapy concerning which the adequate evidence of availability of interrelation with the suspected medicine is obtained;

30) cause and effect relationship - interrelation between clinical manifestations of any undesirable reaction including after immunization and use of medicine, vaccine, determined by the commonly accepted criteria (criteria of the World Health Organization, Naranzhi's scale, binary method);

31) the risk management plan - the detailed description of risk management system;

32) the holder of the registration certificate - the legal entity addressed to whom the registration certificate on medicine is issued;

33) corrective action - action taken by the producer of medical products for the purpose of elimination of the reason of the found discrepancy or undesirable event;

34) pharmakonadzor - the type of activity directed to identification, the analysis, assessment and prevention of undesirable consequences of use of medicines;

35) inspection of system of pharmakonadzor - the procedure of check of system of pharmakonadzor of the holder of the registration certificate on compliance to requirements of proper practice of pharmakonadzor of the Republic of Kazakhstan;

36) the master file of system of pharmakonadzor - the detailed description of the system of pharmakonadzor applied by the holder of the registration certificate concerning data on one or several registered medicines.

Chapter 2. Procedure for carrying out pharmakonadzor

Paragraph 1. Identification, analysis and assessment of messages on undesirable consequences of use of medicine

4. Carrying out pharmakonadzor is provided with authorized body in the field of health care and is directed to identification, the analysis, assessment and prevention of undesirable consequences of use of medicines.

5. Data on undesirable consequences of use of medicine, including vaccines are provided by subjects of health care, subjects in the sphere of drug circulation and medical products, and also holders of registration certificates of medicines in the form of the Map message about undesirable reactions of medicine (further - the map message) in form according to appendix 1 to these rules.

Maps messages contain the obligatory minimum amount of information required for establishment of assessment of cause and effect relationship between use of medicine and development of undesirable reactions.

6. Maps messages are transmitted through Internet resource of the expert organization online (further - the portal), by means of the fax, e-mail or are provided purposely in the expert organization on paper.

7. For receipt of access to the portal for the purpose of transfer of maps messages in the expert organization:

1) subjects of health care represent the list of the medical organizations with indication of data of the responsible person for monitoring of undesirable reactions of medicine;

2) territorial departments of state body in the sphere of drug circulation and medical products represent the list of the pharmaceutical organizations with indication of data of the responsible person for monitoring of undesirable reactions of medicine;

3) holders of the registration certificate of medicine represent data of the authorized and contact person on pharmakonadzor in the territory of the Republic of Kazakhstan.

8. Terms of provision of the map message in identification cases in the territory of the Republic of Kazakhstan:

1) serious undesirable reaction - within 48 hours from the moment of approach of case (for medical institutions and the organizations of health care) and within 15 calendar days from the moment of receipt of information (for holders of RU);

2) undesirable reaction - within 15 calendar days from the moment of approach of case;

3) the serious unforeseen undesirable reaction (further - SNNR) on the researched medicine revealed during clinical trials - within 7 calendar days of the date of receipt of information on identification of SNNR if they led to death or posed threat for life and till 15 calendar days of the date of receipt of information for other SNNR.

If terms of provision of the map message from the moment of receipt of information fall on output or festive days, information is provided in the first after it the working day.

9. In case of SNNR on medicine which occurred outside the Republic of Kazakhstan and led to the death of the patient and (or) threat of life of the patient, the holder of the registration certificate within 15 calendar days from the date of receipt of information sends to the expert organization the Report on cases of the serious unforeseen undesirable reaction of medicine revealed out of the territory of the Republic of Kazakhstan in form according to appendix 2 to these rules.

10. The expert organization carries out processing, the analysis and assessment of the received maps messages.

11. When processing of the received maps messages about the undesirable reactions revealed in the territory of the Republic of Kazakhstan, the expert organization performs:

1) validation of the map message (availability of the minimum amount of obligatory information);

2) verification of information in the map message;

3) detection of duplicative maps messages;

4) registration of the map message in the electronic database of the expert organization;

5) registration of undesirable reaction of medicine in the course of performing clinical trial;

6) the direction to subjects of health care and (or) to subjects in the sphere of drug circulation and medical products, and also to holders of registration certificates of medicines of request about provision of the additional information including primary medical documentation, the card of epidemiological investigation, and also samples of the suspected medicine.

12. The analysis and assessment of maps messages are carried out by the expert organization and provide establishment of cause and effect relationship according to classification of the World Health Organization (further - WHO) on time (or to the place) between use of medicine and development of undesirable reaction and includes:

1) data analysis of the map message;

2) the analysis of the additional data obtained from the medical organization, the health or pharmaceutical worker and provided by the holder of the registration certificate (information on cause and effect relationship);

3) assessment of results of additional examination of quality and safety of samples of medicine according to procedure, stipulated in Item 2 articles 84 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further - the Code).

13. In case of receipt of the map message about serious undesirable reaction the expert organization sends the relevant information to state body within 48 hours from the moment of processing and validation of the map message.

In case of the translation of undesirable reaction from category of serious undesirable reaction in frivolous undesirable reaction the expert organization sends the relevant information to state body within 15 calendar days.

If terms of provision of the map message from the moment of receipt of information fall on output or festive days, information is provided in the first after it the working day.

14. The expert organization within 60 calendar days carries out assessment of cause and effect relationship and sends to state body the Expert opinion according to cause and effect relationship between undesirable reaction and use of medicine in form according to appendix 3 to these rules.

15. The expert organization monthly sends to state body the Report on the arrived maps messages on form according to appendix 4 to these rules.

16. By official request of the holder of the registration certificate the expert organization provides information on all arrived maps messages on medicine for the period specified in the written request.

17. For identification of the signal connected with safety of medicine, the expert organization cooperates with the international organizations and on permanent basis performs systematic studying of data of scientific and medical literature (foreign and local editions), the websites of regulatory bodies of other countries, WHO.

18. Identification and assessment of signal provides studying of all available information (pharmacological, medical, epidemiological) on the corresponding signal.

The overview of information includes available scientific and clinical data, including data of the registration file of medicine, Article in medical literature, spontaneous messages and information from holders of registration certificates and regulatory bodies of other countries. In case of receipt of information from several sources, the level of their substantiality is considered.

19. The signal is considered validirovanny if process of verification of all available information demonstrates presumably new cause and effect relationship or new aspect of the known interrelation, therefore, is reasons for further assessment.

20. By results of signal assessment the expert organization sends to state body and to the holder of the registration certificate the relevant information including measures of advisory nature:

1) about suspension of action of the registration certificate of medicine before completion of assessment of signal in the presence of potential hazard to health of the person and (or) public health care;

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