JOINT ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN AND MINISTER OF NATIONAL ECONOMY OF THE REPUBLIC OF KAZAKHSTAN

of April 29, 2019 No. KR DSM-56, 30 of April, 2019 No. 33

About introduction of amendments to the joint order of the Minister of Health of the Republic of Kazakhstan of November 15, 2018 No. KR DSM-32 and the Minister of national economy of the Republic of Kazakhstan of November 15, 2018 No. 70 "About approval of criteria for evaluation of risk degree and checking sheets in spheres of quality of rendering medical services, drug circulation, products of medical appointment and medical technicians"

According to Item 3 of Article 141, Item 1 of article 143 of the Entrepreneurial code of the Republic of Kazakhstan of October 29, 2015 we ORDER:

1. Bring in the joint order of the Minister of Health of the Republic of Kazakhstan of November 15, 2018 No. KR DSM-32 and the Minister of national economy of the Republic of Kazakhstan of November 15, 2018 No. 70 "About approval of criteria for evaluation of risk degree and checking sheets in spheres of quality of rendering medical services, drug circulation, products of medical appointment and medical technicians" (it is registered in the Register of state registration of regulatory legal acts at No. 17744, it is published on November 23, 2018 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan in electronic form) the following changes:

state heading in the following edition:

"About approval of criteria for evaluation of risk degree and checking sheets in spheres of quality of rendering medical services, drug circulation and medical products";

in Criteria for evaluation of risk degree in the field of quality of rendering the medical services approved by the specified joint order:

state Items 7 and 8 in the following edition:

"7. Subjects (objects) of control rendering stationary (except for subjects (objects) rendering recovery treatment, medical rehabilitation, palliative care and sisterly leaving), hospital-replacing (except for subjects (objects) rendering recovery treatment, medical rehabilitation, palliative care and sisterly leaving), out-patient and polyclinic (except for subjects (objects) rendering recovery treatment, medical rehabilitation, the specialized dermatokosmetologichesky help using invasive methods and use of medicines and medical products, the pre-medical help), dental, narcological, psychiatric, ftiziatrichesky, oncological, cardiac, emergency medical service, including in the form of sanitary aircraft, the organizations rendering laboratory services, the help to HIV-positive people, services of blood belong to high risk.

8. Not carried to high risk - subjects (objects) of control performing the recovery treatment, medical rehabilitation giving pre-medical help, palliative care and sisterly leaving, traditional medicine; the organizations giving specialized dermatokosmetologichesky help using invasive methods and use of medicines and medical products.";

to be reworded as follows the criteria for evaluation of risk degree in the field of drug circulation, products of medical appointment and medical equipment approved by the specified joint order according to appendix 1 to this joint order;

to be reworded as follows the checking leaf in the field of drug circulation, products of medical appointment and medical equipment concerning all subjects (objects) of pharmaceutical activities approved by the specified joint order according to appendix 2 to this joint order;

to be reworded as follows the checking leaf in the field of drug circulation, products of medical appointment and medical equipment concerning the medical organizations for provision of medicines approved by the specified joint order according to appendix 3 to this joint order;

to be reworded as follows the checking leaf in the field of drug circulation, products of medical appointment and medical equipment concerning subjects (objects) of pharmaceutical activities performing production of medicines, products of medical appointment and medical equipment approved by the specified joint order according to appendix 4 to this joint order;

to be reworded as follows the checking leaf in the field of drug circulation, products of medical appointment and medical equipment concerning subjects (objects) of pharmaceutical activities performing production of medicines and products of medical appointment approved by the specified joint order according to appendix 5 to this joint order;

to be reworded as follows the checking leaf in the field of drug circulation, products of medical appointment and medical equipment concerning subjects (objects) of pharmaceutical activities enabling wholesale of medicines, products of medical appointment and medical equipment approved by the specified joint order according to appendix 6 to this joint order;

to be reworded as follows the checking leaf in the field of drug circulation, products of medical appointment and medical equipment concerning subjects (objects) of pharmaceutical activities enabling retail sale of medicines, products of medical appointment and medical equipment approved by the specified joint order according to appendix 7 to this joint order.

2. To provide to committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan:

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

2) within ten calendar days from the date of state registration of this joint order the direction it the copy in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "The republican center of legal information" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) placement of this joint order on official Internet resources of the Ministry of Health of the Republic of Kazakhstan and the Ministry of national economy of the Republic of Kazakhstan after its official publication;

4) within ten working days after state registration of this joint order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.

3. To impose control of execution of this joint order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

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

Appendix 1

to the Joint Order of the Minister of Health of the Republic of Kazakhstan and the Minister of national economy of the Republic of Kazakhstan of April 29, 2019 No. KR DSM-56, 30 of April, 2019 No. 33

Appendix 16

to the Joint Order of the Minister of Health of the Republic of Kazakhstan and the Minister of national economy of the Republic of Kazakhstan of November 15, 2018 No. KR DSM-32, 15 of November, 2018 No. 70

Criteria for evaluation of risk degree in the field of drug circulation and medical products

Chapter 1. General provisions

1. These Criteria for evaluation of risk degree in the field of drug circulation and medical products (further - Criteria) are developed according to the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", the Entrepreneurial code of the Republic of Kazakhstan of October 29, 2015 and Rules of forming by the state bodies of system of risks assessment and form of checking sheets approved by the order of the acting minister of national economy of the Republic of Kazakhstan on July 31, 2018 No. 3 (registered in the Register of state registration of regulatory legal acts of the Republic of Kazakhstan No. 17371).

2. In these Criteria the following concepts are used:

1) assessment period - certain time period for which the risks assessment by objective and subjective criteria based on results of the previous checks / preventive control, analysis results of data and other sources of information is carried out. For the organizations performing activities in the field of drug circulation and medical products assessment period used in Criteria - 3 years, previous by the accounting period;

2) insignificant violations - the violations which are not relating to rough and considerable;

3) risk in the field of drug circulation and medical products - probability of damnification of life or to health of the person as a result of production, production, import, export, transportation, storage, wholesale and retail sale, application (use) of the medicines which are not conforming to requirements of the legislation of the Republic of Kazakhstan and medical products, taking into account severity of its effects;

4) subjects (objects) of control in the field of drug circulation and medical products - the organizations of health care, and also the physical persons and legal entities which are engaged in pharmaceutical and medical activities (further - subjects (objects) of control;

5) considerable violations - violations, including the discrepancies to requirements of the legislation in the field of health care causing or resulting in risk of change of quality of medicine and medical product in the course of its address, insufficient execution of actions (procedures) confirming quality and safety of medicines and medical products, and also non-compliance with the requirements connected with determination of requirement and rational use of medicines and medical products within the guaranteed amount of free medical care; availability of negative responses about quality of rendering pharmaceutical services;

6) gross violations - violations, including the discrepancies to requirements of the legislation in the field of health care causing or leading to essential change of quality of medicine and medical product in the course of its address hazardous to health and human life to pollution, pereputyvaniye and cross contamination; the discrepancy connected with the address of drugs, psychotropic substances and precursors; not observance of requirements for confirmation of quality and safety of medicines and medical products; availability of the confirmed claims and addresses, the facts of attraction to administrative and criminal liability; not marginal respect for price on the trade name of medicine in case of wholesale and retail sale;

7) subjective criteria for evaluation of risk degree (further - subjective criteria) - the criteria for evaluation of risk degree used for selection of subjects (objects) of control in the field of drug circulation and medical products depending on results of activities of specific subject (object) of control;

8) objective criteria for evaluation of risk degree (further - objective criteria) - the criteria for evaluation of risk degree used for selection of subjects (objects) of control in the field of drug circulation and medical products depending on risk degree and which are not depending directly on separate subject (object) of control.

3. Criteria for evaluation of risk degree for preventive control with visit of subject (object) are created by means of objective and subjective criteria.

Chapter 2. Objective criteria

4. Objective criteria are created by means of the following stages:

1) risk identification;

2) distribution of subjects (objects) of control on risk degrees (high and not carried to high).

5. Risk identification is performed taking into account the following objective criteria:

1) possibilities of adverse effect on life and health of the person, legitimate interests of physical persons and legal entities, states;

2) scales of weight of possible negative effects of harm in the course of implementation of pharmaceutical activities.

6. After risk identification, subjects (objects) of control are distributed on two risk degrees (high and not carried to high).

Subjective criteria for the purpose of carrying out preventive control with visit of subject (object) of control are applied to subjects (objects) of control carried by objective criteria to high risk.

7. Subjects (objects) of control performing activities belong to high risk:

1) connected with production of medicines and medical products;

2) connected with production of medicines and medical products;

3) connected with wholesale of medicines;

4) connected with retail sale of medicines;

5) connected with production, wholesale and retail sale of the medicines containing drugs, psychotropic substances and precursors;

6) the medical organizations performing purchase, storage, distribution, use (application) of medicines and medical products.

8. Subjects (objects) having certificates of proper production practice (GMP), proper distributor practice (GDP), proper pharmaceutical practice (GPP) concern to group of subjects (objects) of control which are not relating to high risk; the legal entities and physical persons performing the pharmaceutical activities connected with wholesale and retail sale of medical products.

Chapter 3. Subjective criteria

9. Determination of subjective criteria in the field of drug circulation and medical products is performed using the following stages:

1) forming of the database and information collection;

2) information analysis and risks assessment.

10. For assessment of risk degree the following sources of information are used:

1) results of the previous checks / preventive control with visit of subject (object) of control;

2) availability and the number of the confirmed claims and addresses;

3) the analysis of official Internet resources of state bodies, including authorized bodies in the field of health care of countries of the Commonwealth of Independent States (CIS), mass media;

4) the list of the revealed violations by results of the laboratory researches which are carried out by the state expert organization in the field of drug circulation and medical products and its branches;

5) analysis results of the data represented by authorized bodies (prosecutor's office, law enforcement agencies), the state organizations;

6) availability of the adverse incidents which arose because of the subject of control. Treat adverse incidents probability of damnification to health, threat of life or to health of the person, as a result of production, production, import, storage, realization, use (use) of medicines and medical products, including, not conforming to requirements of the legislation of the Republic of Kazakhstan in the field of health care;

7) information of the international regulatory bodies in the field of quality and safety of medicines and medical products, state bodies of the countries, including the Eurasian Economic Union;

11. Based on the available sources of information, their analysis, singularity or systemacity of violation, the analysis of the made decisions subjective criteria for evaluation of risk degree in the field of drug circulation and medical products are subdivided into three extents of violation: gross, considerable, insignificant violations. Subjective criteria for evaluation of risk degree in the field of drug circulation and medical products are given in appendix to these Criteria.

12. The following procedure of payments of exponent of risk is applied to reference of the subject of control to risk degree.

In case of identification of one gross violation, to the subject of control the exponent of risk 100 is equated and concerning it preventive control with visit of subject (object) is carried out.

If gross violations are not revealed, for measure definition of risk degree the total indicator on violations of considerable and insignificant degree is calculated.

In case of measure definition of considerable violations the coefficient of 0,7 is applied and this indicator is calculated by the following formula:

Рз = (P2 x 100/P1) x 0,7

where:

 Рз - indicator of considerable violations;

P1 - the required number of considerable violations;

P2 - the number of the revealed considerable violations;

In case of measure definition of insignificant violations the coefficient of 0,3 is applied and this indicator is calculated by the following formula:

Рн = (P2 x 100/P1) x 0,3

where:

Рн - indicator of insignificant violations;

P1 - the required number of insignificant violations;

P2 - the number of the revealed insignificant violations;

The general exponent of risk (R) is calculated on scale from 0 to 100 and is determined by summing of indicators of considerable and insignificant violations by the following formula:

Р = Рз + Rn

where:

Р - general exponent of risk;

Рз - indicator of considerable violations;

Рн - indicator of insignificant violations.

13. On risk exponents the subject (object) of control belongs:

1) to high risk - in case of exponent of risk from 61 to 100 inclusive and concerning it preventive control with visit of subject (object) is carried out;

2) not carried to high risk - in case of exponent of risk from 0 to 60 inclusive and concerning it preventive control with visit of subject (object) is not carried out.

14. Frequency rate of carrying out preventive control with visit of subject (object) is determined by results of the carried-out annual analysis and assessment of the received data on subjective criteria and cannot be more often than once a year.

15. Preventive control with visit of subject (object) of control are carried out based on the semi-annual lists of preventive control with visit of subject (object) of control created according to Item 3 of article 141 of the Entrepreneurial code.

16. The basis for purpose of preventive control with visit of subject (object) of control is the semi-annual list of carrying out preventive control with visit of subject (object) of control approved by the first head of regulatory state agency.

17. Semi-annual lists of carrying out preventive control with visit of subject (object) of control are created concerning subjects of control with obligatory specifying of objects concerning which preventive control with visit of subject (object) of control is appointed.

18. Lists of carrying out preventive control with visit of subject (object) are constituted taking into account priority of subjects (objects) of control with the greatest exponent of risk by subjective criteria.

Appendix

to Criteria for evaluation of risk degree in the field of drug circulation and medical products

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