of June 14, 2019 No. KR DSM-94
About approval of Rules of implementation of activities of form system
According to Item 2 of article 86-2 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 implementation of activities of form system.
2. Declare invalid the order of the Minister of health and social development of the Republic of Kazakhstan of December 6, 2016 No. 1037 "About approval of the Regulations on the Form commission of the Ministry of health and social development of the Republic of Kazakhstan" (it is registered in the Register of state registration of regulatory legal acts for No. 14641, it is published on January 12, 2017 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan in electronic form).
3. To provide to department of provision of medicines and standardization of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation 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 from the date of state registration of this order the direction in paper and electronic type in the state and Russian languages in the Republican state company on the right of economic maintaining "Institute of the legislation and legal information of the Republic of Kazakhstan" the Ministries of Justice of the Republic of Kazakhstan for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;
3) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan;
4) within ten working days after state registration of this order 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.
4. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Nadyrov K. T.
deputy. Minister of Health of the Republic of Kazakhstan
Approved by the Order of the Minister of Health of the Republic of Kazakhstan of June 14, 2019, No. KR DSM-94
1. These rules of implementation of activities of form system (further - Rules) are developed according to Item 2 of article 86-2 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code), and determine procedure of activities of form system in the Republic of Kazakhstan.
2. In these rules the following concepts are used:
1) the list of medicines and medical products for free and (or) preferential out-patient ensuring separate categories of citizens with certain diseases (conditions) - the list of medicines, medical products and the specialized medical products bought at the expense of budgetary funds and assets of fund of social medical insurance within the guaranteed amount of free medical care and in system of compulsory social medical insurance for rendering the out-patient and polyclinic help, including names and characteristics of medicines, medical products and specialized medical products by separate categories of citizens with certain diseases (conditions);
2) medicine - the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;
3) rational use of medicines - the drug treatment corresponding to clinical indications in the doses meeting individual needs of the patient during the sufficient period of time and in case of the smallest costs;
4) the proved clinical efficiency of medicinal medicine - the pharmacological effect in the therapeutic purposes proved in meta-analyses and (or) systematic reviews and (or) randomized controlled clinical trials;
5) the international unlicensed name of medicine - the name of medicine recommended by the World Health Organization;
6) subjects of health care - the organizations of health care, and also the physical persons practising private medicine and pharmaceutical activities;
7) 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;
8) the medicinal form of the organization of health care - the list of medicines for delivery of health care within the guaranteed amount of free medical care and in system of compulsory social medical insurance, created on the basis of the Kazakhstan national medicinal form and approved as the head of the organization of health care according to the procedure, determined by authorized body;
9) the clinical pharmacologist - the specialist with the higher medical education in the profiles "medical case", "pediatrics", "general medicine" who studied residency or retraining in clinical pharmacology and having the certificate of the specialist of the clinical pharmacologist;
10) the Kazakhstan national medicinal form - the list of medicines with the proved clinical safety and efficiency, and also orphan (rare) medicines which is obligatory basis for development of medicinal forms of the medical organizations and forming of lists of purchase of medicines within the guaranteed amount of free medical care and in system of compulsory social medical insurance;
11) the joint commission on quality of medical services - permanent advisory advisory body under authorized body;
12) form system - the system of periodic assessment and selection of medicines for medicinal forms, maintenance of medicinal forms and submission of information in the form of the corresponding management and the list directed to rational use of medicines.
3. Rational use of medicines is carried out for improvement of quality of medical care and results of treatment by development of form system.
4. The form system provides optimum use of safe, effective, economically available medicines.
5. The form system is provided by three levels:
1) republican level is provided by the Form commission of authorized body, the Kazakhstan national medicinal form and its Internet resource, assessment of rational use of medicines;
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