ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 8, 2019 No. KR DSM-69

About approval of Rules of ethical promotion of medicines and medical products

According to subitem 67-1) of Item 1 of article 7 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 ethical promotion of medicines and medical products.

2. To provide to committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation:

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 in the Ministry of Justice of the Republic of Kazakhstan the direction it the copy in paper and electronic type 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 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 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 order on the vice-Minister of Health of the Republic of Kazakhstan Nadyrov K. T.

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

No. KR DSM-69 are approved by the Order of the Minister of Health of the Republic of Kazakhstan of May 8, 2019

Rules of ethical promotion of medicines and medical products

Chapter 1. General provisions

1. These rules of ethical promotion of medicines and medical products (further - Rules) determine procedure for ethical promotion of medicines and medical products.

2. The basic concepts used in Rules:

1) 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;

2) drug circulation - the activities including processes of development, preclinical (not clinical) researches, testing, clinical trials, examinations, registration, pharmakonadzor, quality control, production, production, storage, transportation, import and export, leave, realization, transfer, application, destruction of medicines;

3) advertizing of medicines and medical products - the information distributed and placed in any form, by means of any means, separate data or the set of data on medicines and medical products intended for the uncertain group of people, containing promoting their promotion and realization;

4) ethical promotion of medicines and medical products - the activities performed in the course of promotion of safe, high-quality and effective medicines, and medical products from developer and (or) producer of medicine or medical product before application by the consumer, based on fair competition and responsibility of all parties concerned;

5) objects in the sphere of drug circulation and medical products - drugstore, pharmaceutical Item in the organizations of health care rendering primary medical and sanitary and (or) consulting and diagnostic help, the mobile pharmaceutical unit for the remote rural zones organized from drugstore, pharmaceutical (distributor) warehouse, warehouse of temporary storage of medicines, medical products, shop of optics, shop of medical products, warehouse of medical products, the organizations for production of medicines and medical products;

6) subjects in the sphere of drug circulation and medical products - the physical persons or legal entities performing pharmaceutical activities;

7) producer of medicines - the organization which is performing activities for production of medicines and having the license for production of medicines;

8) 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;

9) subjects of health care - the organizations of health care, and also the physical persons practising private medicine and pharmaceutical activities;

10) daily medical conference - planned meeting of the medical organization for the purpose of summing up for last days, discussions and analysis of clinical cases, and also informing collective on new achievements of medical science and clinical practice;

11) medical products - any tools, devices, devices, the equipment, materials and other products which are applied in the medical purposes separately or in combination among themselves, and also with the accessories necessary for application of the specified products to destination, including the special software are intended by the producer of medical product for prevention, diagnostics, treatment of diseases, medical rehabilitation and monitoring of condition of human body, carrying out medical researches, recovery, replacement, change of anatomical structure or physiological functions of organism, prevention or termination of pregnancy and which functional purpose is not implemented by pharmacological, immunological, genetic or metabolic impact on human body, and can be supported by use of medicines;

12) the address of medical products - designing, development, creation of prototypes, carrying out technical testing, researches (testing) of assessment of biological effect of medical products, clinical trials, examinations of safety, quality and efficiency of medical products, registration, production (production), storage, transportation, realization, installation, adjustment, application (operation), maintenance, repair and utilization of medical products;

13) 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;

14) the patient - the physical person which is (being) the consumer of medical services;

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