of December 21, 2020 No. KR DSM-294/2020
About approval of rules of ethics of promotion of medicines and medical products
According to Item 2 of article 265 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" PRIKAZYVAYU:
1. Approve the enclosed rules of ethics of promotion of medicines and medical products.
2. Declare invalid the 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" (it is registered in the Register of state registration of regulatory legal acts at No. 18654, it is published on May 16, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan).
3. To provide to department of medicinal policy of the Ministry of Health of the Republic of Kazakhstan in the procedure for the Republic of Kazakhstan established by the legislation:
1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;
3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan provision in Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.
4. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.
Minister of Health of the Republic of Kazakhstan
to the Order of the Minister of Health of the Republic of Kazakhstan of December 21, 2020 No. KR DSM-294/2020
1. These rules of ethics of promotion of medicines and medical products (further - Rules) are developed according to Item 2 of article 265 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" (further - the Code) and determine procedure for ethics of promotion of medicines and medical products.
2. In these rules the following basic concepts are used:
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) ethics of 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 - the drugstore including enabling the realization on the Internet, pharmaceutical Item in the organizations of health care, 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) the authorized person of the producer of medicines - the person who is responsible for providing and quality control of the medicines made by the producer according to the legislation of the Republic of Kazakhstan in the field of health care, and entered the register of authorized persons of producers of medicines;
9) 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 of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, qualities of rendering medical services (help);
10) subjects of health care - the organizations of health care, and also the physical persons practising private medicine and pharmaceutical activities;
11) 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;
12) medical products - products of medical appointment and medical equipment;
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 irrespective of availability or absence at it of the disease or condition requiring delivery of health care;
15) pharmaceutical workers - the physical persons having pharmaceutical education and performing pharmaceutical activities;
16) the health worker - the physical person having professional medical education and performing medical activities.
3. These rules extend to health care subjects, subjects in the sphere of drug circulation and medical products, health and pharmaceutical workers, members of professional associations.
Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info
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