HEALTHCARE AND PHARMACEUTICALS

Promotion is carried out by the manufacturer, the distributor or their authorised representatives, and by other entities in the sphere of circulation of medicines and medical devices vested with the corresponding powers. It takes place through interaction between those entities and with healthcare entities and members of professional associations. All of them must ensure ethical promotion, distribute advertising in accordance with the law, and provide professional training and development for their representatives, including on ethics of promotion.

Legal basisParas. 4 and 5 of the Rules on the ethics of promoting medicines and medical devices

The Rules give a closed list: offering or providing medical and pharmaceutical workers financial reward or any other material or non-material incentive for prescribing and dispensing particular medicines; paying for entertainment, leisure and travel to a place of leisure, other than payments connected with scientific and educational activity; concluding agreements and running campaigns to have medical workers prescribe or recommend products to patients for material gain; providing samples of medicines and medical devices to patients; inducing prescriptions on non-standard prescription forms, including forms carrying advertising or pre-printed product names; and running schemes awarding prizes and gifts to heads of pharmacies and pharmaceutical workers for achieving sales results.

Legal basisPara. 18 of the Rules on the ethics of promoting medicines and medical devices

No. The Rules expressly exclude individual contacts between manufacturers, distributors, their authorised representatives and other entities vested with promotion powers and medical and pharmaceutical workers during their working hours and at their workplace for the purpose of promoting medicines and medical devices. The head of the healthcare organisation is responsible for ensuring that medical workers comply with the Rules in such interactions.

Legal basisParas. 12 and 13 of the Rules on the ethics of promoting medicines and medical devices

To take part in daily medical conferences at healthcare and medical education organisations, representatives of manufacturers or distributors must agree the time and topic of the event in writing with the head of the healthcare organisation ten calendar days before the planned participation. A daily medical conference is a scheduled meeting of a medical organisation to review the past twenty-four hours, discuss clinical cases and inform staff of new developments in medical science and clinical practice.

Legal basisPara. 9 and sub-para. 11) of para. 2 of the Rules on the ethics of promoting medicines and medical devices

Yes, subject to conditions. Support may be given for participation in scientific and practical conferences, congresses and symposia matching the profile of the healthcare entity. However, such support must not be made conditional on any obligation to assist in promoting medicines or medical devices, and the entity signs an agreement with the worker confirming that the travel costs impose no promotion obligations. Paying for entertainment, leisure and travel to a place of leisure unconnected with scientific and educational activity is a breach of promotion ethics.

Legal basisSub-para. 2) of para. 8 and sub-para. 2) of para. 18 of the Rules on the ethics of promoting medicines and medical devices

In dealings between representatives of manufacturers and distributors and pharmaceutical workers at retail outlets, the following are permitted: informing pharmaceutical workers about the products manufactured or sold; placing over-the-counter medicines and medical devices in a particular way in the display window of the pharmacy's sales area; placing information and advertising in the pharmacy and on its website in compliance with the law and the Rules; and conducting marketing research. Note that only over-the-counter medicines may be placed in the display window.

Legal basisPara. 17 of the Rules on the ethics of promoting medicines and medical devices

Yes. When presenting the results of clinical, post-marketing or other medical research at scientific and practical conferences, congresses and symposia, the speaker discloses any conflict of interest with entities in the sphere of circulation of medicines and medical devices. In addition, at scientific events funded by such an entity, other entities that manufacture or sell products with a similar pharmacological mechanism must not be prevented from participating, and individual participants must not be discriminated against.

Legal basisParas. 10 and 11 of the Rules on the ethics of promoting medicines and medical devices

Permitted are complete, objective, accurate and substantiated information in the form of reference and medical literature and scientific journals during medical and scientific conferences and specialised seminars, scientific and information materials, and instructions for medical use of registered products — including products not registered in Kazakhstan where they are used on vital indications for a named patient or to treat a limited group of patients with rare (orphan) diseases. Also permitted are creating patient registers in strict compliance with personal data legislation and the medical worker's duty of confidentiality, concluding contracts for clinical, clinical-economic and epidemiological research, and conducting marketing research.

Legal basisPara. 8 of the Rules on the ethics of promoting medicines and medical devices

State registration, re-registration and amendment of the registration dossier are carried out by the state body in the sphere of circulation of medicines and medical devices through the e-government portal, interacting with the Medicines Management System of the Unified Healthcare Information System. The applicant files an application in the prescribed form certified by an electronic digital signature. Registration follows an expert review conducted under separate rules on the expert review of medicines and medical devices.

Legal basisParas. 3, 3-1 and 4 of the Rules on state registration and re-registration of a medicine or medical device

The state service is provided through the portal within five working days. Where an applicant applies outside working hours or on weekends and public holidays, applications are accepted and results issued on the following working day. Within two working days of receiving the documents, the responsible unit checks that the set is complete and meets the requirements and prepares a draft permit document or a decision refusing registration.

Legal basisPara. 7 of the Rules on state registration and re-registration of a medicine or medical device

An application for re-registration, including for the expert review required for it, is filed before the marketing authorisation expires. Missing that deadline means the product must go through registration afresh.

Legal basisPara. 6 of the Rules on state registration and re-registration of a medicine or medical device

These are medicines and medical devices intended for use in conditions of military action and the elimination of its consequences; the occurrence, prevention and elimination of the consequences of emergencies; the threat of the emergence and spread of new particularly dangerous infectious diseases; the prevention, diagnosis and treatment of diseases and injuries caused by adverse chemical, biological and radiation factors; and the absence or threatened absence of products on the markets of the Eurasian Economic Union member states where restrictive economic measures have been imposed on at least one member state.

Legal basisSub-para. 4) of para. 2 of the Rules on state registration and re-registration of a medicine or medical device

The Rules were developed in accordance with the Rules on registration and expert review of the safety, quality and efficacy of medical devices approved by Decision of the Council of the Eurasian Economic Commission No. 46 of 12 February 2016, the Rules on registration and expert review of medicines for medical use approved by Decision No. 78 of 3 November 2016, Decision No. 96 of 10 June 2022 on temporary measures, Article 23 of the Code on Public Health, Articles 73 and 91 of the Administrative Procedural Code, and the Law on State Services.

Legal basisPara. 1 of the Rules on state registration and re-registration of a medicine or medical device

To register a medical device the applicant selects a reference state and at least one state of recognition. The applicant files with the authorised body or expert organisation of the reference state a registration dossier containing the applications for registration and expert review and the documents on the prescribed list, together with copies of documents confirming payment for the registration and expert review procedures in the reference state.

Legal basisParas. 21 and 22 of the Rules on registration and expert review of the safety, quality and efficacy of medical devices (EEC Council Decision No. 46)

A state of recognition is a member state whose authorised body or expert organisation carries out the procedure for approving the expert opinion of the reference state. The reference state conducts the substantive expert review, and the states of recognition endorse its result. This structure allows a device to be registered once and then recognised in other member states of the Union.

Legal basisSection I of the Rules on registration and expert review of the safety, quality and efficacy of medical devices (EEC Council Decision No. 46)

The authorised body or expert organisation of the reference state checks the completeness and accuracy of the information within seven working days of receiving the applications for registration and expert review and the accompanying documents.

Legal basisPara. 23 of the Rules on registration and expert review of the safety, quality and efficacy of medical devices (EEC Council Decision No. 46)

The class of potential risk of use is a characteristic of the device confirmed during its expert review and stated in the registration certificate. The class determines the scope of testing required and the requirements for the manufacturer: the higher the class, the broader the programme for assessing safety and efficacy.

Legal basisRules on registration and expert review of the safety, quality and efficacy of medical devices (EEC Council Decision No. 46)

The fee for the procedures is set having regard to their complexity and the volume of work carried out in the reference state and the states of recognition, including work on amending the registration dossier of the medical device.

Legal basisRules on registration and expert review of the safety, quality and efficacy of medical devices (EEC Council Decision No. 46)

The maximum price of a trade name for wholesale sale is the price of a medicine included in the list of products subject to price regulation above which it may not be sold wholesale. The maximum price for retail sale is correspondingly the price above which such a product may not be sold at retail.

Legal basisSub-paras. 2) and 15) of para. 2 of the Rules on regulating and forming maximum prices and mark-ups for medicines

The retail mark-up is an addition to the maximum wholesale price of a trade name, applied on a regressive scale, covering profit and the costs of retail sale and used to form the maximum retail price. The regressive scale expresses the mark-up as a percentage that depends on the level of the maximum wholesale price: the more expensive the product, the lower the percentage.

Legal basisSub-paras. 3) and 4) of para. 2 of the Rules on regulating and forming maximum prices and mark-ups for medicines

The Rules set out the procedure for the state service «Registration of the price of medicines and medical devices». They were developed in accordance with the Code on Public Health and the Law on State and Socially Responsible Services and apply within the guaranteed volume of free medical care and the compulsory social health insurance system.

Legal basisPara. 1 of the Rules on regulating and forming maximum prices and mark-ups for medicines

An originator medicinal product is a product with a new active substance that was the first to be registered and placed on the world pharmaceutical market on the basis of a dossier containing the results of full pre-clinical and clinical studies confirming its safety, quality and efficacy. A biosimilar is a biological product containing a version of the active substance of a registered originator or reference product, for which similarity has been demonstrated through comparative studies of quality, biological activity, safety and efficacy.

Legal basisSub-paras. 1) and 5) of para. 2 of the Rules on regulating and forming maximum prices and mark-ups for medicines

Maximum prices for trade names of medicines and medical devices within the guaranteed volume of free medical care and the compulsory social health insurance system are approved by a separate order of the authorised body and published as a list. Before setting a pharmacy's or clinic's price list, prices should be checked against the current version of that order: the list is revised regularly.

Legal basisOrder approving maximum prices for trade names of medicines and medical devices within the guaranteed volume of free medical care and the compulsory social health insurance system

Licensing applies to medical activity; pharmaceutical activity; activity involving the circulation of narcotic drugs, psychotropic substances and precursors in healthcare; the import into Kazakhstan from states outside the Eurasian Economic Union and export to those states of human organs and parts of organs, tissues and parts of tissues, blood and its components; and the provision of disinfection, disinsection and deratisation services in healthcare. The procedure and conditions for issuing and reissuing a licence and its annex are determined by the Code and the legislation on permits and notifications.

Legal basisParas. 1 and 2 of Art. 17 of the Code of the RK on Public Health and the Healthcare System

Accreditation carried out by the state body in the sphere of medical services applies to healthcare entities that accredit medical organisations in order to confirm that the services provided meet the established requirements and standards; organisations assessing the knowledge and skills of students, graduates and specialists; healthcare entities carrying out independent expert review in healthcare; and legal entities confirming readiness for management activity by certifying healthcare managers.

Legal basisPara. 1 of Art. 25 of the Code of the RK on Public Health and the Healthcare System

In addition to the general rights, a patient has the right to dignified treatment during prevention, diagnosis and treatment and to respect for their cultural and personal values; to medical care in an order determined solely by medical criteria, free of discriminatory factors; to choose and change their doctor or medical organisation within the guaranteed volume of free medical care and the compulsory social health insurance system, except in emergency and urgent care; to be notified that audio and video monitoring and recording are carried out in the organisation; and to relief of suffering so far as existing means allow. The full list is in Article 134.

Legal basisPara. 1 of Art. 134 of the Code of the RK on Public Health and the Healthcare System

A patient must take steps to preserve and strengthen their health; show respect and tact in dealing with medical workers; give the doctor all information needed for diagnosis and treatment and, having consented to an intervention, strictly follow the medical workers' instructions; observe the internal rules and treat the organisation's property with care, cooperating with the staff; and inform medical workers promptly of any change in their state of health during diagnosis and treatment.

Legal basisPara. 1 of Art. 135 of the Code of the RK on Public Health and the Healthcare System

It covers personal medical data, information about the fact of seeking medical care, the person's state of health, the diagnosis and other information obtained during examination or treatment. Disclosure of such information by persons who learned it in the course of study or in performing professional, official or other duties is not permitted, save in the cases established by paragraphs 3 and 4 of Article 273.

Legal basisParas. 1 and 2 of Art. 273 of the Code of the RK on Public Health and the Healthcare System

With the informed consent of the patient or their statutory representative, the information may be passed on for scientific research and use in the educational process. Disclosure without the patient's consent is possible only in the cases expressly listed in paragraph 4 of Article 273. In other words, the patient's consent is the general rule and the list of exceptions is closed.

Legal basisParas. 3 and 4 of Art. 273 of the Code of the RK on Public Health and the Healthcare System

A patient or their statutory representative may refuse medical care, save in the cases provided for by Article 137. On refusal the medical worker explains the possible consequences in a form accessible to the patient. The refusal, together with the possible consequences, is recorded in the medical records, including in electronic form, and signed by the patient or their statutory representative and by the medical worker. Where the patient refuses to sign, the procedure set out in Article 136 applies.

Legal basisParas. 1, 2 and 3 of Art. 136 of the Code of the RK on Public Health and the Healthcare System

Remote medical services are provided to give advisory assistance, including by specialists of research institutes, scientific centres, university hospitals and foreign clinics; to determine whether the patient should be referred for an in-person consultation at a higher level of care; to give practical assistance by specialists of the secondary and tertiary levels to those of the primary level and rural healthcare; to assess the effectiveness of treatment and diagnostic measures and monitor the patient's health; and to clarify the diagnosis and adjust and determine further management.

Legal basisPara. 1 of Art. 129 of the Code of the RK on Public Health and the Healthcare System

It is a set of organisational, analytical and practical measures carried out to give an opinion on the level of quality of medical services, using indicators reflecting the effectiveness, completeness and conformity of services with standards. The review is internal or external. For internal review a patient support and internal review service is set up in the medical organisation, which carries out ongoing analysis of how medical care is organised.

Legal basisParas. 1, 2 and 3 of Art. 35 of the Code of the RK on Public Health and the Healthcare System

The guaranteed volume of free medical care is provided from budget funds to citizens of Kazakhstan, kandas, refugees, and foreign nationals and stateless persons permanently residing in the country. It covers preventive, diagnostic and treatment services with the greatest proven effectiveness, together with the supply of medicines. The list is approved by the Government. Foreign nationals and stateless persons temporarily present in Kazakhstan and persons seeking asylum are entitled to care in the scope set by the same article.

Legal basisPara. 1 of Art. 196 of the Code of the RK on Public Health and the Healthcare System

Yes. Healthcare entities must conclude a co-insurance contract covering the professional liability of medical workers. The insurance is arranged under a co-insurance contract between the healthcare entity and the participants of the single insurance or reinsurance pool. Note that this article is amended by the Law of 7 July 2026, with the amendments taking effect on 1 January 2027 — the terms should be checked against the version in force before the contract is concluded.

Legal basisParas. 1 and 2 of Art. 270-1 of the Code of the RK on Public Health and the Healthcare System

The authorised body ensures the functioning of the pharmacovigilance system and monitors the safety, quality and efficacy of medical devices in Kazakhstan. The state expert organisation in the sphere of circulation of medicines and medical devices collects, analyses, assesses and verifies reports of adverse reactions to medicines and adverse events involving medical devices received from healthcare entities, entities in the sphere of circulation and consumers, and assesses the benefit-risk balance on the basis of pharmacovigilance data.

Legal basisParas. 1 and 2 of Art. 261 of the Code of the RK on Public Health and the Healthcare System

The pharmaceutical inspectorate for good pharmaceutical practices comprises the structural units of the state body in the sphere of circulation of medicines and medical devices, its territorial units and the state expert organisation, which inspect compliance with good pharmaceutical practices for medicines and with the requirements for introducing, maintaining and assessing the quality management system for medical devices, depending on the potential risk of their use. Inspections carried out by the state expert organisation are classified as a state monopoly.

Legal basisParas. 1 and 1-1 of Art. 244 of the Code of the RK on Public Health and the Healthcare System

The Code contains a referring provision: breach of the healthcare legislation of the Republic of Kazakhstan entails the liability established by the laws of Kazakhstan. The specific offences and sanctions are set out in the Code of Administrative Offences and the Criminal Code, so the type and extent of liability is determined under those acts for the particular breach.

Legal basisArt. 275 of the Code of the RK on Public Health and the Healthcare System

Yes. Licensing applies to the import into Kazakhstan from states outside the Eurasian Economic Union, and the export to those states, of human organs and parts of organs, tissues and parts of tissues, blood and its components. The procedure for licensing such import and export is set out in a separate article of the Code.

Legal basisSub-para. 4) of para. 1 of Art. 17 and Art. 18 of the Code of the RK on Public Health and the Healthcare System

Advertising of medicines and medical devices follows the procedure determined by the state body in the sphere of circulation of medicines and medical devices. Advertising of products subject to state sanitary and epidemiological control and to state registration follows the procedure determined by the state body for sanitary and epidemiological welfare. Advertising of medical services follows the procedure determined by the state body in the sphere of medical services. The requirements for advertising services, methods and means of prevention, diagnosis, treatment and rehabilitation are set out in paragraph 2 of Article 56.

Legal basisParas. 1 and 2 of Art. 56 of the Code of the RK on Public Health and the Healthcare System

Wholesale sale is carried out by entities that have obtained the corresponding licence for wholesale sale at pharmaceutical warehouses, or that have notified the commencement of activity through a medical device warehouse under the Law on Permits and Notifications. Retail sale is carried out by entities holding the corresponding retail licence for pharmacies, pharmacy points and mobile pharmacy points, or that have notified the commencement of activity through optical and medical device shops. The regime therefore depends on the type of outlet: pharmacies and medicine warehouses need a licence, optical and device shops only a notification.

Legal basisParas. 1 and 2 of Art. 233 of the Code of the RK on Public Health and the Healthcare System

Medicines must be placed into circulation with labelling applied to the primary or secondary packaging in clearly legible type in the Kazakh and Russian languages, and with instructions for medical use — a package leaflet — in Kazakh and Russian. The texts of the labelling and the instructions must comply with the requirements of the Law on Languages. Medical devices must be placed into circulation with labelling applied to the device itself and to the packaging, in the manner set out in the same article.

Legal basisParas. 1 and 3 of Art. 242 of the Code of the RK on Public Health and the Healthcare System

The summary of product characteristics approved on state registration is published for medical workers on the internet resources of the authorised body and of the state expert organisation in the sphere of circulation of medicines and medical devices. This is the official source of information about a product, as distinct from advertising and promotional materials.

Legal basisPara. 2 of Art. 242 of the Code of the RK on Public Health and the Healthcare System

Clinical studies of medicines and medical devices are conducted with human participation to identify or confirm the clinical and pharmacodynamic effects of the product under study, to identify adverse reactions, to study the absorption, distribution, biotransformation and elimination of medicines, and to assess the safety and functional characteristics of medical devices and adverse events involving them, in order to establish safety and efficacy. Clinical laboratory testing of in vitro diagnostic devices covers analytical characteristics and clinical effectiveness.

Legal basisPara. 1 of Art. 238 of the Code of the RK on Public Health and the Healthcare System

The Code devotes a separate article to the liability of digital healthcare entities. It applies to organisations and persons working with medical information systems and electronic medical data, alongside the general rules on liability for breaching healthcare legislation.

Legal basisArts. 61 and 275 of the Code of the RK on Public Health and the Healthcare System

The procedure for financing volumes of medical care is set out in Article 68 of the Code. It applies together with the provisions on the guaranteed volume of free medical care, the principles on which it is formed, the purposes of care provided within it, and the minimum social standards in healthcare.

Legal basisArts. 68, 196, 197, 198 and 199 of the Code of the RK on Public Health and the Healthcare System

Good pharmaceutical practices are approved by order of the authorised body in healthcare. Compliance with them, and with the requirements for introducing, maintaining and assessing the quality management system for medical devices, is checked by the pharmaceutical inspectorate. The scope of the requirements depends on the type of activity and on the potential risk of use of the devices.

Legal basisOrder approving good pharmaceutical practices; para. 1 of Art. 244 of the Code of the RK on Public Health and the Healthcare System

The inspection covers compliance with good pharmaceutical practices for medicines and with the requirements for introducing, maintaining and assessing the quality management system for medical devices, depending on the potential risk of their use. It is carried out by the structural units of the state body in the sphere of circulation of medicines and medical devices, its territorial units and the state expert organisation; inspections by the latter are classified as a state monopoly.

Legal basisParas. 1 and 1-1 of Art. 244 of the Code of the RK on Public Health and the Healthcare System; Order approving good pharmaceutical practices

State control takes the form of preventive control, which is precautionary in nature, inspection and investigation. Preventive control is divided into control without a visit to the entity, control with a visit, and a control purchase. An inspection carried out in gross breach of the requirements for its organisation and conduct is declared invalid, and its report and order cannot serve as evidence of a breach.

Legal basisArt. 137 and para. 1 of Art. 156 of the Entrepreneurial Code of the RK

Officials may not check compliance with requirements that are not in their body's checklists or that fall outside its competence; demand documents, information, product samples and other samples that do not relate to the object and subject matter of the control; or take samples for testing otherwise than in the prescribed manner. The full list of restrictions is in Article 151 of the Entrepreneurial Code.

Legal basisArt. 151 of the Entrepreneurial Code of the RK

The medical organisation, as employer, answers to the patient and compensates the harm. Having done so, it may bring a recourse claim against the employee within the limits set by employment law: the employee compensates the actual direct damage, the limits of restricted liability are fixed by the employment or collective agreement or by an act of the employer, and in the cases expressly listed in the Code liability is full. Criminal liability for improper performance of professional duties is always personal.

Legal basisArts. 123 and 115 of the Labour Code of the RK; Art. 270-1 of the Code of the RK on Public Health and the Healthcare System