HEALTHCARE AND PHARMACEUTICALS

Medical activity is subject to mandatory licensing by sub-type, covering the types of medical care and the specialisms concerned. The application is filed electronically through the e-licensing portal and signed with an electronic digital signature; the licence is issued for an unlimited term and is valid throughout the Republic of Kazakhstan. The applicant must meet the qualification requirements: premises complying with the sanitary rules, the necessary equipment, and specialists holding valid certificates.

Legal basisCode of the RK on Public Health and the Healthcare System; Law of the RK on Permits and Notifications

Accreditation is an assessment of a healthcare entity against accreditation standards, confirming the level of quality and safety of its services. Accreditation is voluntary in itself, but it is a condition for participating in the guaranteed volume of free medical care and in care provided under compulsory social health insurance, and it affects admission to certain activities. It is carried out by authorised accreditation bodies on the organisation's application.

Legal basisCode of the RK on Public Health and the Healthcare System (accreditation provisions)

A specialist must hold relevant medical education, a specialist certificate in the corresponding speciality, and must maintain their qualification through continuing professional development. The certificate is issued following an assessment of knowledge and skills and must be periodically confirmed. Practising without a valid certificate breaches the licensing requirements and gives rise to liability for both the individual and the medical organisation.

Legal basisCode of the RK on Public Health and the Healthcare System (provisions on medical workers and admission to clinical practice)

Informed consent is required before any medical intervention; written form is mandatory for invasive interventions, surgical procedures, methods carrying an increased risk and in the other cases established by the authorised body. The patient must be given accessible information about the nature of the intervention, the risks, the alternatives and the consequences of refusal. Absence of properly documented consent is a typical basis on which patient claims succeed, even where the treatment itself was technically faultless.

Legal basisCode of the RK on Public Health and the Healthcare System (provisions on informed consent and refusal of care)

Information about the fact of seeking care, the diagnosis, the state of health and other data obtained in the course of treatment constitutes medical confidentiality. Disclosure without the patient's consent is permitted only in the cases expressly listed in law: on request of the inquiry, investigation, prosecution or judicial authorities in connection with proceedings; where there is a threat of the spread of infectious disease; where harm is suspected to have been inflicted by violence; and to provide care to a person unable to express their will. Unlawful disclosure entails disciplinary, administrative and criminal liability.

Legal basisCode of the RK on Public Health and the Healthcare System; Art. 321 of the Criminal Code of the RK

A patient is entitled to information about their state of health and the proposed treatment, to choose a medical organisation and a doctor (within the limits of their attachment), to obtain an independent second opinion, to examine their medical records and receive copies, to refuse a medical intervention, to challenge the actions of medical workers and to claim compensation for harm. These rights cannot be limited by the organisation's internal rules.

Legal basisCode of the RK on Public Health and the Healthcare System (chapter on patients' rights and obligations)

Civil liability arises under the general rules on compensation for harm: the organisation is liable for the acts of its employees and must compensate pecuniary loss and non-pecuniary damage. The medical organisation's fault is presumed, and it bears the burden of proving the absence of fault; the decisive evidence is a forensic medical report establishing defects in the care provided and a causal link with the consequences. Criminal liability of the individual medical worker for improper performance of professional duties may arise in parallel.

Legal basisArts. 917, 921, 923, 951–952 of the Civil Code of the RK; Art. 317 of the Criminal Code of the RK

Quality is assessed through internal expert review by the organisation itself, external (state) review by the authorised body for medical and pharmaceutical control, and independent expert review. In court proceedings the decisive evidence is a forensic medical examination ordered by the court. Practice shows that a timely internal case review and properly maintained medical records materially reduce the organisation's exposure.

Legal basisCode of the RK on Public Health and the Healthcare System; Arts. 66, 91 of the Civil Procedure Code of the RK

Employers pay deductions for their employees, employees pay contributions withheld from their income, and individual entrepreneurs and persons working under civil law contracts pay contributions for themselves, while the state pays for certain exempt categories. The rates are set by the Law on Compulsory Social Health Insurance and are being introduced in stages, so the current percentage should be verified as at the date of calculation. Non-payment results in late-payment interest, administrative liability and loss of insured status for the employee.

Legal basisLaw of the RK on Compulsory Social Health Insurance; Tax Code of the RK (2025, No. 214-VIII)

The guaranteed volume of free medical care is available to all citizens, kandas and certain categories of foreign nationals regardless of insured status, and covers emergency care, care for socially significant diseases and in emergency situations, and preventive measures. The insurance package is available only to insured persons and covers a wider range: consultative and diagnostic care, planned inpatient and day-patient care, and medicines for certain conditions. The lists are approved by Government resolution and are periodically revised.

Legal basisCode of the RK on Public Health and the Healthcare System; Law of the RK on Compulsory Social Health Insurance

Registration is carried out under the rules of the Eurasian Economic Union or, where transitional provisions so allow, under the national procedure. The applicant files a registration dossier in CTD format with the expert organisation, which assesses quality, safety and efficacy and, where necessary, inspects the manufacturing site; on completion a marketing authorisation is granted and an entry is made in the register. The authorisation has a limited term and must subsequently be confirmed.

Legal basisCode of the RK on Public Health and the Healthcare System; Decision of the EEC Council No. 78 of 3 November 2016

Medical devices are registered by reference to their potential risk class: the higher the class, the wider the range of required testing — technical, toxicological and clinical-laboratory — and the more demanding the requirements for the manufacturer's quality management system. Both the EAEU procedure, with recognition across member states, and the national procedure in the prescribed cases are available. Placing an unregistered device on the market is prohibited and entails administrative liability and seizure of the products.

Legal basisCode of the RK on Public Health and the Healthcare System; EEC acts on the circulation of medical devices

Licensing covers the manufacture of medicinal products, the compounding of medicines, and the wholesale and retail sale of medicines and medical devices. Each sub-type carries qualification requirements as to premises and equipment, storage conditions, quality systems and personnel with pharmaceutical education. Confirmation of compliance with good practices (GMP, GDP, GPP) is additionally required in the prescribed cases.

Legal basisLaw of the RK on Permits and Notifications; Code of the RK on Public Health and the Healthcare System

These are standards of manufacturing, distribution and pharmacy practice, compliance with which is confirmed by a certificate issued following inspection. A GMP certificate is required of domestic manufacturers and is generally a condition for registering a foreign manufacturer's product; GDP applies to distributors and GPP to pharmacies. Non-compliance is a ground for refusing registration, suspending a licence and recalling products from the market.

Legal basisCode of the RK on Public Health and the Healthcare System; acts of the authorised body and of the EEC

Advertising of prescription medicines to the general public is prohibited and is permitted only in specialised publications and at events for medical and pharmaceutical professionals. Advertising of over-the-counter medicines is permitted where the product is registered in Kazakhstan and after approval has been obtained in the prescribed manner, and must carry a warning to consult a specialist. Advertising featuring medical professionals as endorsers, references to individual cases of recovery and guarantees of effect are prohibited.

Legal basisCode of the RK on Public Health and the Healthcare System; Law of the RK on Advertising

Medicines purchased within the guaranteed volume of free medical care and the insurance system, and products included in the established lists, are subject to state price regulation: maximum manufacturer prices and wholesale and retail mark-ups are approved. Selling above the maximum price is prohibited and entails administrative liability with confiscation of the unlawfully obtained income. Organisations should therefore reconcile their price lists regularly against the current orders of the authorised body.

Legal basisCode of the RK on Public Health and the Healthcare System; Art. 425 of the Code of Administrative Offences of the RK

Retail sale of medicines by distance selling is permitted for entities holding a retail licence, subject to compliance with storage and transport conditions, identification of the purchaser and proper documentation. Restrictions apply to certain categories, in particular narcotic and psychotropic substances, precursors and certain prescription products. Sales of medicines by persons without a licence, including through social media and marketplaces, are unlawful.

Legal basisCode of the RK on Public Health and the Healthcare System; rules on the retail sale of medicinal products

Activities involving their circulation require a separate licence, compliance with the storage regime (reinforced premises, alarm systems), subject-quantitative accounting, maintenance of special registers and destruction by commission with a formal record. Transport and dispensing are carried out using the prescribed forms of prescription and delivery note. Breach of the rules of circulation entails administrative and criminal liability irrespective of whether any loss was caused.

Legal basisLaw of the RK on Narcotic Drugs, Psychotropic Substances, their Analogues and Precursors; Arts. 297, 322 of the Code of Administrative Offences of the RK; Art. 296 of the Criminal Code of the RK

The holder must operate a pharmacovigilance system, appoint a qualified person, maintain a pharmacovigilance system master file, collect and submit reports of adverse reactions within the prescribed periods, submit periodic safety update reports and take risk minimisation measures. Failure to comply is a ground for suspending or withdrawing the marketing authorisation.

Legal basisCode of the RK on Public Health and the Healthcare System; pharmacovigilance rules (EAEU and national)

A positive opinion of the local or central ethics committee is required, together with authorisation from the authorised body, an agreement with the investigational site, insurance of the life and health of trial participants, and written informed consent from each participant. The trial is conducted in accordance with the protocol and with good clinical practice (GCP). Breach of the procedure renders the results invalid and exposes the sponsor and the investigator to liability.

Legal basisCode of the RK on Public Health and the Healthcare System (chapter on clinical trials); GCP rules

Telemedicine is treated as a form of delivering medical care using information and communication technologies and may be provided by healthcare entities licensed for the relevant types of care. Identification of the patient, recording of the consultation in the medical information system and compliance with personal data protection and medical confidentiality requirements are all required. Types of care requiring an in-person examination are not delivered remotely, nor may a diagnosis be made where the rules expressly prohibit it.

Legal basisCode of the RK on Public Health and the Healthcare System; rules on the remote provision of medical services

Medical records are maintained electronically in medical information systems integrated with the healthcare information systems, while personal data protection requirements are observed. Retention periods vary by document type and are established by the schedule of documents with retention periods; the standard forms are approved by the authorised body. Loss or incompleteness of records is generally assessed against the medical organisation in a dispute with a patient.

Legal basisCode of the RK on Public Health and the Healthcare System; Law of the RK on the National Archive Fund and Archives

The contract must define its subject matter (the list and scope of services), the price and payment arrangements, the timeframes, the parties' rights and obligations, the arrangements for informing the patient, liability, and the dispute resolution procedure. The price list must be annexed and informed consent must be documented separately. Terms limiting the medical organisation's liability below the statutory level or depriving the patient of consumer rights are void.

Legal basisCode of the RK on Public Health and the Healthcare System; Law of the RK on Consumer Rights Protection; Ch. 33 of the Civil Code of the RK

Yes, refusal of a medical intervention must be documented in writing, setting out the possible consequences explained to the patient or their statutory representative, and signed by both the patient and the medical worker. Where a statutory representative's refusal threatens the life or health of a minor or a legally incapable person, the medical organisation must apply to the guardianship authority or the court. An undocumented refusal offers the organisation no real protection in a dispute.

Legal basisCode of the RK on Public Health and the Healthcare System

Importation is carried out by entities holding a pharmaceutical licence (or, in the prescribed cases, by manufacturers and medical organisations), on the basis of an authorisation document issued by the authorised body and confirmation that the products are registered. Unregistered products may be imported only for limited purposes: clinical trials, registration, treatment of a named patient on vital indications, and humanitarian aid. EAEU customs procedures and technical regulation requirements apply in addition.

Legal basisCode of the RK on Public Health and the Healthcare System; Customs Code of the EAEU; EEC decisions

Mandatory preliminary (on hiring) and periodic medical examinations apply to employees engaged in heavy work and work in harmful and hazardous conditions, and to employees in certain sectors — food production, food retail, education, healthcare and transport. Arranging and paying for the examinations is the employer's responsibility, and employees who have not undergone them must be suspended from work. Failure to comply entails administrative liability for the employer.

Legal basisCode of the RK on Public Health and the Healthcare System; Art. 185 of the Labour Code of the RK; Art. 425 of the Code of Administrative Offences of the RK

Medical waste must be segregated by hazard class, collected in marked containers, stored temporarily in designated premises and transferred under contract to specialist organisations for neutralisation or disposal. The organisation must have written procedures, appoint responsible persons and keep records. Breach of the sanitary and epidemiological requirements in this area is one of the findings most frequently identified during inspections.

Legal basisEnvironmental Code of the RK; sanitary rules on the handling of medical waste

The Code of Administrative Offences provides for liability for breaches of healthcare legislation, sale of unregistered or falsified medicines and medical devices, breach of storage and sale requirements, breach of the pricing rules, operating without a licence and breach of licensing requirements, and breach of sanitary and epidemiological requirements. Sanctions include fines, confiscation of products and suspension of operations, with amounts increasing substantially on repeat offences.

Legal basisArts. 80, 425, 426, 463 of the Code of Administrative Offences of the RK

The medical organisation, as employer, is liable to the patient; having compensated the harm, it may bring a recourse claim against the employee within the limits set by employment law — as a general rule up to the employee's average monthly wage, or in full where full financial liability applies. Criminal liability for improper performance of professional duties is always personal. Professional indemnity insurance reduces the financial burden on both sides.

Legal basisArts. 921, 933 of the Civil Code of the RK; Arts. 123, 124 of the Labour Code of the RK; Art. 317 of the Criminal Code of the RK

Health data is personal data of restricted access: its collection and processing are permitted with the data subject's consent or in the cases expressly provided for by law. The operator must implement protective measures, define the list of data collected, appoint a responsible person and store databases within the Republic of Kazakhstan. Unlawful collection and dissemination of such information entails administrative and criminal liability.

Legal basisLaw of the RK on Personal Data and its Protection; Art. 79 of the Code of Administrative Offences of the RK; Art. 147 of the Criminal Code of the RK