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Legal News – August 2026 - FCHAIN

Legal News – August 2026

 August 2026 brought new requirements in the areas of circulation of medicines and medical devices, digitalization of healthcare, labor relations, education, as well as export and import procedures. For businesses and employers, these changes mean the need to review certain internal processes, documents and digital procedures, while individuals should take the updated rules into account when interacting with organizations and government systems. Let us consider the most important changes of August.

 

The procedure for registration of medicines and medical devices is changing

State registration and re-registration of medicines and medical devices, as well as amendments to the registration dossier, are now directly linked to mandatory expert examination in accordance with the legislation of the Republic of Kazakhstan. Applications for expert examination, state registration or re-registration, amendments to the registration dossier, as well as registration or amendment of the manufacturer’s price are submitted by the applicant, manufacturer or their authorized representatives as part of a composite service. An expedited expert examination procedure is provided for medicines, in particular, in the following cases:

  1. a joint medicine registration procedure with the WHO;
  2. a WHO medicine requalification procedure;
  3. registration of a medicine by regulatory authorities with a stringent regulatory system as determined by the WHO;
  4. other cases provided for by the legislation of the Republic of Kazakhstan.

Expedited expert examination of medical devices applies, in particular, to devices that have certificates from regulatory authorities of the European Commission in the European Union (CE marking), regulators that are members of the Management Committee of the International Medical Device Regulators Forum (IMDRF), as well as devices requalified by the WHO. At the same time, the expedited procedure does not mean reduced requirements: the safety, quality and effectiveness of medicines and medical devices must be confirmed in full.

 

State price regulation in the area of medicine supply has been clarified

State price regulation applies to certain categories of medicines and medical devices. In particular, the following are subject to regulation:

  1. medicines for wholesale and retail sale included in the list of medicines subject to price regulation;
  2. medicines and medical products purchased within the guaranteed volume of free medical care and/or the mandatory social health insurance system;
  3. in vitro diagnostic medical devices manufactured in Kazakhstan under long-term supply agreements with the single distributor.

The list of medicines subject to price regulation for wholesale and retail sale is approved by the authorized body. The same body approves manufacturer prices and maximum prices for trade names of medicines included in the relevant list.

 

The Ministry of Healthcare updated the minimum requirements for medical digital systems

The updated requirements apply to medical digital systems of healthcare entities regardless of their form of ownership. A medical digital system must ensure the transfer of clinical and administrative data arising in the provision of medical care, including information on medical events and electronic documents certified by an employee’s digital signature. When government systems are ready to receive data, such transfer must be carried out within a period not exceeding three working days. A separate requirement has been established for primary healthcare organizations: schedules of appointments with doctors and specialized professionals must be transmitted to the digital systems of the authorized body in real time. Healthcare entities seeking to provide care within the guaranteed volume of free medical care and the mandatory social health insurance system must ensure technological measures for identifying patients or their legal representatives through digital confirmation or multifactor digital authentication. Medical digital systems are also used to account for the consumption and write-off of medicines. A separate set of requirements concerns the protection of patients’ personal data.

 

Labor legislation: new guarantees for employees and obligations for employers

From 4 August, amendments aimed at improving labor legislation come into effect. The amendments strengthen employee guarantees and clarify employer obligations. The main changes include:

  1. employees are granted the right to privacy, respect, and protection of their honor and dignity in the workplace;
  2. at the request of pregnant women, persons with children under the age of three, minors and persons with disabilities, the employer is required to provide in writing the reason for refusal to conclude an employment contract;
  3. the employer is required to notify the employee in writing of changes to working conditions;
  4. the procedure for terminating employment relations with materially responsible employees, as well as the transfer and acceptance of property and documents, is clarified;
  5. the employer is required to ensure that facilities and work equipment used in the production process comply with safety requirements;
  6. state labor inspectors are required to regularly improve their qualifications in the field of occupational safety and health;
  7. the legal status of the technical occupational safety inspector has been defined.

For employers, this means the need to review notification forms, HR procedures, local acts and occupational safety documents for compliance with the new requirements.

 

From 4 August, the risk assessment criteria in the field of labor legislation are changing

The changes affect the procedure for assigning employers to risk categories during state control over compliance with labor legislation. Under the objective criteria, high-risk entities include, in particular, controlled entities employing more than 30 foreign workers according to data from the automated digital system “Foreign Labor Force” of the Ministry of Labor and Social Protection of the Population of the Republic of Kazakhstan. When assessing the degree of risk, adverse incidents are taken into account, including serious, group and fatal occupational accidents, the results of reporting monitoring, as well as the results of previous inspections and preventive control with visits. The risk assessment and management system must use digital systems, state statistics, the results of departmental statistical observation and other information tools. The list of violations has also been supplemented with new items. Ensuring the completeness and timeliness of professional payments at the employer’s expense is classified as a gross violation, while the existence of a pre-retirement annuity agreement is classified as a significant violation.

 

Education: responsibility of teachers, mobile phones and medical education

From 13 August, changes in the field of education come into effect. Among the most notable innovations is clarification of the period during which teachers and school administrators are responsible for students: such responsibility is linked to working hours. The Ministry of Education is empowered to develop and approve rules for students’ use of mobile phones. A prohibition is also introduced on teachers simultaneously maintaining the same reporting in paper and electronic formats, which should reduce duplication of administrative workload. Separate amendments create conditions for the operation of leading foreign universities in Kazakhstan. Branches may be opened provided that the requirements of the state compulsory education standards of the Republic of Kazakhstan are met. In higher medical education, a transition to an integrated medical education model is envisaged: six years of university study and one full year of internship. Upon completion, graduates receive the right to begin medical practice, while the internship effectively becomes a stage of clinical training.

 

Import and export: licensing becomes more automated

The Rules for issuing licenses for the export and import of certain types of goods when quantitative restrictions (quotas) are introduced have been amended. The state digital system of permits and notifications fully automatically processes documents and generates the result of the public service — a license for the export of certain types of goods — within one working day from the moment the documents are submitted, without the participation of the service provider. The result is signed with a transport signature. Information on the stage of public service delivery is automatically transferred to the digital system for monitoring public service delivery. For participants in foreign economic activity, this means a further reduction in manual procedures; however, the accuracy of the data and documents submitted becomes especially important: automation does not remove the requirements for their content and compliance with the established rules.

 

FChain — comprehensive legal support for your business

Legislative changes require not only monitoring, but also proper implementation of new requirements in a company’s daily operations. Errors in HR documents, contracts, registration procedures, interaction with government authorities or the organization of internal processes may lead to inspections, disputes, financial losses and administrative liability. The FChain team helps businesses adapt to legislative changes in a timely manner and reduce legal risks. We offer:

FChain is your reliable partner in legal and corporate support matters. We help build processes so that new legislative requirements do not become an obstacle to business development. Contact us — FChain specialists will analyze your situation and offer a practical solution tailored to your company’s objectives and specifics.

 

VAT on Medicines in Kazakhstan

Prepared by: Moldir Mukhtar

Business Development Specialist

FChain Kazakhstan

  📩almaty@f-chain.com
WhatsApp: +7 771 214 1820

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