Registration of Medicines and Medical Devices: “One Window” Pilot Project Extended - FCHAIN

Registration of Medicines and Medical Devices: “One Window” Pilot Project Extended

In Kazakhstan, the pilot project for implementing a composite public service for the registration of medicines and medical devices under the “one window” principle has been extended. The corresponding decision is закреплено by a joint order of the Minister of Health of the Republic of Kazakhstan dated March 11, 2026 No. 30 and the Deputy Prime Minister – Minister of Digital Development and Artificial Intelligence dated March 12, 2026 No. 140.

The document entered into force on April 6, 2026, and applies to legal relations arising from January 1, 2026, and will remain in effect until December 31, 2026.

 

What has changed: “One Window” principle

The key element of the pilot project is the implementation of the “one window” principle. This means that:

1. all documents are submitted electronically through a single digital interface;
2. there is no need to interact with multiple government agencies;
3. information systems of authorized bodies are integrated;
4. application review processes become faster and more transparent.

 

Objectives of the pilot project

The project aims to reduce registration timelines for medicines and medical devices, simplify administrative procedures for businesses, increase transparency of regulatory processes, reduce administrative burden on applicants, and develop digital services and electronic interaction between the state and business.

 

Services provided

Through the e-government portal, the Ministry of Health provides a comprehensive service including:

1. expert evaluation;
2. registration and re-registration;
3. amendments to the registration dossier;
4. registration and adjustment of manufacturer prices;
5. formation of the Kazakhstan National Drug Formulary.

 

Service timelines

The total service delivery period does not exceed 100 working days.

This period does not include:

1. time for correcting incomplete dossiers;
2. time for submission of additional documents by the applicant;
3. organization and conduct of inspections;
4. expert council procedures;
5. approval of final documents.

Additionally:

1. the applicant must confirm consent for inspection within 30 working days;
2. inspections may take up to 90 working days.

 

Cost of services

The registration fee is established by the Tax Code of the Republic of Kazakhstan:

• 11 MCI (47,575 KZT in 2026) — for state registration;
• 5 MCI (21,625 KZT) — for re-registration.

Payment can be made in cash or non-cash form through second-tier banks.

 

Approved procedures

The project also approves procedures for service provision, rules for examination and registration of medicines, rules for registration of medical devices, and procedures for forming the National Drug Formulary.

 

Conclusion

The extension of the pilot project until the end of 2026 confirms Kazakhstan’s course toward digitalization and simplification of business interaction with the government. The “one window” principle significantly reduces administrative barriers and accelerates market entry.

 

FChain Accounting and Tax Services

FChain provides professional accounting and tax services for businesses in Kazakhstan:

1. accounting and tax bookkeeping;
2. services for pharmaceutical and medical companies;
3. timely preparation and submission of reports;
4. consulting on the application of new regulations.

Contact us to ensure reliable financial and tax support for your business.

 

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Prepared by: Moldir Mukhtar

Business Development Specialist

FChain Kazakhstan

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