Importing medicines into Kazakhstan

The regulator

The Committee for Medical and Pharmaceutical Control (KMFK) of the Ministry of Health issues the conclusions, or permit documents, needed to import medicines that are not registered in Kazakhstan. Its service page confirms that the conclusion is applied for electronically through egov.kz or elicense.kz and issued within 3 working days, under Article 251 of the Code on Public Health and the Healthcare System. The National Center for Expertise of Medicines and Medical Devices (NCELS) carries out expert review for registration.

Kazakhstan is a member of the Eurasian Economic Union (EAEU). National registrations had to move to the common EAEU rules by 31 December 2025, with extensions reported for dossiers already in the alignment procedure, so check the registration status of any product before treating it as registered.

Legal routes for unregistered medicines

The import rules were approved by Order KR DSM-237/2020 and restated by Order 28 of 23 February 2023. They list the cases in which an unregistered medicine may be imported under a conclusion: a specific patient's vital needs or a limited group with rare or particularly severe diseases, emergencies, humanitarian aid, innovative medical technologies, supplies from UN bodies or WHO-prequalified sources to the single distributor, samples for registration, exhibitions and clinical trials. Separate paragraphs cover goods from EAEU states and from other countries, with largely the same documents.

A specific patient or patients with rare diseases

Order KR DSM-280/2020 sets the clinical side. The healthcare organisation's council of doctors must conclude, in line with the clinical protocol, that registered alternatives are ineffective or cannot be used. The patient or a legal representative gives written informed consent, and the organisation then monitors side effects and efficacy. Regional health bodies can file consolidated applications for several patients, based on calculated need.

For the import conclusion, the applicant adds a quantity calculation, a letter from the regional health authority, the contract or invoice and quality documents translated into Kazakh or Russian, the GMP certificate and proof of registration in the country of manufacture. Where a registered analogue exists, letters from its manufacturer saying it cannot be supplied are also needed. The applicant commits to add a sticker and instructions in Kazakh and Russian.

2025 changes

Order 62 of 1 July 2025 confirmed the 3 working day review, limited each conclusion to the calendar year in which it is issued and requires a report on its use within 15 calendar days after it expires. A conclusion issued in November therefore lapses on 31 December. Mybuh.kz reports that the service is free of charge.

Documents a buyer usually needs

• KMFK conclusion for the import, issued to the Kazakh applicant
• Council of doctors conclusion, patient consent and the regional health authority letter
• Quantity calculation
• Contract or invoice and certificate of analysis, translated into Kazakh or Russian
• GMP certificate and proof of registration abroad, such as a certificate of pharmaceutical product
• Commitment letter on the Kazakh and Russian sticker and instructions
• Packing list and air waybill with names and quantities matching the conclusion

Timeline: a worked example

A regional hospital in Kazakhstan needs an unregistered orphan medicine for one child, with a licensed Kazakh distributor acting as importer.

Total: roughly 3 to 7 weeks from request to delivery. These are planning estimates, not published service times.

Shipping lanes from India

Almaty is the main air cargo gateway. IndiGo resumed Almaty and Tashkent flights from Mumbai in September 2025, four times a week each, after a pause linked to airspace closures. Other routings connect through Dubai, Doha, Istanbul or Tashkent. Express courier service for small, non-controlled parcels is usually 4 to 8 days door to door, and air cargo with a customs broker is usually 6 to 14 days including clearance.

CIP and DAP to Almaty are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the Kazakh applicant holds the conclusion and clears the goods.

Practical tips for buyers

• Time the shipment to the calendar year. A conclusion lapses on 31 December, so a late-year approval leaves little time to ship.
• Report on the use of each conclusion within 15 calendar days after it expires, including when nothing was shipped.
• Duty on HS 300490 is 0 percent according to World Bank WITS data for 2023, lower than the 3 percent EAEU rate shown for some medicine lines in Russia, so confirm the current rate with a customs broker.
• VAT on imported medicines is 5 percent from 1 January 2026 and is due to rise to 10 percent from 1 January 2027, according to the state revenue department. Medicines for state-funded free care, compulsory health insurance and orphan and socially significant diseases can be exempt, and Resolution 542 of 24 June 2026 widened the exempt lists.
• Prepare Kazakh and Russian labelling in advance, since the importer commits to it in the application.