Pharmaceuticals & Healthcare in Central Asia

Pharmaceutical Registration & Market Access

Medicinal products must be registered before being placed on the market in each Central Asian jurisdiction. In Kazakhstan, state registration is carried out by the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare, after expert evaluation by the National Centre for Expertise of Medicines and Medical Devices. Kazakhstan and Kyrgyzstan are both members of the Eurasian Economic Union (EAEU). Its common market for medicines rests on the Agreement on Common Principles and Rules for the Circulation of Medicines of 23 December 2014 and the registration rules in Eurasian Economic Commission (EEC) Council Decision No. 78 of 3 November 2016. An applicant registers a product in a reference state and can then register it, through mutual recognition, in the other member states it selects. Medicines registered under national rules had to be brought into line with EAEU requirements by 31 December 2025, and national certificates continue for a limited period where an alignment application was filed by that date (EEC Council Decision No. 34 of 22 May 2025). The EEC Council has also extended temporary national registration procedures to 31 December 2027. In Kyrgyzstan the national regulator is the Department of Medicines and Medical Devices under the Ministry of Health. Uzbekistan is outside the EAEU and operates its own national registration system under its Ministry of Health.

Bond Stone assists pharmaceutical companies in navigating registration procedures, preparing localised regulatory documentation, engaging with state agencies on registration timelines, and structuring market access arrangements, including exclusive distribution rights and local representative agreements.

Distribution Agreements & Commercial Structures

International pharmaceutical companies typically access Central Asian markets through local distributor or commercial representative arrangements, as wholesale and retail sale of medicines require local licences. In Kazakhstan the Code on Public Health and the Healthcare System (No. 360-VI of 7 July 2020) and the Law on Permits and Notifications No. 202-V (Annex 1, item 16) set the framework for those licences. Distribution agreements with Kazakhstani or Uzbek partners require careful structuring to address exclusivity, state price regulation of medicines, anti-bribery and anti-corruption compliance under local law and FCPA/UK Bribery Act obligations, and termination and intellectual property protection provisions.

Bond Stone drafts and reviews distribution, agency, and local representative agreements, advises on anti-corruption compliance frameworks for pharmaceutical distribution, and assists with licence transfer or assignment in connection with changes of distributor.

Pharmaceutical Manufacturing & Joint Ventures

Kazakhstan's government has prioritised domestic pharmaceutical manufacturing as a strategic policy objective, and investors in GMP-compliant production may be able to use state procurement arrangements, tax incentives and Special Economic Zone benefits. Joint ventures with Kazakhstani partners are one structuring approach, and supply to public programmes runs through SK-Pharmacy LLP, the state single distributor. Technology transfer agreements, intellectual property licensing, and Good Manufacturing Practice (GMP) certification coordination are key legal components of such arrangements. In Uzbekistan, pharmaceutical manufacturing investment in designated free economic zones offers similar incentive packages.

Bond Stone advises on JV structuring for pharmaceutical manufacturing investments, technology transfer and IP licensing agreements, GMP certification coordination, and state procurement framework compliance for locally manufactured products.

Private Healthcare Investment & Hospital Development

Kazakhstan's Compulsory Social Health Insurance (CSHI) system — in operation since 1 January 2020 — has created a dual public-private healthcare market where private clinics and hospitals can enter into performance-based contracts with the Social Health Insurance Fund, enabling internationally run facilities to compete for publicly funded patients. International hospital groups, private equity investors, and sovereign wealth funds have identified Kazakhstan and Uzbekistan as attractive markets for private hospital development, specialist clinic chains, and diagnostic imaging networks. Tashkent in particular has seen significant private hospital investment following Uzbekistan's healthcare sector reforms beginning in 2019.

Bond Stone advises private healthcare investors on facility licensing requirements, contracting with the Social Health Insurance Fund and voluntary healthcare accreditation, investment structuring through AIFC or Kazakhstani SPVs, land and premises arrangements, and regulatory compliance for international medical staff employment.

Medical Devices & Healthcare Technology

Medical devices are regulated separately from pharmaceuticals in Kazakhstan and Uzbekistan, with registration and import requirements administered by the Ministry of Healthcare (Kazakhstan) and the Ministry of Health (Uzbekistan). Within the EAEU, medical devices are governed by the Agreement on Common Principles and Rules for the Circulation of Medical Devices of 23 December 2014 and the registration and expert evaluation rules in EEC Council Decision No. 46 of 12 February 2016. A protocol signed on 29 December 2025 extended the transition period, so applications under national rules remain possible until 31 December 2027 alongside EAEU registration. Medical technology companies — including diagnostic equipment manufacturers, surgical technology suppliers, and health IT providers — must navigate both product registration and customs import procedures. Telemedicine and digital health platforms are subject to emerging regulatory frameworks in Kazakhstan under the 2020 Code on Public Health and the Healthcare System.

Bond Stone advises medical device companies on compliance with the EAEU medical device rules, Kazakhstani and Uzbek medical device registration, customs classification and import requirements, and commercial distribution agreement structuring.

International Drug Manufacturer — Kazakhstan Registration Strategy
Advised a European pharmaceutical company on the registration of its product portfolio in Kazakhstan, covering Ministry of Healthcare registration dossier requirements, local authorised representative appointment, GMP certification alignment with EAEU requirements, and state procurement eligibility documentation for single distributor-listed medicines.

Pharmaceutical Distribution Network — Central Asia Market Entry
Advised an international pharmaceutical group on establishing a multi-country distribution network across Kazakhstan, Uzbekistan, and Kyrgyzstan, including distributor agreement structuring, regulatory compliance obligations by jurisdiction, anti-corruption clause requirements for government-linked distributor counterparties, and transfer pricing documentation strategy.

Private Hospital Investment — Almaty, AIFC Holding Structure
Advised a private equity-backed healthcare investor on the acquisition and development of a private hospital project in Almaty, including SPV structuring, investment contract negotiations with the Ministry of Healthcare, Social Health Insurance Fund accreditation pathway advisory, and establishment of an AIFC-domiciled holding vehicle with AIFC Court dispute resolution provisions.

Medical Device Licensing — Uzbekistan Market Entry
Advised a South Korean medical device manufacturer on market entry into Uzbekistan, covering state registration requirements for medical devices with the Agency for Sanitary and Epidemiological Well-being, local authorised representative obligations, customs tariff classification, and distributor agreement structuring under Uzbek law.

Pharma Manufacturing JV — Kazakhstan Localisation, EAEU Framework
Advised a multinational pharmaceutical company on establishing a local manufacturing joint venture in Kazakhstan to satisfy import substitution and localisation requirements, covering JV documentation, manufacturing licence under Kazakhstani law, technology transfer agreement structuring, and investment incentive eligibility under the Entrepreneurial Code of Kazakhstan.

How do foreign pharmaceutical companies register drugs in Kazakhstan?

Pharmaceutical products must be registered before market entry. State registration is carried out by the Committee for Medical and Pharmaceutical Control of Kazakhstan's Ministry of Healthcare, after expert evaluation by the National Centre for Expertise of Medicines and Medical Devices. Registration requires a complete dossier including clinical data, manufacturing quality documentation, and evidence of GMP compliance. As a member of the EAEU Unified Pharmaceutical Market, Kazakhstan allows EAEU mutual recognition for products registered under the harmonised procedure.

What is the EAEU Unified Pharmaceutical Market and how does it affect drug registration in Kazakhstan?

The EAEU Unified Pharmaceutical Market harmonises drug registration across Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan. Under EEC Council Decision No. 78 of 3 November 2016, a product registered in a reference state can be registered in the other member states the applicant selects through the mutual recognition procedure, on the basis of the reference state's expert report. Evidence of GMP compliance forms part of the dossier (see the next question).

What distribution structure does a foreign pharma company need to sell in Kazakhstan?

Wholesale and retail sale of medicines need a pharmaceutical licence, and commercial import is limited to licensed or notified businesses. A foreign legal entity may hold a licence directly only if it meets the premises and staffing tests in Kazakhstan, so a foreign group usually works through a local subsidiary or a licensed distributor. Distribution agreements should address exclusivity, state price regulation of medicines, anti-corruption compliance (FCPA/UK Bribery Act) for dealings with state-linked counterparties, and IP protection.

What GMP certification is required for pharmaceutical manufacturers supplying Kazakhstan?

Under EEC Council Decision No. 78, the registration dossier must include a valid document confirming that the manufacturing site complies with EAEU GMP, or a valid national GMP document issued by a member state's authority. If there is no such document, the applicant submits the site's GMP documents from the country of manufacture with inspection reports and related materials, and the reference state decides whether to schedule an inspection. There is no EAEU manufacturing licence: under Article 9 of the EAEU Agreement a manufacturing licence is issued under national law, and in Kazakhstan manufacture requires a licence obtained under Kazakhstani law and compliance with Kazakhstani or EAEU GMP (Article 231 of the Code on Public Health and the Healthcare System).

How can foreign investors structure a private hospital investment in Kazakhstan?

Foreign investors may develop and operate private hospitals in Kazakhstan through a locally incorporated limited liability partnership (LLP) or joint stock company (JSC) holding a medical activity licence (Code on Public Health and the Healthcare System No. 360-VI, Art. 17(1); Law on Permits and Notifications, Annex 1, item 15). Publicly funded care, including care under the Compulsory Social Health Insurance (CSHI) system, is bought by the Social Health Insurance Fund, which keeps a database of healthcare providers seeking to provide it. Accreditation in healthcare is voluntary, but accredited organisations have a preferential right to those contracts (Code No. 360-VI, Arts. 25(4), 69(4), (4-1), (6)). Cross-border holding structures typically use an AIFC SPV or Kazakhstani JSC as the investment vehicle, with AIFC Court dispute resolution.

Why Bond Stone for Pharmaceuticals & Healthcare

• In-country offices in Almaty, Astana, Tashkent, and Bishkek, working directly with healthcare regulators and licensing authorities in all core markets
• Experience structuring pharmaceutical distribution networks and advising international companies on anti-corruption compliance requirements applicable to healthcare sector dealings with government-linked counterparties
• Understanding of the EAEU Unified Pharmaceutical Market and the mutual recognition framework for drug registration across Kazakhstan and other EAEU member states
• Track record advising private healthcare investors on hospital project structuring in Kazakhstan and Uzbekistan, including Social Health Insurance Fund accreditation and local regulatory compliance
• Bond Stone's partners hold AIFC Legal Adviser status and advise on cross-border holding structures, enabling international healthcare groups to use AIFC SPVs with AIFC Court dispute resolution for regional investment platforms
• Trilingual capability (English, Russian, Kazakh) for regulatory filings, Ministry of Health submissions, and commercial negotiations
• Ranked by Legal 500 EMEA and IFLR1000 for corporate and regulatory practice across the region

Entering the Central Asian Pharmaceuticals or Healthcare Market?

Bond Stone provides legal advisory on pharmaceutical registration, distribution structuring, manufacturing joint ventures, private healthcare investment, and medical device licensing across Kazakhstan, Uzbekistan, and Kyrgyzstan.