Pharmaceutical licensing — Ministry of Healthcare

Pharmaceutical licensing in Kazakhstan is administered by the Committee for Medical and Pharmaceutical Control under the Ministry of Healthcare. Licensed activities include: pharmaceutical manufacturing; wholesale distribution of pharmaceutical products; retail distribution (pharmacy operations); import and export of pharmaceutical products; and medical device manufacturing and distribution. Each licence category requires compliance with Good Manufacturing Practice (GMP) standards, qualified pharmacist personnel, facility certification, and product registration.

Product registration — prerequisite to import

Before pharmaceutical products can be imported into Kazakhstan, they must be registered with the Committee for Medical and Pharmaceutical Control. Product registration requires submission of clinical data, quality documentation, manufacturing site information, and labelling compliance. Registration typically takes 6–12 months. Bond Stone coordinates pharmaceutical product registration as part of market entry advisory — advising on registration strategy, documentation requirements, and accelerated registration pathways for products already registered in EAEU member states.

EAEU harmonisation — Common Pharmaceutical Market

Kazakhstan is a member of the Eurasian Economic Union (EAEU). The EAEU Common Pharmaceutical Market framework provides for mutual recognition of pharmaceutical product registrations across EAEU member states — Russia, Kazakhstan, Belarus, Kyrgyzstan, and Armenia. Products registered under the EAEU Common Market framework can be imported across member states without re-registration. Bond Stone advises on EAEU pharmaceutical market entry strategies that leverage Common Market registration.

GMP compliance — manufacturing licences

Pharmaceutical manufacturing licences in Kazakhstan require GMP compliance certification — either Kazakhstan national GMP certification or recognition of international GMP certificates (EU-GMP, WHO-GMP, PIC/S). Bond Stone advises on structuring GMP certification documentation for the Committee for Medical and Pharmaceutical Control and coordinates with GMP inspection processes for foreign manufacturers seeking Kazakhstan manufacturing licences or import authorisation.

Pharma Import & Wholesale Licence

Licensing · Kazakhstan · Pharma

Obtaining pharmaceutical import and wholesale distribution licences for an international pharmaceutical company — product registration coordination, GMP compliance documentation, qualified pharmacist requirements, and Ministry of Healthcare liaison.

Medical Device Registration

Licensing · Kazakhstan · Healthcare

Registering Class II and Class III medical devices with the Committee for Medical and Pharmaceutical Control — technical documentation, clinical evaluation report, labelling compliance, and post-market surveillance plan preparation.

EAEU Market Entry — Registration Strategy

Licensing · Kazakhstan · EAEU

Advising a European pharmaceutical company on EAEU Common Pharmaceutical Market entry strategy — choosing between Kazakhstan national registration and EAEU Common Market registration, and structuring the registration timeline across priority EAEU markets.