Pharmaceutical Licensing in Uzbekistan

Product Registration — State Register

All pharmaceutical products must be registered in Uzbekistan's State Register of Medicines before sale or import. Registration requires full dossier submission including clinical data, manufacturing documentation, and quality control data. Ministry of Health review (Law on Medicines and Pharmaceutical Activity, Art. 12). Since 1 October 2025, medicines registered by a WHO Listed Authority or a regulator at WHO Maturity Level 4 are registered in Uzbekistan by recognition (Presidential Decree No. UP-137 of 19 August 2025). Registration valid for 5 years, renewable. Bond Stone coordinates dossier submission and Ministry liaison.

GMP Certification

Good Manufacturing Practice (GMP) compliance required for manufacturing and import activities. Uzbekistan increasingly aligns with WHO GMP standards. GMP inspection by Ministry of Health for domestic manufacturers; for foreign manufacturers, GMP certificate from recognised authority may be accepted. Bond Stone advises on GMP compliance planning and inspection preparation.

Importing Medicines

The annex to Law No. ZRU-701 lists no separate import licence for registered medicines: state registration is the gateway. Narcotic and psychotropic substances have their own licence. Confirm the customs and quality requirements for each product before shipment.

ASL Belgisi Serialisation — Mandatory

Mandatory track-and-trace serialisation system for all pharmaceutical products. Three-phase rollout completed — local products (2022), imported medicines (2023), approved medicines lists (2025). Companies must obtain Electronic Digital Signature (EDS), register with ASL Belgisi system, and report marking, aggregation, withdrawal, and release events. Non-compliance can block customs clearance and market access.

Distribution & Wholesale Licence

Wholesale and retail sale need a licence from the Agency for Development of the Pharmaceutical Industry or its territorial units. Storage conditions, GDP compliance, and qualified pharmacist requirements apply. Bond Stone advises foreign companies on establishing compliant distribution structures — direct subsidiary, licensed distributor agreements, or third-party logistics arrangements.

Local Manufacturing Licence

Government actively incentivises pharmaceutical manufacturing localisation — import substitution policy, SEZ tax incentives for qualifying manufacturers, and preferential procurement in state healthcare procurement. The manufacturing licence comes from the same Agency and requires GMP compliance and site inspection. Bond Stone advises on manufacturing investment structuring and licensing.