REGULATORY LICENSING \u00a0\u00b7\u00a0 PHARMACEUTICALS \u00a0\u00b7\u00a0 UZBEKISTAN<\/p>\n
Uzbekistan’s pharmaceutical market reached USD 508 million in projected 2025 revenue, growing at 3.59% CAGR through 2029. Local production accounts for approximately 65% of the market \u2014 but the country remains reliant on imports for essential and innovative medicines, creating significant opportunity for foreign pharmaceutical companies. The Ministry of Health administers product registration, GMP certification, and import licensing. ASL Belgisi mandatory serialisation is fully operational across all product categories as of 2025. Bond Stone has advised multiple international pharmaceutical companies on Uzbekistan regulatory entry \u2014 product registration, import licensing, GMP compliance, and ASL Belgisi serialisation.<\/p>\n
Product Registration \u2014 State Register<\/p>\n
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. Registration valid for 5 years, renewable. Bond Stone coordinates dossier submission and Ministry liaison.<\/p>\n<\/div>\n
GMP Certification<\/p>\n
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.<\/p>\n<\/div>\n
Import\/Export Licence<\/p>\n
Import licence required for pharmaceutical products \u2014 issued by Ministry of Health. Each shipment requires import permit linked to State Register entry. Customs clearance involves phytosanitary and quality control checks. Bond Stone manages import licence applications and coordinates customs compliance for ongoing shipments.<\/p>\n<\/div>\n
ASL Belgisi Serialisation \u2014 Mandatory<\/p>\n
Mandatory track-and-trace serialisation system for all pharmaceutical products. Three-phase rollout completed \u2014 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 results in customs rejection and market access suspension.<\/p>\n<\/div>\n
Distribution & Wholesale Licence<\/p>\n
Pharmaceutical wholesale and retail distribution requires separate Ministry of Health licence. Storage conditions, GDP compliance, and qualified pharmacist requirements apply. Bond Stone advises foreign companies on establishing compliant distribution structures \u2014 direct subsidiary, licensed distributor agreements, or third-party logistics arrangements.<\/p>\n<\/div>\n
Local Manufacturing Licence<\/p>\n
Government actively incentivises pharmaceutical manufacturing localisation \u2014 import substitution policy, SEZ tax incentives for qualifying manufacturers, and preferential procurement in state healthcare procurement. Full manufacturing licence requires GMP compliance, site inspection, and capital investment. Bond Stone advises on manufacturing investment structuring and licensing.<\/p>\n<\/div>\n<\/div>\n
International Pharma Company \u2014 Multi-Product Registration<\/p>\n
Pharma \u00b7 Import Licensing \u00b7 Ministry of Health \u00b7 Ongoing<\/p>\n
Long-term regulatory and commercial advisory for an international pharmaceutical company \u2014 multi-product registration in the State Register of Medicines, Ministry of Health import licensing, distribution agreement structuring, ASL Belgisi serialisation compliance, and ongoing regulatory liaison.<\/p>\n<\/div>\n
Generic Pharmaceutical Manufacturer \u2014 Import Licensing & Distribution<\/p>\n
Pharma \u00b7 Product Registration \u00b7 Distribution \u00b7 Import Licence<\/p>\n
Advising a generic pharmaceutical manufacturer on multi-product registration in the State Register of Medicines, import licence applications, distributor agreement drafting under Uzbek civil law, and compliance with ASL Belgisi mandatory serialisation requirements.<\/p>\n<\/div>\n
European Pharma Company \u2014 GMP & Market Entry Structuring<\/p>\n
Pharma \u00b7 GMP \u00b7 Market Entry \u00b7 Ministry of Health<\/p>\n
Advising a European pharmaceutical manufacturer on GMP certification pathway, product registration dossier requirements, and optimal market entry structure \u2014 subsidiary formation vs. licensed distributor \u2014 for initial entry into the Uzbek market.<\/p>\n<\/div>\n
ASL Belgisi Compliance \u2014 Multi-Client Advisory<\/p>\n
Pharma \u00b7 Serialisation \u00b7 ASL Belgisi \u00b7 Compliance<\/p>\n
Advising multiple international pharmaceutical importers on ASL Belgisi mandatory serialisation compliance \u2014 Electronic Digital Signature (EDS) registration, system integration requirements, event reporting obligations, and customs clearance procedures for serialised product shipments.<\/p>\n<\/div>\n<\/div>\n