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PHARMALEXREGULATORY AFFAIRS · UZBEKISTAN

Medicine registrationNew medicines, generics and biologics: from dossier to certificate.
Medical device registrationDevices of every risk class: technical file, testing, expert review.
Medical equipment registrationEquipment for clinics and laboratories, including service documents.
Re-registrationWe renew the registration before the certificate expires.
VariationsA new manufacturer, pack, composition or patient leaflet.
Dietary supplement registrationImport and production permit, sanitary-epidemiological conclusion.

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PHARMALEXREGULATORY AFFAIRS · UZBEKISTAN

Pharmalex registers medicines, medical devices and equipment, and dietary supplements in Uzbekistan for foreign manufacturers and importers.

PHARMALEX Private Enterprise7a/31 Yangi Olmazor Street, Almazar District, Tashkent 100000, Uzbekistan+998 94 050 66 88 info@pharmalex.uz

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Medicine registration Medical device registration Medical equipment registration Re-registration Variations Dietary supplement registration

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All documents Medicines Medical devices and equipment Dietary supplements Cosmetics Sports nutrition

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All documents159 Registration and dossier30 Quality, GxP and pharmacopoeia22 Safety and post-marketing control8 Clinical trials4 Licensing and supervision6 Circulation, import and labelling44 Controlled substances15 Prices, procurement and reimbursement10 Framework and sector reforms20

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Latest documents

Presidential Decree · No. UP-77 · 5 May 2026Checked against the official sourceImproving management efficiency in the healthcare systemMedical devices and equipmentMedicines
Order of the Minister of Health · No. 25 · 15 December 2025Checked against the official sourceProcedure for phased introduction of the E-prescription systemMedicines
Cabinet of Ministers Resolution · No. 713 · 10 November 2025Checked against the official sourceAmendment to Annex 37 to the Unified Regulation on licensing via the special electronic system (Resolution No. 80 of 21.02.2022)Medicines
Presidential Resolution · No. PP-408 · 29 November 2024Checked against the official sourceImprovement of the system for supplying medical institutions with pharmaceutical products and medical equipmentMedicines
Cabinet of Ministers Resolution · No. 725 · 31 October 2024Checked against the official sourceAmendment and addition to the Unified Regulation on licensing via the special electronic system (narcotics, psychotropics and precursors)Medicines
Cabinet of Ministers Resolution · No. 86 · 22 February 2022Checked against the official sourceOn the Unified Regulation on issuing certain permits through a special electronic systemCosmeticsDietary supplements

All documents by section

Quality, GxP and pharmacopoeia2 docs

Cabinet of Ministers Resolution · No. 554 · 2 September 2025On amendments to certain Government decisions to simplify conformity assessment procedures
Cabinet of Ministers Resolution · No. 502 · 14 August 2024On approval of regulations on product state registration and conformity assessment procedures

Licensing and supervision3 docs

Order of the Minister of Health · No. 24 · 26 August 2026Risk-analysis system for pharmaceutical regulatory compliance oversight
Cabinet of Ministers Resolution · No. 577 · 19 October 2026On introducing a system that grants medical and pharmaceutical workers the right to practise through state registration
Presidential Decree · No. UP-192 · 10 September 2026On introducing a system of state registration of medical and pharmaceutical workers

Circulation, import and labelling7 docs

Cabinet of Ministers Resolution · No. 570 · 8 September 2025Additional measures to accelerate digitalization of the healthcare system
Cabinet of Ministers Resolution · No. 738 · 18 September 2018Measures to further improve the system of supplying the population with pharmaceutical products
Order of the Minister of Health · No. 19 · 24 December 2025Instruction on using the E-polyclinic, E-hospital, E-medical record and E-prescription modules of the E-health information system
Cabinet of Ministers Resolution · No. 23 · 23 January 2026On additional measures to improve the mandatory digital marking system
Presidential Resolution · No. PP-296 · 6 October 2025On organizing effective consumer rights protection
Cabinet of Ministers Resolution · No. 149 · 2 April 2022Introduction of mandatory digital labeling of medicines and medical devices
Cabinet of Ministers Resolution · No. 737 · 20 November 2020Introduction of mandatory digital labeling for selected product categories

Prices, procurement and reimbursement2 docs

Order of the Minister of Health · No. 23 · 10 December 2025Approval of the regulation on recording prescription medicine prices under the reference pricing system
Cabinet of Ministers Resolution · No. 80 · 21 February 2022Electronic licensing procedure — pharmaceutical licensing passport

Framework and sector reforms2 docs

Presidential Decree · No. UP-5229 · 7 November 2017Measures to radically improve the management system of the pharmaceutical industry
Presidential Decree · No. UP-84 · 12 May 2026On a single state management and control system for food safety, phytosanitary and veterinary matters

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