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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

Section

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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Found: 6

Order of the Minister of Health · No. 14 · 10 April 2026Checked against the official sourceProcedure for setting fees for GxP pharmaceutical inspection of pharmaceutical enterprises and preclinical and clinical research sitesMedicinesMedical devices and equipment
Cabinet of Ministers Resolution · No. 788 · 18 September 2019Checked against the official sourceImplementation of good-practice requirements and GxP inspectionsMedicines
Presidential Resolution · No. PP-238 · 24 June 2026Checked against the official sourceImproving prevention, early detection and treatment of cancerMedical devices and equipmentMedicines
Order of the Minister of Health · No. 2 · 14 April 2026Checked against the official sourceProcedure for inspecting the manufacturing conditions of medical devices during state registrationMedical devices and equipmentMedicines
Presidential Resolution · No. PP-203 · 30 May 2024Checked against the official sourceOn additional measures to accelerate mandatory digital markingMedicinesMedical devices and equipment
Presidential Decree · No. UP-20 · 23 January 2024Checked against the official sourceAdditional measures regulating the pharmaceutical sector — UP-20Medicines

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