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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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Found: 12

Latest documents

Presidential Decree · No. UP-74 · 5 May 2026Checked against the official sourceMeasures for additional support of the private sector in medicineMedical devices and equipmentMedicines
Presidential Decree · No. UP-13 · 28 January 2025Checked against the official sourceAdditional measures to accelerate pharmaceutical-sector development — UP-13Medicines
Presidential Decree · No. UP-20 · 23 January 2024Checked against the official sourceAdditional measures regulating the pharmaceutical sector — UP-20Medicines
Presidential Decree · No. UP-55 · 21 January 2022Checked against the official sourcePharmaceutical-sector development measures for 2022–2026 — UP-55Medicines
Presidential Decree · No. UP-191 · 10 September 2026Checked against the official sourceMedical and pharmaceutical training reform — pharmaceutical-circulation amendments in the annexMedicines
Presidential Decree · No. UP-35 · 5 March 2026Checked against the official sourceAdditional measures supporting pharmaceutical manufacturing and research — UP-35Medicines

All documents by section

Registration and dossier1 docs

Order of the Minister of Health · No. 7 · 30 April 2026Requirements for medicinal-product state-registration documents

Circulation, import and labelling1 docs

Cabinet of Ministers Resolution · No. 185 · 6 April 2017Implementation of the sector law — distribution, pharmacy sales and withdrawal

Prices, procurement and reimbursement2 docs

Presidential Resolution · No. PP-4554 · 30 December 2019Additional measures to deepen reforms in the pharmaceutical sector
Law of the Republic of Uzbekistan · No. ZRU-701 · 14 July 2021Licensing, Permit and Notification Procedures Act

Framework and sector reforms2 docs

Presidential Decree · No. UP-5229 · 7 November 2017Measures to radically improve the management system of the pharmaceutical industry
Law of the Republic of Uzbekistan · No. ZRU-399 · 4 January 2016Amendment Act No. ZRU-399 — new edition of the Medicines and Pharmaceutical Activity Act

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