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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

Cabinet of Ministers Resolution · No. 353 · 30 June 2026Checked against the official sourceAmendments to and repeal of certain Government resolutions (incl. new wording of Resolution No. 185 on pharmaceutical trade)Medical devices and equipmentMedicines
Cabinet of Ministers Resolution · No. 154 · 9 April 2026Checked against the official sourceOn amendments to and repeal of certain Government resolutions (April 2026)Dietary supplements
Cabinet of Ministers Resolution · No. 662 · 21 October 2025Checked against the official sourceAmendments to and repeal of certain Government resolutions (incl. pricing provisions of Resolution No. 185)Medicines
Cabinet of Ministers Resolution · No. 553 · 2 September 2025Checked against the official sourceOn amendments to and repeal of certain Government resolutions (September 2025)Dietary supplementsSports nutrition
Cabinet of Ministers Resolution · No. 472 · 7 September 2026Checked against the official sourceOn additional measures to improve legislation on technical regulationMedicines
Cabinet of Ministers Resolution · No. 502 · 14 August 2024Checked against the official sourceOn approval of regulations on product state registration and conformity assessment proceduresCosmeticsMedical devices and equipment

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Registration and dossier3 docs

Cabinet of Ministers Resolution · No. 862 · 24 October 2018Recognition of overseas medicinal-product registration results — 2018 resolution
Presidential Resolution · No. PP-3948 · 24 September 2018Additional measures on registration and circulation of medicines — PP-3948
Cabinet of Ministers Resolution · No. 213 · 23 March 2018Former medicine and medical-device registration procedure — Resolution No. 213

Quality, GxP and pharmacopoeia1 docs

Presidential Resolution · No. PP-411 · 26 October 2022Measures to supply quality medicines and medical products — PP-411

Clinical trials1 docs

Order of the Minister of Health · No. 12 · 16 May 2023Former clinical-trial procedure — Justice registration No. 3439

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