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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

Order of the Minister of Health · No. 5 · 27 February 2025Checked against the official sourceList of medicines and medical equipment allowed for use and import without state registration subject to mandatory certification and lacking registered analoguesMedical devices and equipmentMedicines
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
Order of the Minister of Health · No. 122 · 8 June 2020Checked against the official sourceApproval of orphan medicines for rare diseases and the list of medical equipment for rare diseasesMedicinesMedical devices and equipment
Order of the Minister of Health · No. 31 · 6 September 2024Checked against the official sourceOn reviewing applications of foreign manufacturers of medicines, medical devices and equipment and approving fees for issuing, amending, extending, re-issuing and duplicating the certificateMedical devices and equipmentMedicines
Cabinet of Ministers Resolution · No. 112 · 15 February 2018Checked against the official sourceMetrological control of laboratory and diagnostic equipment used in medicineMedical devices and equipment
Sanitary rules and normsNeeds reviewSanitary rules for the design, equipment and operation of medicine and medical device storage warehousesMedicinesMedical devices and equipment

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Registration and dossier1 docs

Cabinet of Ministers Resolution · No. 213 · 23 March 2018Former medicine and medical-device registration procedure — Resolution No. 213

Quality, GxP and pharmacopoeia1 docs

Cabinet of Ministers Resolution · No. 564 · 12 September 2024List of measuring instrument groups of state significance; separation of verification and state metrological control

Circulation, import and labelling2 docs

Cabinet of Ministers Resolution · No. 353 · 30 June 2026Amendments to and repeal of certain Government resolutions (incl. new wording of Resolution No. 185 on pharmaceutical trade)
Presidential Resolution · No. PP-295 · 4 October 2025Additional measures for accelerated industrial development in the regions and export promotion

Framework and sector reforms1 docs

Law of the Republic of Uzbekistan · No. ZRU-614 · 7 April 2020Law on Metrology (new edition by Law ZRU-614)

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