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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: 18

Latest documents

Presidential Decree · No. UP-192 · 10 September 2026Checked against the official sourceOn introducing a system of state registration of medical and pharmaceutical workersMedicines
Order of the Minister of Health · No. 7 · 30 April 2026Checked against the official sourceRequirements for medicinal-product state-registration documentsMedicines
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
Order of the Minister of Health · No. 24 · 5 January 2026Checked against the official sourceImport and use of temporarily scarce medicines and devices without state registration, subject to certificationMedicinesMedical devices and equipment
Cabinet of Ministers Resolution · No. 738 · 24 November 2025Checked against the official sourceState-registration procedures for medicines and medical devicesMedicinesMedical devices and equipment
Order of the Minister of Health · No. 6 · 28 July 2025Checked against the official sourceAmendments to the list of medicines and devices allowed for use and import without state registration subject to mandatory certificationMedical devices and equipmentMedicines

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Registration and dossier3 docs

Order of the Minister of Health · No. 5 · 27 February 2025List of medicines and medical equipment allowed for use and import without state registration subject to mandatory certification and lacking registered analogues
Order of the Minister of Health · No. 31 · 3 January 2025Regulation on state registration of certain medicines without clinical trials
Cabinet of Ministers Resolution · No. 48 · 29 January 2025On the Regulation on the Committee for Sanitary and Epidemiological Welfare and Public Health

Quality, GxP and pharmacopoeia2 docs

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

Licensing and supervision1 docs

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

Circulation, import and labelling3 docs

Presidential Decree · No. UP-174 · 27 August 2026Improving customs bodies and modern customs administration
Presidential Resolution · No. PP-295 · 4 October 2025Additional measures for accelerated industrial development in the regions and export promotion
Law of the Republic of Uzbekistan · No. ZRU-776 · 7 June 2022On advertising

Framework and sector reforms3 docs

Presidential Resolution · No. PP-197 · 20 June 2023Measures for effective organisation of public administration in healthcare under administrative reforms
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
Law of the Republic of Uzbekistan · No. 483-I · 30 August 1997On the quality and safety of food products

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