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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

Law of the Republic of Uzbekistan · No. ZRU-908 · 15 February 2024Checked against the official sourceAmendments to legislative acts aligning national legislation with WTO agreementsMedicines
Order of the Minister of Health · No. 7 · 30 April 2026Checked against the official sourceRequirements for medicinal-product state-registration documentsMedicines
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. 12 · 21 October 2025Checked against the official sourceClassifiers of key medicinal-product pharmacological characteristicsMedicines
Presidential Decree · No. UP-137 · 19 August 2025Checked against the official sourceAdditional measures regulating the circulation of 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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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 · 6 September 2024On reviewing applications of foreign manufacturers of medicines, medical devices and equipment and approving fees for issuing, amending, extending, re-issuing and duplicating the certificate
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. 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
Pharmaceutical Safety Center guidelineGuidance on medicinal-product application assessment
OrderMedicine and medical-device registration fees — Center source
Pharmaceutical Safety Center guidelineGuidance on variations to medicinal-product registration documents
Presidential Resolution · No. PP-238 · 24 June 2026Improving prevention, early detection and treatment of cancer
Presidential Decree · No. UP-77 · 5 May 2026Improving management efficiency in the healthcare system
Pharmaceutical Safety Center guidelineGuidance on package leaflets and summaries of product characteristics

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