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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

Presidential Decree · No. UP-191 · 10 September 2026Checked against the official sourceMedical and pharmaceutical training reform — pharmaceutical-circulation amendments in the annexMedicines
Cabinet of Ministers Resolution · No. 396 · 21 July 2026Checked against the official sourceOn the regulations governing the Food Safety CommitteeDietary supplementsSports nutrition
Presidential Resolution · No. PP-238 · 24 June 2026Checked against the official sourceImproving prevention, early detection and treatment of cancerMedical devices and equipmentMedicines
Presidential Decree · No. UP-77 · 5 May 2026Checked against the official sourceImproving management efficiency in the healthcare systemMedical devices and equipmentMedicines
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. 12 · 27 April 2026Checked against the official sourceAmendments to medical-device nomenclature and risk-classification rulesMedical devices and equipment

All documents by section

Order of the Minister of Health · No. 2 · 14 April 2026Procedure for inspecting the manufacturing conditions of medical devices during state registration
Order of the Minister of Health · No. 16 · 24 December 2025Medical-device nomenclature and risk classification
Cabinet of Ministers Resolution · No. 738 · 24 November 2025State-registration procedures for medicines and medical devices
Cabinet of Ministers Resolution · No. 720 · 13 November 2025On the administrative regulation for issuing sanitary-epidemiological conclusions on food and agricultural products
Order of the Minister of Health · No. 12 · 21 October 2025Classifiers of key medicinal-product pharmacological characteristics
Presidential Decree · No. UP-137 · 19 August 2025Additional measures regulating the circulation of medicines and medical devices
Order of the Minister of Health · No. 6 · 28 July 2025Amendments to the list of medicines and devices allowed for use and import without state registration subject to mandatory certification
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
Cabinet of Ministers Resolution · No. 67 · 7 February 2025Amendments to certain Government decisions (incl. registration Regulations No. 213 and No. 862 of 2018)
Cabinet of Ministers Resolution · No. 48 · 29 January 2025On the Regulation on the Committee for Sanitary and Epidemiological Welfare and Public Health
Order of the Minister of Health · No. 31 · 3 January 2025Regulation on state registration of certain medicines without clinical trials
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
Law of the Republic of Uzbekistan · No. ZRU-908 · 15 February 2024Amendments to legislative acts aligning national legislation with WTO agreements
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
InstructionMedical-device registration-document requirements — Center source
Pharmaceutical Safety Center guidelineGuidance on expert assessment of registration documents
Pharmaceutical Safety Center guidelineGood Review Practice guidance — GrevP
Pharmaceutical Safety Center guidelineGuidance on package leaflets and summaries of product characteristics
OrderMedicine and medical-device registration fees — Center source
Pharmaceutical Safety Center guidelineGuidance on suspension and cancellation of registration certificates
Pharmaceutical Safety Center guidelineGuidance on variations to medicinal-product registration documents

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