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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 · 2 March 2026Checked against the official sourceAdditions to the list of orphan medicines for rare diseases and medical devices for diagnosis and treatment of rare diseasesMedical devices and equipmentMedicines
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
Order of the Minister of Health · No. 9 · 27 June 2025Checked against the official sourceAdditions to the list of orphan medicines for rare diseases and medical devices for rare diseasesMedicinesMedical devices and equipment
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
Order of the Minister of Health · No. 34 · 21 August 2023Checked against the official sourceList of essential medicinesMedicines
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

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Registration and dossier6 docs

Order of the Minister of Health · No. 7 · 30 April 2026Requirements for medicinal-product state-registration documents
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
Pharmaceutical Safety Center guidelineGuidance on package leaflets and summaries of product characteristics

Quality, GxP and pharmacopoeia1 docs

Cabinet of Ministers Resolution · No. 472 · 7 September 2026On additional measures to improve legislation on technical regulation

Circulation, import and labelling2 docs

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. 221-I · 26 April 1996On protection of consumer rights

Prices, procurement and reimbursement1 docs

Order of the Minister of Health · No. 18 · 23 April 2026List of diseases included in the reimbursement programme and medicines provided for their treatment

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