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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. 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
Order of the Minister of Health · No. 13 · 16 December 2025Checked against the official sourceCertification-rule amendments covering GMP and ISO 13485 — No. 3386-2MedicinesMedical 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
Order of the Minister of Health · No. 8 · 26 May 2025Checked against the official source2025 amendments to pharmaceutical-product certification rules — No. 3386-1Medicines
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. 16 · 27 July 2022Checked against the official sourcePharmaceutical-product certification rulesMedicines

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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. 43 · 30 January 2021On approval of the lists of products subject to mandatory conformity confirmation

Framework and sector reforms1 docs

Presidential Resolution · No. PP-197 · 20 June 2023Measures for effective organisation of public administration in healthcare under administrative reforms

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