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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

Cabinet of Ministers Resolution · No. 324 · 24 June 2026Checked against the official sourceOn electronic confirmation by authorized bodies for releasing goods into free circulation on the basis of internationally recognized documentsMedicinesMedical devices and equipmentDietary supplementsCosmeticsSports nutrition
Presidential Resolution · No. PP-197 · 20 June 2023Checked against the official sourceMeasures for effective organisation of public administration in healthcare under administrative reformsMedicinesMedical devices and equipment
Pharmaceutical Safety Center guidelineNeeds reviewGuidance on medicinal-product application assessmentMedicines
Pharmaceutical Safety Center guidelineNeeds reviewGuidance on expert assessment of registration documentsMedicines
Pharmaceutical Safety Center guidelineNeeds reviewGood Review Practice guidance — GrevPMedicines
Pharmaceutical Safety Center guidelineNeeds reviewGuidance on package leaflets and summaries of product characteristicsMedicines

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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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