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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 Resolution · No. PP-110 · 4 April 2023Checked against the official sourceOn additional measures to supply the population with quality consumer goodsMedicinesMedical devices and equipment
Presidential Resolution · No. PP-411 · 26 October 2022Checked against the official sourceMeasures to supply quality medicines and medical products — PP-411Medicines
Presidential Resolution · No. PP-393 · 12 October 2022Checked against the official sourceOn supplying the population with quality international-brand products and integrating domestic firms into global value chainsCosmetics
Order of the Minister of Health · No. 17 · 27 March 2018Checked against the official sourceApproval of the regulation on preparation, storage, quality control and documentation of medicines and medical devicesMedicinesMedical devices and equipment
Law of the Republic of Uzbekistan · No. 483-I · 30 August 1997Checked against the official sourceOn the quality and safety of food productsDietary supplementsSports nutritionCosmetics
Presidential Decree · No. UP-192 · 10 September 2026Checked against the official sourceOn introducing a system of state registration of medical and pharmaceutical workersMedicines

All documents by section

Registration and dossier1 docs

Presidential Decree · No. UP-137 · 19 August 2025Additional measures regulating the circulation of medicines and medical devices

Quality, GxP and pharmacopoeia7 docs

Order of the Minister of Health · No. 13 · 16 December 2025Certification-rule amendments covering GMP and ISO 13485 — No. 3386-2
Order of the Minister of Health · No. 14 · 12 December 2025Development and inclusion of general and individual pharmacopoeial monographs
Order of the Minister of Health · No. 8 · 26 May 20252025 amendments to pharmaceutical-product certification rules — No. 3386-1
Order of the Minister of Health · No. 16 · 27 July 2022Pharmaceutical-product certification rules
Presidential Decree · No. UP-55 · 21 January 2022Pharmaceutical-sector development measures for 2022–2026 — UP-55
Cabinet of Ministers Resolution · No. 486 · 3 August 2021Additional measures to implement good practice (GxP) requirements in the pharmaceutical industry
Cabinet of Ministers Resolution · No. 365 · 27 October 2016General technical regulation on medicinal-product safety

Safety and post-marketing control2 docs

Cabinet of Ministers Resolution · No. 628 · 4 October 2024Post-marketing control of pharmaceutical products
Presidential Decree · No. UP-20 · 23 January 2024Additional measures regulating the pharmaceutical sector — UP-20

Licensing and supervision1 docs

Cabinet of Ministers Resolution · No. 577 · 19 October 2026On introducing a system that grants medical and pharmaceutical workers the right to practise through state registration

Framework and sector reforms1 docs

Presidential Decree · No. UP-13 · 28 January 2025Additional measures to accelerate pharmaceutical-sector development — UP-13

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