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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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Found: 21

Latest documents

Cabinet of Ministers Resolution · No. 396 · 21 July 2026Checked against the official sourceOn the regulations governing the Food Safety CommitteeDietary supplementsSports nutrition
Presidential Decree · No. UP-84 · 12 May 2026Checked against the official sourceOn a single state management and control system for food safety, phytosanitary and veterinary mattersDietary supplementsSports nutrition
Presidential Resolution · No. PP-178 · 12 May 2026Checked against the official sourceOn organizing the work of the Food Safety CommitteeDietary supplements
Order of the Minister of Health · No. 18 · 30 December 2025Checked against the official sourcePharmacovigilance and medical-device safety monitoringMedicinesMedical devices and equipment
Cabinet of Ministers Resolution · No. 365 · 27 October 2016Checked against the official sourceGeneral technical regulation on medicinal-product safetyMedicines
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

All documents by section

Registration and dossier6 docs

Pharmaceutical Safety Center guidelineGuidance on medicinal-product application assessment
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
Pharmaceutical Safety Center guidelineGuidance on suspension and cancellation of registration certificates
Pharmaceutical Safety Center guidelineGuidance on variations to medicinal-product registration documents

Safety and post-marketing control3 docs

State standard · No. SanPiN 0340-16 · 21 December 2016Hygienic requirements for the production and safety of perfume and cosmetic products
Cabinet of Ministers Resolution · No. 553 · 2 September 2025On amendments to and repeal of certain Government resolutions (September 2025)
Presidential Decree · No. UP-20 · 23 January 2024Additional measures regulating the pharmaceutical sector — UP-20

Licensing and supervision1 docs

Cabinet of Ministers Resolution · No. 86 · 22 February 2022On the Unified Regulation on issuing certain permits through a special electronic system

Circulation, import and labelling3 docs

Sanitary rules and norms · No. 0110-26SanPiN No. 0110-26: sanitary rules for the production, safety and circulation of dietary supplements
Cabinet of Ministers Resolution · No. 324 · 24 June 2026On electronic confirmation by authorized bodies for releasing goods into free circulation on the basis of internationally recognized documents
Presidential Resolution · No. PP-110 · 4 April 2023On additional measures to supply the population with quality consumer goods

Framework and sector reforms2 docs

Presidential Resolution · No. PP-197 · 20 June 2023Measures for effective organisation of public administration in healthcare under administrative reforms
Law of the Republic of Uzbekistan · No. ZRU-819 · 27 February 2023Law on Technical Regulation

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