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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. 472 · 7 September 2026Checked against the official sourceOn additional measures to improve legislation on technical regulationMedicines
Presidential Decree · No. UP-25 · 16 February 2026Checked against the official sourceAccelerating technical regulation reforms based on international practiceMedical devices and equipmentCosmetics
Cabinet of Ministers Resolution · No. 153 · 25 March 2024Checked against the official sourceOn measures to implement the Law on Technical RegulationCosmeticsMedical devices and equipment
Law of the Republic of Uzbekistan · No. ZRU-819 · 27 February 2023Checked against the official sourceLaw on Technical RegulationCosmeticsMedical devices and equipmentDietary supplementsSports nutrition
Cabinet of Ministers Resolution · No. 365 · 27 October 2016Checked against the official sourceGeneral technical regulation on medicinal-product safetyMedicines
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

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Quality, GxP and pharmacopoeia2 docs

Law of the Republic of Uzbekistan · No. ZRU-1088 · 17 October 2025On amendments raising the liability of conformity assessment bodies and granting privileges to businesses that voluntarily recall products
Cabinet of Ministers Resolution · No. 554 · 2 September 2025On amendments to certain Government decisions to simplify conformity assessment procedures

Safety and post-marketing control2 docs

Cabinet of Ministers Resolution · No. 553 · 2 September 2025On amendments to and repeal of certain Government resolutions (September 2025)
Presidential Decree · No. UP-67 · 18 April 2025On stimulating production, export and business activity

Licensing and supervision1 docs

Presidential Decree · No. UP-8 · 9 January 2024On reducing mandatory requirements and simplifying licensing and permit procedures for business

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