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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: 11

Latest documents

Cabinet of Ministers Resolution · No. 149 · 2 April 2022Checked against the official sourceIntroduction of mandatory digital labeling of medicines and medical devicesMedicinesMedical devices and equipment
Cabinet of Ministers Resolution · No. 737 · 20 November 2020Checked against the official sourceIntroduction of mandatory digital labeling for selected product categoriesMedicines
Cabinet of Ministers Resolution · No. 22 · 5 February 2014Checked against the official sourceImprovement of labeling and customs clearance of selected imported consumer goodsMedicines
Presidential Resolution · No. PP-178 · 12 May 2026Checked against the official sourceOn organizing the work of the Food Safety CommitteeDietary supplements
Cabinet of Ministers Resolution · No. 553 · 2 September 2025Checked against the official sourceOn amendments to and repeal of certain Government resolutions (September 2025)Dietary supplementsSports nutrition
Presidential Decree · No. UP-36 · 16 February 2024Checked against the official sourceOn additional measures to ensure food securityDietary supplements

All documents by section

Registration and dossier1 docs

Cabinet of Ministers Resolution · No. 213 · 23 March 2018Former medicine and medical-device registration procedure — Resolution No. 213

Quality, GxP and pharmacopoeia1 docs

Cabinet of Ministers Resolution · No. 365 · 27 October 2016General technical regulation on medicinal-product safety

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 labelling1 docs

Law of the Republic of Uzbekistan · No. 221-I · 26 April 1996On protection of consumer rights

Framework and sector reforms1 docs

Law of the Republic of Uzbekistan · No. 483-I · 30 August 1997On the quality and safety of food products

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