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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

Law of the Republic of Uzbekistan · No. ZRU-776 · 7 June 2022Checked against the official sourceOn advertisingMedicinesDietary supplementsCosmetics
Law of the Republic of Uzbekistan · No. 221-I · 26 April 1996Checked against the official sourceOn protection of consumer rightsMedicinesMedical devices and equipmentDietary supplementsCosmeticsSports nutrition
Order of the Minister of Health · No. 5 · 2 March 2026Checked against the official sourceAdditions to the list of orphan medicines for rare diseases and medical devices for diagnosis and treatment of rare diseasesMedical devices and equipmentMedicines
Order of the Minister of Health · No. 24 · 5 January 2026Checked against the official sourceImport and use of temporarily scarce medicines and devices without state registration, subject to certificationMedicinesMedical devices and equipment
Order of the Minister of Health · No. 9 · 27 June 2025Checked against the official sourceAdditions to the list of orphan medicines for rare diseases and medical devices for rare diseasesMedicinesMedical devices and equipment
Order of the Minister of Health · No. 34 · 21 August 2023Checked against the official sourceList of essential medicinesMedicines

All documents by section

Cabinet of Ministers Resolution · No. 149 · 2 April 2022Introduction of mandatory digital labeling of medicines and medical devices
Order of the Minister of Health · No. 121 · 1 July 2020Regulation on prescribing medicines in health facilities, writing prescriptions by INN and receiving, storing and using patients’ own medicines
Order of the Minister of Health · No. 122 · 8 June 2020Approval of orphan medicines for rare diseases and the list of medical equipment for rare diseases
Presidential Resolution · No. PP-3489 · 23 January 2018Further regulation of production and import of medicines and medical devices
Cabinet of Ministers Resolution · No. 191 · 8 June 2016Approval of rules for personal-use import and export of medicines and medical products
Cabinet of Ministers Resolution · No. 341 · 15 December 2014Regulation on issuing permits for advertising medicines to minors
Sanitary rules and normsSanitary rules for the design, equipment and operation of medicine and medical device storage warehouses
Presidential Decree · No. UP-174 · 27 August 2026Improving customs bodies and modern customs administration
Cabinet of Ministers Resolution · No. 353 · 30 June 2026Amendments to and repeal of certain Government resolutions (incl. new wording of Resolution No. 185 on pharmaceutical trade)
Presidential Resolution · No. PP-136 · 13 April 2026Measures to create favourable conditions for further development of e-commerce
Cabinet of Ministers Resolution · No. 737 · 21 November 2025Measures to further improve mechanisms of public procurement of pharmaceutical products
Cabinet of Ministers Resolution · No. 700 · 6 November 2025On further improving certain customs procedures
Presidential Resolution · No. PP-295 · 4 October 2025Additional measures for accelerated industrial development in the regions and export promotion
Presidential Resolution · No. PP-190 · 23 May 2025Additional measures to improve the efficiency of mandatory digital marking
Cabinet of Ministers Resolution · No. 478 · 3 August 2024On regulating retail trade in goods subject to mandatory digital marking
Presidential Resolution · No. PP-110 · 4 April 2023On additional measures to supply the population with quality consumer goods
Cabinet of Ministers Resolution · No. 22 · 5 February 2014Improvement of labeling and customs clearance of selected imported consumer goods

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