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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

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
Presidential Resolution · No. PP-374 · 13 December 2025Checked against the official sourceAmending the reduced import duty rates for certain international-brand goods imported under direct contracts with brand ownersCosmetics
Order of the Minister of Health · No. 6 · 28 July 2025Checked against the official sourceAmendments to the list of medicines and devices allowed for use and import without state registration subject to mandatory certificationMedical devices and equipmentMedicines
Order of the Minister of Health · No. 5 · 27 February 2025Checked against the official sourceList of medicines and medical equipment allowed for use and import without state registration subject to mandatory certification and lacking registered analoguesMedical devices and equipmentMedicines
Presidential Resolution · No. PP-3489 · 23 January 2018Checked against the official sourceFurther regulation of production and import of medicines and medical devicesMedicinesMedical devices and equipment
Cabinet of Ministers Resolution · No. 191 · 8 June 2016Checked against the official sourceApproval of rules for personal-use import and export of medicines and medical productsMedicines

All documents by section

Registration and dossier2 docs

Cabinet of Ministers Resolution · No. 396 · 21 July 2026On the regulations governing the Food Safety Committee
Presidential Resolution · No. PP-238 · 24 June 2026Improving prevention, early detection and treatment of cancer

Safety and post-marketing control1 docs

Law of the Republic of Uzbekistan · No. ZRU-393 · 26 August 2015On the sanitary and epidemiological welfare of the population

Licensing and supervision3 docs

Cabinet of Ministers Resolution · No. 847 · 18 December 2024On amendments to certain Government resolutions (December 2024)
Presidential Decree · No. UP-8 · 9 January 2024On reducing mandatory requirements and simplifying licensing and permit procedures for business
Cabinet of Ministers Resolution · No. 86 · 22 February 2022On the Unified Regulation on issuing certain permits through a special electronic system

Circulation, import and labelling9 docs

Cabinet of Ministers Resolution · No. 22 · 5 February 2014Improvement of labeling and customs clearance of selected imported consumer goods
Presidential Decree · No. UP-174 · 27 August 2026Improving customs bodies and modern customs administration
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
Cabinet of Ministers Resolution · No. 154 · 9 April 2026On amendments to and repeal of certain Government resolutions (April 2026)
Cabinet of Ministers Resolution · No. 700 · 6 November 2025On further improving certain customs procedures
Presidential Resolution · No. PP-190 · 23 May 2025Additional measures to improve the efficiency of mandatory digital marking
Cabinet of Ministers Resolution · No. 244 · 19 April 2025On improving the procedure for moving certain goods across the customs border
Presidential Resolution · No. PP-393 · 12 October 2022On supplying the population with quality international-brand products and integrating domestic firms into global value chains
Cabinet of Ministers Resolution · No. 149 · 2 April 2022Introduction of mandatory digital labeling of medicines and medical devices

Controlled substances3 docs

Cabinet of Ministers Resolution · No. 330 · 12 November 2015Improvement of import, export and transit procedures for narcotic drugs, psychotropic substances and precursors and control of their circulation
Cabinet of Ministers Resolution · No. 359 · 2 July 2026Further improvement of narcotic drug and psychotropic substance circulation regulation in Uzbekistan
Cabinet of Ministers Resolution · No. 337 · 26 June 2026Regulation of precursor-related activities and continuous control in Uzbekistan

Prices, procurement and reimbursement1 docs

Cabinet of Ministers Resolution · No. 662 · 21 October 2025Amendments to and repeal of certain Government resolutions (incl. pricing provisions of Resolution No. 185)

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