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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-1173 · 10 September 2026Historical versionOn amendments and additions to certain legislative acts of the Republic of Uzbekistan aimed at improving e-commerceDietary supplementsCosmeticsSports nutrition
Presidential Decree · No. UP-174 · 27 August 2026Checked against the official sourceImproving customs bodies and modern customs administrationMedical devices and equipmentMedicines
Cabinet of Ministers Resolution · No. 353 · 30 June 2026Checked against the official sourceAmendments to and repeal of certain Government resolutions (incl. new wording of Resolution No. 185 on pharmaceutical trade)Medical devices and equipmentMedicines
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
Order of the Minister of Health · No. 15 · 30 April 2026Checked against the official sourceAmendments to certain departmental acts of the Ministry of Health (medical device terminology)Medical devices and equipmentMedicines
Presidential Resolution · No. PP-136 · 13 April 2026Checked against the official sourceMeasures to create favourable conditions for further development of e-commerceMedicines

All documents by section

Cabinet of Ministers Resolution · No. 154 · 9 April 2026On amendments to and repeal of certain Government resolutions (April 2026)
Law of the Republic of Uzbekistan · No. ZRU-1120 · 6 March 2026Amendments to certain legislative acts (incl. stricter liability for breaching prescription retail rules)
Order of the Minister of Health · No. 5 · 2 March 2026Additions to the list of orphan medicines for rare diseases and medical devices for diagnosis and treatment of rare diseases
Cabinet of Ministers Resolution · No. 23 · 23 January 2026On additional measures to improve the mandatory digital marking system
Order of the Minister of Health · No. 24 · 5 January 2026Import and use of temporarily scarce medicines and devices without state registration, subject to certification
Order of the Minister of Health · No. 19 · 24 December 2025Instruction on using the E-polyclinic, E-hospital, E-medical record and E-prescription modules of the E-health information system
Order of the Minister of Health · No. 25 · 15 December 2025Procedure for phased introduction of the E-prescription system
Presidential Resolution · No. PP-374 · 13 December 2025Amending the reduced import duty rates for certain international-brand goods imported under direct contracts with brand owners
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-296 · 6 October 2025On organizing effective consumer rights protection
Presidential Resolution · No. PP-295 · 4 October 2025Additional measures for accelerated industrial development in the regions and export promotion
Cabinet of Ministers Resolution · No. 570 · 8 September 2025Additional measures to accelerate digitalization of the healthcare system
Order of the Minister of Health · No. 9 · 27 June 2025Additions to the list of orphan medicines for rare diseases and medical devices for rare diseases
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
Cabinet of Ministers Resolution · No. 478 · 3 August 2024On regulating retail trade in goods subject to mandatory digital marking
Presidential Resolution · No. PP-203 · 30 May 2024On additional measures to accelerate mandatory digital marking
Sanitary rules and norms · No. 10 · 5 April 2024Approval of sanitary rules, standards and hygiene requirements for pharmacy location and equipment (SanQvaN No. 0071-24)
Order of the Minister of Health · No. 34 · 21 August 2023List of essential medicines
Presidential Resolution · No. PP-110 · 4 April 2023On additional measures to supply the population with quality consumer goods
Presidential Resolution · No. PP-393 · 12 October 2022On supplying the population with quality international-brand products and integrating domestic firms into global value chains
Law of the Republic of Uzbekistan · No. ZRU-776 · 7 June 2022On advertising
Cabinet of Ministers Resolution · No. 149 · 2 April 2022Introduction of mandatory digital labeling of medicines and medical devices
Cabinet of Ministers Resolution · No. 737 · 20 November 2020Introduction of mandatory digital labeling for selected product categories
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
Cabinet of Ministers Resolution · No. 738 · 18 September 2018Measures to further improve the system of supplying the population with pharmaceutical products
Cabinet of Ministers Resolution · No. 334 · 3 May 2018Regulation on organising the activity of social pharmacies
Presidential Resolution · No. PP-3489 · 23 January 2018Further regulation of production and import of medicines and medical devices
Cabinet of Ministers Resolution · No. 185 · 6 April 2017Implementation of the sector law — distribution, pharmacy sales and withdrawal
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
Cabinet of Ministers Resolution · No. 22 · 5 February 2014Improvement of labeling and customs clearance of selected imported consumer goods
Law of the Republic of Uzbekistan · No. 221-I · 26 April 1996On protection of consumer rights
Sanitary rules and normsSanitary rules for the design, equipment and operation of medicine and medical device storage warehouses
State standardGood Pharmacy Practice — GPP
Sanitary rules and norms · No. 0110-26SanPiN No. 0110-26: sanitary rules for the production, safety and circulation of dietary supplements

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