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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: 52

Latest documents

Cabinet of Ministers Resolution · No. 472 · 7 September 2026Checked against the official sourceOn additional measures to improve legislation on technical regulationMedicines
Order of the Minister of Health · No. 24 · 26 August 2026Checked against the official sourceRisk-analysis system for pharmaceutical regulatory compliance oversightMedicines
Cabinet of Ministers Resolution · No. 396 · 21 July 2026Checked against the official sourceOn the regulations governing the Food Safety CommitteeDietary supplementsSports nutrition
Cabinet of Ministers Resolution · No. 359 · 2 July 2026Checked against the official sourceFurther improvement of narcotic drug and psychotropic substance circulation regulation in UzbekistanMedicines
Cabinet of Ministers Resolution · No. 337 · 26 June 2026Checked against the official sourceRegulation of precursor-related activities and continuous control in UzbekistanMedicines
Presidential Decree · No. UP-25 · 16 February 2026Checked against the official sourceAccelerating technical regulation reforms based on international practiceMedical devices and equipmentCosmetics

All documents by section

Registration and dossier7 docs

Cabinet of Ministers Resolution · No. 720 · 13 November 2025On the administrative regulation for issuing sanitary-epidemiological conclusions on food and agricultural products
Presidential Decree · No. UP-137 · 19 August 2025Additional measures regulating the circulation of medicines and medical devices
Cabinet of Ministers Resolution · No. 67 · 7 February 2025Amendments to certain Government decisions (incl. registration Regulations No. 213 and No. 862 of 2018)
Cabinet of Ministers Resolution · No. 48 · 29 January 2025On the Regulation on the Committee for Sanitary and Epidemiological Welfare and Public Health
Order of the Minister of Health · No. 31 · 3 January 2025Regulation on state registration of certain medicines without clinical trials
Presidential Resolution · No. PP-238 · 24 June 2026Improving prevention, early detection and treatment of cancer
Law of the Republic of Uzbekistan · No. ZRU-908 · 15 February 2024Amendments to legislative acts aligning national legislation with WTO agreements

Quality, GxP and pharmacopoeia8 docs

Cabinet of Ministers Resolution · No. 502 · 14 August 2024On approval of regulations on product state registration and conformity assessment procedures
Order of the Minister of Health · No. 17 · 27 March 2018Approval of the regulation on preparation, storage, quality control and documentation of medicines and medical devices
Cabinet of Ministers Resolution · No. 365 · 27 October 2016General technical regulation on medicinal-product safety
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
Cabinet of Ministers Resolution · No. 564 · 12 September 2024List of measuring instrument groups of state significance; separation of verification and state metrological control
Presidential Resolution · No. PP-411 · 26 October 2022Measures to supply quality medicines and medical products — PP-411
Cabinet of Ministers Resolution · No. 112 · 15 February 2018Metrological control of laboratory and diagnostic equipment used in medicine

Safety and post-marketing control3 docs

Presidential Decree · No. UP-20 · 23 January 2024Additional measures regulating the pharmaceutical sector — UP-20
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 supervision3 docs

Cabinet of Ministers Resolution · No. 86 · 22 February 2022On the Unified Regulation on issuing certain permits through a special electronic system
Presidential Decree · No. UP-8 · 9 January 2024On reducing mandatory requirements and simplifying licensing and permit procedures for business
Cabinet of Ministers Resolution · No. 577 · 19 October 2026On introducing a system that grants medical and pharmaceutical workers the right to practise through state registration

Circulation, import and labelling9 docs

Cabinet of Ministers Resolution · No. 478 · 3 August 2024On regulating retail trade in goods subject to mandatory digital marking
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
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. 341 · 15 December 2014Regulation on issuing permits for advertising medicines to minors
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)
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. 23 · 23 January 2026On additional measures to improve the mandatory digital marking system
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

Controlled substances5 docs

Cabinet of Ministers Resolution · No. 713 · 10 November 2025Amendment to Annex 37 to the Unified Regulation on licensing via the special electronic system (Resolution No. 80 of 21.02.2022)
Cabinet of Ministers Resolution · No. 725 · 31 October 2024Amendment and addition to the Unified Regulation on licensing via the special electronic system (narcotics, psychotropics and precursors)
Cabinet of Ministers Resolution · No. 632 · 4 October 2024Regulation on the turnover of special categories of potent substances
Cabinet of Ministers Resolution · No. 818 · 27 September 2019On regulating the turnover of potent substances
Cabinet of Ministers Resolution · No. 472 · 29 October 2003Regulations on the turnover of narcotic drugs, psychotropic substances and precursors

Prices, procurement and reimbursement4 docs

Order of the Minister of Health · No. 23 · 10 December 2025Approval of the regulation on recording prescription medicine prices under the reference pricing system
Cabinet of Ministers Resolution · No. 619 · 2 October 2024Approval of the outpatient medicine reimbursement program regulation
Cabinet of Ministers Resolution · No. 662 · 21 October 2025Amendments to and repeal of certain Government resolutions (incl. pricing provisions of Resolution No. 185)
Cabinet of Ministers Resolution · No. 204 · 22 July 2013Measures to further improve the provision of medicines to certain categories of persons on preferential terms

Framework and sector reforms7 docs

Cabinet of Ministers Resolution · No. 153 · 25 March 2024On measures to implement the Law on Technical Regulation
Law of the Republic of Uzbekistan · No. ZRU-819 · 27 February 2023Law on Technical Regulation
Presidential Decree · No. UP-74 · 5 May 2026Measures for additional support of the private sector in medicine
Presidential Decree · No. UP-35 · 5 March 2026Additional measures supporting pharmaceutical manufacturing and research — UP-35
Presidential Decree · No. UP-13 · 28 January 2025Additional measures to accelerate pharmaceutical-sector development — UP-13
Presidential Resolution · No. PP-197 · 20 June 2023Measures for effective organisation of public administration in healthcare under administrative reforms
Law of the Republic of Uzbekistan · No. ZRU-614 · 7 April 2020Law on Metrology (new edition by Law ZRU-614)

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