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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

Cabinet of Ministers Resolution · No. 472 · 7 September 2026Checked against the official sourceOn additional measures to improve legislation on technical regulationMedicines
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
Order of the Minister of Health · No. 23 · 10 December 2025Checked against the official sourceApproval of the regulation on recording prescription medicine prices under the reference pricing systemMedicines

All documents by section

Registration and dossier6 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

Quality, GxP and pharmacopoeia7 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
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 labelling8 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

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 reimbursement1 docs

Cabinet of Ministers Resolution · No. 619 · 2 October 2024Approval of the outpatient medicine reimbursement program regulation

Framework and sector reforms5 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-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
Law of the Republic of Uzbekistan · No. ZRU-614 · 7 April 2020Law on Metrology (new edition by Law ZRU-614)

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