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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. 337 · 26 June 2026Checked against the official sourceRegulation of precursor-related activities and continuous control in UzbekistanMedicines
Law of the Republic of Uzbekistan · No. ZRU-1151 · 11 June 2026Checked against the official sourceAmendments to certain legislative acts improving liability for illicit trafficking of narcotic drugs, psychotropic substances or their analogues and potent substancesMedicines
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
Law of the Republic of Uzbekistan · No. ZRU-1120 · 6 March 2026Checked against the official sourceAmendments to certain legislative acts (incl. stricter liability for breaching prescription retail rules)Medicines
Presidential Decree · No. UP-67 · 18 April 2025Checked against the official sourceOn stimulating production, export and business activityCosmeticsDietary supplementsSports nutrition
Law of the Republic of Uzbekistan · No. ZRU-928 · 30 May 2024Checked against the official sourceAmendments to certain legislative acts (incl. the Law on Medicines and Pharmaceutical Activity)Medicines

All documents by section

Registration and dossier9 docs

Law of the Republic of Uzbekistan · No. ZRU-908 · 15 February 2024Amendments to legislative acts aligning national legislation with WTO agreements
Order of the Minister of Health · No. 2 · 14 April 2026Procedure for inspecting the manufacturing conditions of medical devices during state registration
Order of the Minister of Health · No. 12 · 21 October 2025Classifiers of key medicinal-product pharmacological characteristics
Order of the Minister of Health · No. 31 · 6 September 2024On reviewing applications of foreign manufacturers of medicines, medical devices and equipment and approving fees for issuing, amending, extending, re-issuing and duplicating the certificate
Presidential Resolution · No. PP-238 · 24 June 2026Improving prevention, early detection and treatment of cancer
Pharmaceutical Safety Center guidelineGood Review Practice guidance — GrevP
Pharmaceutical Safety Center guidelineGuidance on package leaflets and summaries of product characteristics
Cabinet of Ministers Resolution · No. 862 · 24 October 2018Recognition of overseas medicinal-product registration results — 2018 resolution
OrderMedicine and medical-device registration fees — Center source

Quality, GxP and pharmacopoeia8 docs

Cabinet of Ministers Resolution · No. 486 · 3 August 2021Additional measures to implement good practice (GxP) requirements in the pharmaceutical industry
Cabinet of Ministers Resolution · No. 788 · 18 September 2019Implementation of good-practice requirements and GxP inspections
Cabinet of Ministers Resolution · No. 472 · 7 September 2026On additional measures to improve legislation on technical regulation
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
State standardNational Good Clinical Practice standard — Center source
State standardNational Good Distribution Practice standard — Center source
State standardNational Good Manufacturing Practice standard — Center source

Safety and post-marketing control3 docs

Presidential Decree · No. UP-25 · 16 February 2026Accelerating technical regulation reforms based on international practice
Law of the Republic of Uzbekistan · No. ZRU-393 · 26 August 2015On the sanitary and epidemiological welfare of the population
State standard · No. SanPiN 0340-16 · 21 December 2016Hygienic requirements for the production and safety of perfume and cosmetic products

Licensing and supervision2 docs

Order of the Minister of Health · No. 24 · 26 August 2026Risk-analysis system for pharmaceutical regulatory compliance oversight
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 labelling12 docs

Cabinet of Ministers Resolution · No. 334 · 3 May 2018Regulation on organising the activity of social pharmacies
Law of the Republic of Uzbekistan · No. ZRU-1173 · 10 September 2026On amendments and additions to certain legislative acts of the Republic of Uzbekistan aimed at improving e-commerce
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. 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. 737 · 21 November 2025Measures to further improve mechanisms of public procurement of pharmaceutical products
Cabinet of Ministers Resolution · No. 570 · 8 September 2025Additional measures to accelerate digitalization of the healthcare system
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. 737 · 20 November 2020Introduction of mandatory digital labeling for selected product categories
Cabinet of Ministers Resolution · No. 738 · 18 September 2018Measures to further improve the system of supplying the population with pharmaceutical products
State standardGood Pharmacy Practice — GPP
Sanitary rules and normsSanitary rules for the design, equipment and operation of medicine and medical device storage warehouses
Sanitary rules and norms · No. 0110-26SanPiN No. 0110-26: sanitary rules for the production, safety and circulation of dietary supplements

Controlled substances1 docs

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)

Prices, procurement and reimbursement3 docs

Law of the Republic of Uzbekistan · No. ZRU-701 · 14 July 2021Licensing, Permit and Notification Procedures Act
Cabinet of Ministers Resolution · No. 80 · 21 February 2022Electronic licensing procedure — pharmaceutical licensing passport
Presidential Resolution · No. PP-4554 · 30 December 2019Additional measures to deepen reforms in the pharmaceutical sector

Framework and sector reforms8 docs

Law of the Republic of Uzbekistan · No. ZRU-879 · 22 November 2023Amendments to certain legislative acts in connection with improving pharmaceutical activity
Law of the Republic of Uzbekistan · No. ZRU-399 · 4 January 2016Amendment Act No. ZRU-399 — new edition of the Medicines and Pharmaceutical Activity Act
Law of the Republic of Uzbekistan · No. 415-I · 25 April 1997Medicines and Pharmaceutical Activity Act — original 1997 edition
Presidential Decree · No. UP-35 · 5 March 2026Additional measures supporting pharmaceutical manufacturing and research — UP-35
Presidential Resolution · No. PP-178 · 12 May 2026On organizing the work of the Food Safety Committee
Presidential Decree · No. UP-13 · 28 January 2025Additional measures to accelerate pharmaceutical-sector development — UP-13
Cabinet of Ministers Resolution · No. 153 · 25 March 2024On measures to implement the Law on Technical Regulation
Presidential Resolution · No. PP-14 · 10 January 2024On further development of the pharmaceutical industry and investment projects

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