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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. 577 · 19 October 2026Historical versionOn introducing a system that grants medical and pharmaceutical workers the right to practise through state registrationMedicines
Presidential Decree · No. UP-191 · 10 September 2026Checked against the official sourceMedical and pharmaceutical training reform — pharmaceutical-circulation amendments in the annexMedicines
Presidential Decree · No. UP-192 · 10 September 2026Checked against the official sourceOn introducing a system of state registration of medical and pharmaceutical workersMedicines
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
Cabinet of Ministers Resolution · No. 472 · 7 September 2026Checked against the official sourceOn additional measures to improve legislation on technical regulationMedicines
Presidential Decree · No. UP-174 · 27 August 2026Checked against the official sourceImproving customs bodies and modern customs administrationMedical devices and equipmentMedicines

All documents by section

Registration and dossier29 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
Presidential Decree · No. UP-77 · 5 May 2026Improving management efficiency in the healthcare system
Order of the Minister of Health · No. 7 · 30 April 2026Requirements for medicinal-product state-registration documents
Order of the Minister of Health · No. 12 · 27 April 2026Amendments to medical-device nomenclature and risk-classification rules
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. 16 · 24 December 2025Medical-device nomenclature and risk classification
Cabinet of Ministers Resolution · No. 738 · 24 November 2025State-registration procedures for medicines and medical devices
Cabinet of Ministers Resolution · No. 720 · 13 November 2025On the administrative regulation for issuing sanitary-epidemiological conclusions on food and agricultural products
Order of the Minister of Health · No. 12 · 21 October 2025Classifiers of key medicinal-product pharmacological characteristics
Presidential Decree · No. UP-137 · 19 August 2025Additional measures regulating the circulation of medicines and medical devices
Order of the Minister of Health · No. 6 · 28 July 2025Amendments to the list of medicines and devices allowed for use and import without state registration subject to mandatory certification
Order of the Minister of Health · No. 5 · 27 February 2025List of medicines and medical equipment allowed for use and import without state registration subject to mandatory certification and lacking registered analogues
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
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
Law of the Republic of Uzbekistan · No. ZRU-908 · 15 February 2024Amendments to legislative acts aligning national legislation with WTO agreements
Cabinet of Ministers Resolution · No. 862 · 24 October 2018Recognition of overseas medicinal-product registration results — 2018 resolution
Presidential Resolution · No. PP-3948 · 24 September 2018Additional measures on registration and circulation of medicines — PP-3948
Cabinet of Ministers Resolution · No. 213 · 23 March 2018Former medicine and medical-device registration procedure — Resolution No. 213
Pharmaceutical Safety Center guidelineGuidance on medicinal-product application assessment
InstructionMedical-device registration-document requirements — Center source
Pharmaceutical Safety Center guidelineGuidance on expert assessment of registration documents
Pharmaceutical Safety Center guidelineGood Review Practice guidance — GrevP
Pharmaceutical Safety Center guidelineGuidance on package leaflets and summaries of product characteristics
OrderMedicine and medical-device registration fees — Center source
Pharmaceutical Safety Center guidelineGuidance on suspension and cancellation of registration certificates
Pharmaceutical Safety Center guidelineGuidance on variations to medicinal-product registration documents

Quality, GxP and pharmacopoeia21 docs

Order of the Minister of Health · No. 14 · 10 April 2026Procedure for setting fees for GxP pharmaceutical inspection of pharmaceutical enterprises and preclinical and clinical research sites
Order of the Minister of Health · No. 13 · 16 December 2025Certification-rule amendments covering GMP and ISO 13485 — No. 3386-2
Order of the Minister of Health · No. 14 · 12 December 2025Development and inclusion of general and individual pharmacopoeial monographs
Order of the Minister of Health · No. 15 · 12 December 2025Use of leading pharmacopoeial test methods where the State Pharmacopoeia has no provision
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
Order of the Minister of Health · No. 8 · 26 May 20252025 amendments to pharmaceutical-product certification rules — No. 3386-1
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. 502 · 14 August 2024On approval of regulations on product state registration and conformity assessment procedures
Presidential Resolution · No. PP-411 · 26 October 2022Measures to supply quality medicines and medical products — PP-411
Order of the Minister of Health · No. 16 · 27 July 2022Pharmaceutical-product certification rules
Presidential Decree · No. UP-55 · 21 January 2022Pharmaceutical-sector development measures for 2022–2026 — UP-55
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. 43 · 30 January 2021On approval of the lists of products subject to mandatory conformity confirmation
Cabinet of Ministers Resolution · No. 788 · 18 September 2019Implementation of good-practice requirements and GxP inspections
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. 112 · 15 February 2018Metrological control of laboratory and diagnostic equipment used in medicine
Cabinet of Ministers Resolution · No. 365 · 27 October 2016General technical regulation on medicinal-product safety
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 control8 docs

Presidential Decree · No. UP-25 · 16 February 2026Accelerating technical regulation reforms based on international practice
Order of the Minister of Health · No. 18 · 30 December 2025Pharmacovigilance and medical-device safety monitoring
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
Cabinet of Ministers Resolution · No. 628 · 4 October 2024Post-marketing control of pharmaceutical products
Presidential Decree · No. UP-20 · 23 January 2024Additional measures regulating the pharmaceutical sector — UP-20
State standard · No. SanPiN 0340-16 · 21 December 2016Hygienic requirements for the production and safety of perfume and cosmetic products
Law of the Republic of Uzbekistan · No. ZRU-393 · 26 August 2015On the sanitary and epidemiological welfare of the population

Clinical trials4 docs

Order of the Minister of Health · No. 28 · 24 December 2025Clinical trials of investigational pharmacological agents and medicines
Order of the Minister of Health · No. 26 · 22 December 2025Pharmacokinetic bioequivalence trials for generic medicines and evaluation of results
Order of the Minister of Health · No. 12 · 16 May 2023Former clinical-trial procedure — Justice registration No. 3439
Cabinet of Ministers Resolution · No. 181 · 14 April 2022Measures to develop clinical trials of medicines and conduct them in line with international standards

Licensing and supervision4 docs

Order of the Minister of Health · No. 24 · 26 August 2026Risk-analysis system for pharmaceutical regulatory compliance oversight
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 labelling42 docs

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
Order of the Minister of Health · No. 15 · 30 April 2026Amendments to certain departmental acts of the Ministry of Health (medical device terminology)
Presidential Resolution · No. PP-136 · 13 April 2026Measures to create favourable conditions for further development of e-commerce
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

Controlled substances15 docs

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
Presidential Resolution · No. PP-239 · 24 June 2026Additional measures to improve palliative medical care for the population
Law of the Republic of Uzbekistan · No. ZRU-1151 · 11 June 2026Amendments to certain legislative acts improving liability for illicit trafficking of narcotic drugs, psychotropic substances or their analogues and potent substances
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)
Presidential Decree · No. UP-207 · 3 November 2025Comprehensive measures to protect public health and the gene pool from drug addiction and drug crime
Order of the Minister of Health · No. 36 · 25 December 2024Approval of conditions for storage, issue, sale, distribution and accounting of narcotic drugs, psychotropic substances and precursors
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
Presidential Decree · No. UP-73 · 6 May 2024On strategic measures against illicit trafficking of narcotic and psychotropic substances
Cabinet of Ministers Resolution · No. 818 · 27 September 2019On regulating the turnover of potent substances
Presidential Resolution · No. PP-4438 · 6 September 2019Strengthening measures to prevent illicit circulation of medicines
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. 472 · 29 October 2003Regulations on the turnover of narcotic drugs, psychotropic substances and precursors
Law of the Republic of Uzbekistan · No. 813-I · 19 August 1999On narcotic drugs and psychotropic substances

Prices, procurement and reimbursement10 docs

Order of the Minister of Health · No. 18 · 23 April 2026List of diseases included in the reimbursement programme and medicines provided for their treatment
Order of the Minister of Health · No. 6 · 11 March 2026Identification of medicines with unproven or unstudied efficacy during registration
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. 662 · 21 October 2025Amendments to and repeal of certain Government resolutions (incl. pricing provisions of Resolution No. 185)
Presidential Resolution · No. PP-408 · 29 November 2024Improvement of the system for supplying medical institutions with pharmaceutical products and medical equipment
Cabinet of Ministers Resolution · No. 619 · 2 October 2024Approval of the outpatient medicine reimbursement program regulation
Cabinet of Ministers Resolution · No. 80 · 21 February 2022Electronic licensing procedure — pharmaceutical licensing passport
Law of the Republic of Uzbekistan · No. ZRU-701 · 14 July 2021Licensing, Permit and Notification Procedures Act
Presidential Resolution · No. PP-4554 · 30 December 2019Additional measures to deepen reforms in the pharmaceutical sector
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 reforms20 docs

Presidential Decree · No. UP-84 · 12 May 2026On a single state management and control system for food safety, phytosanitary and veterinary matters
Presidential Resolution · No. PP-178 · 12 May 2026On organizing the work of the Food Safety Committee
Presidential Decree · No. UP-74 · 5 May 2026Measures for additional support of the private sector in medicine
Law of the Republic of Uzbekistan · No. ZRU-1123 · 24 March 2026On physical culture and sport
Presidential Decree · No. UP-35 · 5 March 2026Additional measures supporting pharmaceutical manufacturing and research — UP-35
Order of the Minister of Health · No. 27 · 22 December 2025Clinical investigations of medical devices
Presidential Decree · No. UP-13 · 28 January 2025Additional measures to accelerate pharmaceutical-sector development — UP-13
Law of the Republic of Uzbekistan · No. ZRU-928 · 30 May 2024Amendments to certain legislative acts (incl. the Law on Medicines and Pharmaceutical Activity)
Cabinet of Ministers Resolution · No. 153 · 25 March 2024On measures to implement the Law on Technical Regulation
Presidential Decree · No. UP-36 · 16 February 2024On additional measures to ensure food security
Presidential Resolution · No. PP-14 · 10 January 2024On further development of the pharmaceutical industry and investment projects
Law of the Republic of Uzbekistan · No. ZRU-879 · 22 November 2023Amendments to certain legislative acts in connection with improving pharmaceutical activity
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-819 · 27 February 2023Law on Technical Regulation
Law of the Republic of Uzbekistan · No. ZRU-614 · 7 April 2020Law on Metrology (new edition by Law ZRU-614)
Presidential Resolution · No. PP-4574 · 28 January 2020Creation of the innovative scientific and production pharmaceutical cluster Tashkent Pharma Park
Presidential Decree · No. UP-5229 · 7 November 2017Measures to radically improve the management system of the pharmaceutical industry
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. 483-I · 30 August 1997On the quality and safety of food products
Law of the Republic of Uzbekistan · No. 415-I · 25 April 1997Medicines and Pharmaceutical Activity Act — original 1997 edition

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