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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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Medical devices and equipment

Risk classes, dossiers, testing and device registration

All documents Medicines Medical devices and equipment Dietary supplements Cosmetics Sports nutrition

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All documents50 Registration and dossier14 Quality, GxP and pharmacopoeia8 Safety and post-marketing control2 Circulation, import and labelling19 Framework and sector reforms7

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List of documents for registration of medical devices and equipmentDownload · PDF 272 KB

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Latest documents

Presidential Decree · No. UP-174 · 27 August 2026Checked against the official sourceImproving customs bodies and modern customs administrationAlso in modules:Medicines
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)Also in modules:Medicines
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 documentsAlso in modules:MedicinesDietary supplementsCosmeticsSports nutrition
Presidential Resolution · No. PP-238 · 24 June 2026Checked against the official sourceImproving prevention, early detection and treatment of cancerAlso in modules:Medicines
Presidential Decree · No. UP-77 · 5 May 2026Checked against the official sourceImproving management efficiency in the healthcare systemAlso in modules:Medicines
Presidential Decree · No. UP-74 · 5 May 2026Checked against the official sourceMeasures for additional support of the private sector in medicineAlso in modules:Medicines

All documents by section

Registration and dossier12 docs

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
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)
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
Cabinet of Ministers Resolution · No. 213 · 23 March 2018Former medicine and medical-device registration procedure — Resolution No. 213
InstructionMedical-device registration-document requirements — Center source
OrderMedicine and medical-device registration fees — Center source

Quality, GxP and pharmacopoeia8 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
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. 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
Cabinet of Ministers Resolution · No. 43 · 30 January 2021On approval of the lists of products subject to mandatory conformity confirmation
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

Safety and post-marketing control2 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

Circulation, import and labelling16 docs

Order of the Minister of Health · No. 15 · 30 April 2026Amendments to certain departmental acts of the Ministry of Health (medical device terminology)
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
Cabinet of Ministers Resolution · No. 737 · 21 November 2025Measures to further improve mechanisms of public procurement of pharmaceutical products
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
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
Presidential Resolution · No. PP-203 · 30 May 2024On additional measures to accelerate mandatory digital marking
Presidential Resolution · No. PP-110 · 4 April 2023On additional measures to supply the population with quality consumer goods
Cabinet of Ministers Resolution · No. 149 · 2 April 2022Introduction of mandatory digital labeling of medicines and medical devices
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
Presidential Resolution · No. PP-3489 · 23 January 2018Further regulation of production and import of medicines and medical devices
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

Framework and sector reforms6 docs

Order of the Minister of Health · No. 27 · 22 December 2025Clinical investigations of medical devices
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-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)

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