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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: 29

Latest documents

Presidential Decree · No. UP-191 · 10 September 2026Checked against the official sourceMedical and pharmaceutical training reform — pharmaceutical-circulation amendments in the annexMedicines
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)Medical devices and equipmentMedicines
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
Order of the Minister of Health · No. 12 · 27 April 2026Checked against the official sourceAmendments to medical-device nomenclature and risk-classification rulesMedical devices and equipment
Cabinet of Ministers Resolution · No. 154 · 9 April 2026Checked against the official sourceOn amendments to and repeal of certain Government resolutions (April 2026)Dietary supplements

All documents by section

Registration and dossier5 docs

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
Cabinet of Ministers Resolution · No. 67 · 7 February 2025Amendments to certain Government decisions (incl. registration Regulations No. 213 and No. 862 of 2018)
Law of the Republic of Uzbekistan · No. ZRU-908 · 15 February 2024Amendments to legislative acts aligning national legislation with WTO agreements
Presidential Resolution · No. PP-238 · 24 June 2026Improving prevention, early detection and treatment of cancer
Order of the Minister of Health · No. 16 · 24 December 2025Medical-device nomenclature and risk classification

Quality, GxP and pharmacopoeia5 docs

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. 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
Order of the Minister of Health · No. 16 · 27 July 2022Pharmaceutical-product certification rules

Safety and post-marketing control2 docs

Cabinet of Ministers Resolution · No. 553 · 2 September 2025On amendments to and repeal of certain Government resolutions (September 2025)
Presidential Decree · No. UP-20 · 23 January 2024Additional measures regulating the pharmaceutical sector — UP-20

Licensing and supervision1 docs

Cabinet of Ministers Resolution · No. 847 · 18 December 2024On amendments to certain Government resolutions (December 2024)

Circulation, import and labelling4 docs

Law of the Republic of Uzbekistan · No. ZRU-1120 · 6 March 2026Amendments to certain legislative acts (incl. stricter liability for breaching prescription retail rules)
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
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
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

Controlled substances2 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)

Prices, procurement and reimbursement1 docs

Cabinet of Ministers Resolution · No. 662 · 21 October 2025Amendments to and repeal of certain Government resolutions (incl. pricing provisions of Resolution No. 185)

Framework and sector reforms3 docs

Law of the Republic of Uzbekistan · No. ZRU-928 · 30 May 2024Amendments to certain legislative acts (incl. the Law on Medicines and Pharmaceutical Activity)
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

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