Skip to content

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.

Knowledge base News About

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

© Pharmalex

Services

Medicine registration Medical device registration Medical equipment registration Re-registration Variations Dietary supplement registration

Company

Knowledge base News About Send a request Site map

All documents

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

Section

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

Search the knowledge base

Recently added

StatusAct typeYear

Found: 31

Latest documents

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
Order of the Minister of Health · No. 2 · 14 April 2026Checked against the official sourceProcedure for inspecting the manufacturing conditions of medical devices during state registrationMedical devices and equipmentMedicines
Order of the Minister of Health · No. 5 · 2 March 2026Checked against the official sourceAdditions to the list of orphan medicines for rare diseases and medical devices for diagnosis and treatment of rare diseasesMedical devices and equipmentMedicines
Order of the Minister of Health · No. 18 · 30 December 2025Checked against the official sourcePharmacovigilance and medical-device safety monitoringMedicinesMedical devices and equipment
Order of the Minister of Health · No. 16 · 24 December 2025Checked against the official sourceMedical-device nomenclature and risk classificationMedical devices and equipment

All documents by section

Registration and dossier9 docs

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. 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
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
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

Quality, GxP and pharmacopoeia2 docs

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. 43 · 30 January 2021On approval of the lists of products subject to mandatory conformity confirmation

Safety and post-marketing control1 docs

Presidential Decree · No. UP-25 · 16 February 2026Accelerating technical regulation reforms based on international practice

Licensing and supervision1 docs

Presidential Decree · No. UP-8 · 9 January 2024On reducing mandatory requirements and simplifying licensing and permit procedures for business

Circulation, import and labelling10 docs

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
Cabinet of Ministers Resolution · No. 149 · 2 April 2022Introduction of mandatory digital labeling of medicines and medical devices
Presidential Resolution · No. PP-3489 · 23 January 2018Further regulation of production and import of medicines and medical devices
Sanitary rules and normsSanitary rules for the design, equipment and operation of medicine and medical device storage warehouses
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
Presidential Decree · No. UP-174 · 27 August 2026Improving customs bodies and modern customs administration
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-110 · 4 April 2023On additional measures to supply the population with quality consumer goods
Law of the Republic of Uzbekistan · No. 221-I · 26 April 1996On protection of consumer rights

Framework and sector reforms2 docs

Order of the Minister of Health · No. 27 · 22 December 2025Clinical investigations of medical devices
Law of the Republic of Uzbekistan · No. ZRU-819 · 27 February 2023Law on Technical Regulation

Cards help you find a document. Check the current version on lex.uz.