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Registration and dossier17 docs

Order of the Minister of Health · No. 7 · 30 April 2026Requirements for medicinal-product state-registration documents
Cabinet of Ministers Resolution · No. 738 · 24 November 2025State-registration procedures for medicines and medical devices
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
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
Order of the Minister of Health · No. 31 · 3 January 2025Regulation on state registration of certain medicines without clinical trials
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
OrderMedicine and medical-device registration fees — Center source
Pharmaceutical Safety Center guidelineGuidance on variations to medicinal-product registration documents
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
Pharmaceutical Safety Center guidelineGuidance on package leaflets and summaries of product characteristics

Quality, GxP and pharmacopoeia5 docs

Safety and post-marketing control1 docs

Order of the Minister of Health · No. 18 · 30 December 2025Pharmacovigilance and medical-device safety monitoring

Clinical trials3 docs

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 labelling22 docs

Controlled substances3 docs

Prices, procurement and reimbursement6 docs

Framework and sector reforms2 docs

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