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New medicines, generics and biologics: from dossier to certificate.
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Equipment for clinics and laboratories, including service documents.
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We renew the registration before the certificate expires.
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Import and production permit, sanitary-epidemiological conclusion.
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Found: 11
Latest documents
Pharmaceutical Safety Center guideline
Needs review
Guidance on suspension and cancellation of registration certificates
Medicines
Order of the Minister of Health · No. 24 · 5 January 2026
Checked against the official source
Import and use of temporarily scarce medicines and devices without state registration, subject to certification
Medicines
Medical devices and equipment
Order of the Minister of Health · No. 6 · 28 July 2025
Checked against the official source
Amendments to the list of medicines and devices allowed for use and import without state registration subject to mandatory certification
Medical devices and equipment
Medicines
Order of the Minister of Health · No. 5 · 27 February 2025
Checked against the official source
List of medicines and medical equipment allowed for use and import without state registration subject to mandatory certification and lacking registered analogues
Medical devices and equipment
Medicines
Order of the Minister of Health · No. 6 · 11 March 2026
Checked against the official source
Identification of medicines with unproven or unstudied efficacy during registration
Medicines
Cabinet of Ministers Resolution · No. 738 · 24 November 2025
Checked against the official source
State-registration procedures for medicines and medical devices
Medicines
Medical devices and equipment
All documents by section
Quality, GxP and pharmacopoeia
2 docs
Order of the Minister of Health · No. 8 · 26 May 2025
2025 amendments to pharmaceutical-product certification rules — No. 3386-1
Cabinet of Ministers Resolution · No. 502 · 14 August 2024
On approval of regulations on product state registration and conformity assessment procedures
Licensing and supervision
1 docs
Cabinet of Ministers Resolution · No. 86 · 22 February 2022
On the Unified Regulation on issuing certain permits through a special electronic system
Circulation, import and labelling
1 docs
Presidential Decree · No. UP-174 · 27 August 2026
Improving customs bodies and modern customs administration
Framework and sector reforms
1 docs
Presidential Resolution · No. PP-197 · 20 June 2023
Measures for effective organisation of public administration in healthcare under administrative reforms
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