TWINNING
Twinning is a European Commission programme that provides institutional partnerships between public authorities in Ukraine and EU Member States. Objective: to establish an independent State Control Authority in the pharmaceutical sector operating in line with EU standards.
Three components of the Twinning project
Legislative harmonisation
Adaptation of Ukrainian legislation to the EU acquis in the areas of medicines, medical devices, cosmetics, blood, SoHO, and narcotic substances.
Institutional development of the new authority
Design of organisational structure, internal policies, financial model, integrity procedures, quality management system, and IT solutions.
Team development and training
Preparation of future staff through a series of trainings across 13 specialised areas.
Who Is Implementing the Project?
From Ukraine
From the EU: a consortium of Lithuania, Poland and Germany, including:
Duration: 21 months (2025–2027)
Key Areas of Activity
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Pre-clinical and clinical trials of medicinal products
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Registration of medicinal products
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Pharmacovigilance
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Inspections of the manufacture and circulation of medicinal products (GCP, GLP)
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Licensing of the import of medicinal products
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Inspections of compliance with standards (GMP / GDP)
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Laboratory quality control of blood and blood components
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Market surveillance of medical devices and cosmetic products
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Quality control of medicinal products in circulation; haemovigilance
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Licensing and control of the circulation of narcotic drugs, psychotropic substances and precursors
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Collection and testing of donor blood and blood components
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Compliance with safety and quality standards for substances of human origin (SoHO)
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Extemporaneous (individual) compounding of medicinal products in pharmacies
План імплементації
Compliance with safety and quality standards for substances of human origin (SoHO)
🧬
October 2025 – April 2027
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Extemporaneous (individual) compounding of medicinal products in pharmacies
⚗️
October 2025 – April 2027
DOWNLOAD REPORT
Collection and testing of donor blood and blood components
🩸
October 2025 – April 2027
Inspections of the manufacture and circulation of medicinal products (GCP, GLP)
🔬
October 2025 – April 2027
Inspections of compliance with standards (GMP / GDP)
✅
October 2025 – April 2027
Pharmacovigilance
⚖️
October 2025 – April 2027
Project Team
Grzegorz Cessak
President, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Poland)
bp@urpl.gov.pl
Orthwin Schulte
Head of the Medical Devices Safety Unit, Federal Ministry of Health (Germany)
124@bmg.bund.de
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