Ukraine Pharma Reform 2027: What International Pharma Companies Must Do Now

Деталі:

• 
  Дата: 2 July 2026
• 
  Час: 15:00–18:00 (Kyiv) / 14:00–17:00 (CET)
• 
  Місце проведення: Online (expert presentations followed by Q&A)
• 
  Мова семінару: English
• 
  Спікери:

  • Borys Danevych, Partner, Global Co-Head and CEE Head of Life Sciences & Healthcare, CMS https://cms.law/en/ukr/people/Borys-Danevych
  • Maksym Bagrieiev, CEE, Cratia https://cratia.ua/en/maxim-bagrieiev/
• 
  Вартість:

  • Participation is free of charge for clients of Cratia and CMS
  • For other companies: EUR 200 per participant

У програмі:

1. Implementation timeline of the new Law, including key milestones, deferred provisions and transitional arrangements for currently authorised medicinal products
2. The Ukrainian Pharmaceutical Agency and its role in marketing authorisation, quality control, GxP compliance, licensing and pharmacovigilance
3. Evolving Marketing Authorisation Holder (MAH) models and restrictions, including implications for non-resident structures
4. Regulatory representation of the MAH and interaction with authorities, including digitalisation
5. Changes to marketing authorisation procedures and lifecycle management, including dossiers, labelling and packaging
6. Supply chain, import and distribution requirements, including new compliance responsibilities
7. Quality control, batch release and inspection framework, and enforcement considerations
8. Serialisation and verification system developments
9. Pharmacovigilance transformation, including the shift from audits to inspections
10. Impact of the law on advertising, promotion, HTA, reimbursement and public procurement

ЗАПИСАТИСЬ