Case Study: Building an importation solution enabling a Cell & Gene product be imported into EU/EEA in less than 36 hours

Challenges

• Sponsor had no direct representation in any EU/EEA state
• Logistical challenges linked to novel Cell & Gene Product limitations, temperature controlled environment with a specific very short time-frame expiry
• Custom clearance and Duty payments challenges as it was critical to ensure that clearance activities would be completed as fast as possible in a compliant manner not to waste any time
• Regulatory obligations across multiple EU/EEA jurisdictions

MIAS Pharma’s Solution

• Bringing together the right ecosystem of specialized partners across key roles including transportation, Site of Importation, Importer of Record (IoR), Customs Duty Clearance and Quality Assurance
• Designed a custom solution addressing the specific nature of the product (Cell & Gene) critical time constraints and the fact that the sponsor had no direct representation in the EU/EEA
  • Setting ley importation roles (importer, Declarant/Importer of Record and Representative)
  • Design of physical flow and financial flow linked to import into EU/EEA
  • Valuation, Tarif Heading and pro-forma invoicing process
  • Clearance instructions
  • Definition of method of payment for custom clearance and VAT
  • Completion of key Quality Compliance activities including Site of Importation duties and QP Certification

The outcome

The IMP for the client was imported within the defined time frame and following the required temperature-controlled conditions. The transport route and logistics were carefully planned and executed accordingly. MIAS Pharma and their partner defined and implemented the appropriate payment methods for customs duties and VAT, based on the agreed Incoterms. MIAS Pharma closely collaborated with multiple parties and managed a complex importation process at a global scale.