Strategic Update on Clinical Trial Material Importation in South Africa
We are pleased to announce significant developments regarding our operations in South Africa, enabling Oximio SA to assume the role of Importer of Record (IoR) for all Clinical Trial Material shipments into the country. This encompasses Investigational Medicinal Products (IMPs), Named Patient Materials, medical devices, and laboratory kits.
Key Takeaways:
- Regulatory Compliance: Oximio SA will be designated in submissions to SAHPRA as the authorized IoR, thereby assuming responsibility for customs clearance and delivery to designated sites or Oximio warehouse, contingent on our agreed scope of services with the client.
- Delegated Authority Framework: We will establish a formal Letter of Delegated Authority between Oximio SA and the Sponsor, detailing the comprehensive logistical responsibilities pertaining to the Clinical Trial. This framework will effectively limit liability concerning ownership of the imported materials.
Customer Benefits:
- Streamlined Transactions: This approach minimizes transactional complexities, significantly reducing the risk of the Sponsor facing erroneous billing or potential double charges, thereby enhancing fiscal clarity.
- VAT Management: Oximio SA will handle local VAT payments, reclaim the full VAT, and will bill clients solely for the Disbursement fee based on 15% VAT of the total shipment value at the pre-agreed PTC rate.
- Centralized Communication: Acting as the sole point of contact for invoice and shipping document review and approval, Oximio SA will facilitate a more efficient shipping process, effectively mitigating delays experienced with previous shipments.
- Financial Relief for Local CROs and Sites: This arrangement alleviates the burden on local CROs and sites from having to pay VAT and duties upfront for DTS shipments, thus reducing the risk of regulatory complications at customs.
Under this new framework, all shipments will be processed under CIP (Carriage and Insurance Paid To) or DAP (Delivered at Place) incoterms:
- CIP: The seller not only covers carriage costs but also secures insurance against loss or damage during transit to the specified destination.
- DAP: The seller assumes full responsibility for the shipment until the goods are delivered to a specified location, with risk transferring to the buyer upon delivery. While the seller manages export clearance, the buyer is accountable for import customs duties, fees, and taxes.
We look forward to leveraging this new structure to enhance our service delivery and client satisfaction.
Clinical Trial Supply Chain Solutions in South Africa
To find out more about how we can support your clinical trial in South Africa, please visit our website or contact us.