Customs Services
In international clinical trials, the import of investigational products and the shipment of biological samples abroad are processes requiring specific expertise. Ethic-CRO Medical Research manages these processes in line with applicable regulations.
Scope
- Import authorisation applications for investigational and auxiliary medicinal products
- Obtaining the permits required for controlled products
- Management of authorisation processes for shipment of biological samples abroad
- Follow-up of customs declaration preparation and coordination with customs brokers
- Return and destruction procedures for unused investigational products
Process management
Required documents are prepared and submitted to the relevant authorities before shipment. Applications are planned in line with the shipment schedule in order to reduce waiting times at customs. For shipments requiring cold chain, temperature records are tracked throughout the customs process.
Documentation
All authorisation correspondence, declarations and shipment documents are retained in the trial master file, so that complete records can be presented during monitoring and inspection.