Bryan Edwards distribution manager & responsible person at Almac Pharma Services details the financial and custom considerations for bringing an orphan drug to market.
Supply chain
Adequate preparation is vital in mitigating issues that may arise in a supply chain, particularly for a high value product. Proactively considering financial and customs considerations and your entire supply chain are crucial to your commercial distribution strategy in order to ensure the most efficient and cost effective process with minimum risk.
Financial & Customs Considerations
Are you managing your Importer of Record (IoR) process?
It is highly recommended that sponsors consider the IoR process as early as possible when planning a supply chain. Imports into another customs territory cannot take place without a nominated IoR, which is a legal entity that has responsibility for ensuring the imported goods comply with local laws, filing completed customs declarations and paying the associated duties and taxes