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Shipping IMPs for Clinical Trials in Europe: Best Practices

Shipping Investigational Medicinal Products (IMPs) for clinical trials in Europe is a critical yet complex process. IMPs are unapproved drugs used in clinical trials or Early Access Programs (EAPs) for patients with unmet medical needs. Because IMPs are not approved by regulatory agencies like the FDA or EMA, shipping them across borders involves navigating a maze of customs regulations, value-added taxes (VAT), and specific local requirements. In this guide, we outline how biotechs and biopharmas can avoid common mistakes when shipping IMPs to Europe.

Shipping Investigational Medicinal Products (IMPs) for clinical trials in Europe is a critical yet complex process. IMPs, being unapproved drugs used in clinical trials or Early Access Programs (EAPs), require meticulous handling to navigate customs regulations, value-added taxes (VAT), and specific local requirements. Common mistakes in this process can lead to significant delays and increased costs. To avoid these pitfalls, it’s essential to understand and adhere to best practices, ensuring compliance and efficiency in the supply chain. For a comprehensive guide on these practices, refer to the full article.