News & Updates

21 June 2024

Marken Regulatory Update: CBP Updates on Importing Biological Materials and H5 Avian Influenza Samples

The U.S. Customs and Border Protection (CBP), in collaboration with the Centers for Disease Control and Prevention (CDC) and the U.S. Animal and Plant Health Inspection Service (APHIS), has issued guidelines regarding the importation and transportation of H5 avian influenza virus samples. These guidelines are part of an exemption period for H5 avian influenza viruses, where the APHIS, Veterinary Services (VS), Organisms and Vectors (OV) Permitting Unit will be responsible for issuing the necessary permits.

In addition to the VS permit, a CDC import permit is required for H5 avian influenza variants known or suspected to cause human disease. For samples that are noninfectious, importers must include a noninfectious certification statement to avoid potential clearance delays.

CBP has provided useful guidance on the importation of biological materials to address the common issues of missing, conflicting, or improper documentation and packaging. The guidance covers a wide range of biological materials, including microorganisms, materials derived from living sources, genomic materials, clinical materials, biological toxins, and allergens.

Marken stays committed to supporting it clients in navigating the regulatory and trade landscape of global clinical supply chain. Please contact our team at TradeCompliance@marken.com if you have any questions.

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