Import/Export - Biologicals

Importing Biological Products

Biological products are derived from natural resources such as humans, animals, or microorganisms, and due to the sensitive nature of these materials, it is especially important to follow detailed procedures prior to importation. Each shipment of a biological product to the United States must be supported by a separate U.S. Veterinary Biological Product Permit, and every person importing the product must hold a current authorization. If a valid permit is not presented, the product will either be destroyed, or returned to the country of origin.

The Animal and Plant Health Inspection Service (APHIS) issues three types of import permits; Research and Evaluation, Distribution and Sale, and a Transit Shipment permit. To receive a Research and Evaluation permit, the applicant must include a description of the product and of the scientific capabilities of the investigator; packaging requirements and re-import restrictions apply as well. For Distribution and Sale permits, applications must be supported by data showing that the product complies with regulations, and in order to receive the permit, the applicant must meet facility and product supervision requirements. The Transit Shipment permit is necessary for shipments going between two foreign countries by way of the United States, and requires the shipment to remain confined to the same carrier throughout the transfer. In order to receive a permit, the person seeking to import a biological product must submit an application to the APHIS that includes information on the type of permit required, the port of entry, the estimated quantity and the anticipated date of entry.

Exporting Biological Products

Requirements for exporting biological products depend on the country of destination, and in some cases, countries require Certificates of Licensing and Inspection. The Certificates of Licensing and Inspection are obtained from USDA, and ensure that the products have been registered and inspected for compliance. For licensed products, U.S. Export Certificates can be obtained from USDA/APHIS after proper forms and serials are submitted.

TSG’s regulatory experts can help with import and export issues such as obtaining Certificates of Licensing and Inspection, U.S. Export Certificates, filing permits for import, acting as a
U.S. registration agent, and other general regulatory affairs.