Veterinary diagnostics are a big business worldwide, estimated to be worth around US $4.1 billion in 2016 and projected to reach as much as $6.6 billion by 2021.
In America, the veterinary biologics industry (which includes vaccines and diagnostic test kits) is regulated by the US Department of Agriculture (USDA)’s Animal and Plant Health Inspection Service (APHIS) under the Virus-Serum-Toxin Act. This act governs the manufacturing and marketing of veterinary biologics shipped into, within, or from the U.S. to ensure that these products are pure, safe, potent and effective; this work is performed by the Center for Veterinary Biologics (CVB).
Domestic manufacturers need to have a U.S. Veterinary Biologics Establishment License and an individual U.S. Veterinary Biologics Product License for each product they sell domestically. For foreign companies looking to import their foreign manufactured veterinary products into the U.S., there are some different requirements. Most importantly, foreign manufacturers must partner with a US-based entity as their “permittee.” The permittee, which can be a company or individual, needs to have a facility in the US to receive and ship products, and also have someone present to let an inspector in without notice. The company or individual then acts on the foreign entity’s behalf with the USDA for the imported products. The US entity is the permit holder, not the foreign manufacturer, and no USDA product nor establishment license will be issued to either party. Both the US entity and foreign entity will need to be inspected by the USDA prior to a permit being issued.
Veterinary biologics manufactured abroad and sold in the U.S. through a permittee have to undergo certain quarantine, inspection and release procedures for each batch manufactured. Additionally the ability to sell an imported product in the U.S. can be affected by the country of origin’s disease and/or trade status. For example, if there is a trade embargo currently in effect between the U.S. and the country of origin, then manufacturers from that country cannot import products into the U.S., even with a proper permittee arrangement in place.
The easiest way for foreign manufacturers of veterinary biologics to start importing their products into the U.S. is to find a company who already holds a USDA facility license. This removes the necessity for the U.S. entity to be inspected prior to receiving a product permit as the facility has already undergone inspection and there is a preexisting relationship and familiarity with the USDA and their regulations. As a USDA Licensed Biologics Manufacturer, SafePath Laboratories is set up to act as a permittee for foreign manufacturers. For more information on the foreign manufacturer-permittee relationship, and how to work with SafePath as a foreign partner, please feel free to contact us.
References and further reading:
Mordor Intelligence. 2016. “Global Veterinary Diagnostics Market: Trends & Forecasts (2016-2021).” Available at https://www.mordorintelligence.com/industry-reports/global-veterinary-diagnostics-market-products-animal-types-trends-forecasts-2014-2019-industry.
USDA Animal and Plant Health Inspection Services (USDA APHIS). “Veterinary Biologics.” Available at https://www.ncbi.nlm.nih.gov/pubmed/1286752.
USDA APHIS. “Import-Export of Biological Products.” Available at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/ct_vb_import_export_products.
USDA APHIS. “Common Questions about Veterinary Biologics.” Available at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/ct_vb_pel_faqs.
USDA APHIS. 2013. “Veterinary Services Memorandum No. 800.101.” Available at https://www.aphis.usda.gov/animal_health/vet_biologics/publications/memo_800_101.pdf.