FDA Launches New Online System to Assist Industry with Exporting Animal Products

The U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) on June 22 announced the availability of a new online system – CVM Export Certification Application and Tracking System (CVM eCATS) – that will for the first time enable animal food, drug and device manufacturers to electronically apply for, track and receive export certificates.

FDA anticipates that the newly available electronic certificates will help facilitate exports by assisting industry in fulfilling importing country requirements for certification by CVM of CVM-regulated animal products. In addition, the new system will provide a tool for foreign governments to verify the authenticity of export certificates provided to them by industry.

Manufacturers exporting products from the United States often are asked by foreign customers or foreign governments to supply a “certificate” for products regulated by FDA. FDA’s export certification provides the agency’s official attestation concerning a product’s regulatory or marketing status, based on available information at the time the agency issues the certificate.

It is anticipated that the new system and electronic process will reduce the amount of time it takes for a manufacturer to apply for and receive export certificates. Once an application determination has been made, the industry recipient will be notified electronically and the recipient can access the export certificate at any time via the online system. The new tool also will simplify the process for applying for multiple certificates and enable foreign governments to verify the authenticity of a manufacturer’s export certificate via the website, enabling faster import processing.

Previously, manufacturers of CVM-regulated products were required to submit a paper application via mail. Once the application was received, CVM would review the application and issue the resulting export certificate back through the mail. Although CVM will continue to accept hard copy applications, CVM strongly encourages industry to utilize the new portal to apply for export certificates for faster processing and issuance of these documents. Industry applicants can create accounts and access the new portal starting today, June 22. Foreign government officials can also begin using the portal to verify certificates.

Manufacturers that have trouble completing the application or would like to submit an application in writing should contact CVMExportCertification@fda.hhs.gov. For additional questions related to the new system, users should refer to the CVM eCATS User Guide: Step-by-Step Instructions for Industry Applicants.