Updated December 11, 2020: Effective January 1, 2021, the FDA’s Center for Veterinary Medicine (CVM) will no longer issue the following certificates on unique CVM paper with a gold seal: Current Good Manufacturing Practice Certificates, Certificates to Foreign Government, Certificates of Free Sale and Certificates of Exportability. Exporters will now be able to access these certificates online and print them on their own.
In addition, as a result of renegotiation of CVM’s Memorandum of Understanding (MOU) with the World Health Organization (WHO), WHO no longer requires Certificates of a Pharmaceutical Product (CPP) to be issued on unique paper; for documents to be grommeted to these certificates; or for ribbon and gold seal to be attached to CPPs. Going forward, all CPPs will be printed on regular office paper with an image of the gold seal and ribbon. Foreign governments will be able to verify any of the above certificates by using the website link found at the bottom of the certificate.
June 22, 2020
Today the FDA’s Center for Veterinary Medicine (CVM) is announcing the launch of a new online system that will enable animal food, drug and device manufacturers to apply for, track and receive export certificates electronically for the first time. The 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. The CVM Export Certification Application and Tracking System (CVM eCATS) will also 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 are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by the FDA. The 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 FDA issues the certificate.
The new portal 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 (Until January 1, 2021, CVM will continue to print and mail the Certificate of a Pharmaceutical Product (CPP) to industry). This new tool will also 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. The new portal will also help the FDA to efficiently review the applications in a paper-less environment and better track applications and export certificates that have been issued.
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, users should refer to the CVM eCATS User Guide: Step-by-Step Instructions for Industry Applicants.
For more information:
- CVM eCATS
- FDA In Brief: FDA Launches New Export Certification Application System for Animal Products
- CVM eCATS User Guide: Step-by-Step Instructions for Industry Applicants
- FAQs for CVM Export Certification Application
- General Information for Consideration Prior to Applying for Certificates Using Center for Veterinary Medicine (CVM) Export Certification Application and Tracking System (CVM eCATS)
- Exporting Animal Products from the United States
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.