How to Apostille a Certificate to Foreign Government

What is the meaning of FDA Export Certificates?

The Food and Drug Administration, Export certifications are documents issued by the FDA Department of Health and human Services DHHS, which contain information about the exported goods such as the regulatory component, storage and label instructions, and marketing permissions. Most of the imported regulatory bodies require the FDA export certificates to ensure the safety of the cargo and its eligibility for marketing in their countries. The US Food and Drug Administration issues the export certificate depending on the product being exported. These documents include, but not limited to:

• Certificate of Foreign Government” (CVM, CBER, CDRH)  
• Nonclinical Research Use Only Certificate
• Certificate of a Pharmaceutical Product (CDER, CBER, CVM)  
• Health Certificate for Food destined for the European Union
• Certificate of Free Sale for feed
• Certificate of Exportability (for products not permitted to be marketed in the USA)
• Specified Risk Materials of Bovine Origin Materials  

This post will handle all the related information concerning the issuance of the Certificate to Foreign Government (CFG) and for which products and how you can authenticate it for use overseas.

What is an FDA Certificate to Government CFG?

If you want to export Pharmaceutical Products, Cosmetics, Medical devices, or even animal feeds or drugs to Asia, Africa, the Middle East, or South America, you will need to submit a Certificate to Foreign Government along with your other documents in order for your product to be legally marketed in their countries. The CFG ensures that the exported product has been approved by the US FDA and legally marketed in the United States.

The import market regulators in the Middle East, North Africa, Asia and Latin America require a “ Certificate to Foreign Government, issued by the FDA” to ensure that the imported product has been approved by the FDA for sale in the United States. US export companies must present “CFG” certificate to be able to market their products in the above mentioned territories.

Certificate of Foreign Government” (CBER, CDRH, CVM)

You may request to issue a certificate to Foreign Government for your product from the FDA. Fill out the Request to issue a Certificate to Foreign Government from the FDA. However, it is the type of your exported cargo that determine the center to fill this form, continue reading for more information:

1. Send your document to the “Center for Veterinary Medicine CVM) if you are exporting an animal food or drugs.  Mail your document to the following address: 7519 Standish Place, Rockville, MD 20855. If you have any questions, call the center at: 240-402-5508, or email them: CVMExportCertification@fda.hhs.gov.

2. Send your document to the “Center for Devices and Radiological Health CDRH) if you are exporting Medical devices for human use.  Mail your document to the following address: 10903 New Hampshire Avenue, Building 66, Room 2621, Silver Spring, MD 20993-0002. If you have any questions, call the center at: 301 796-7400, or email them: exportcert@cdrh.fda.gov.

3. Send your document to the “Center for Biologics Evaluation and Research CBER) if you are exporting of blood products, human tissues and biological products. Mail your document to the following address: 10903 New Hampshire Ave. Building 71, Room G112, Silver Spring, MD 20993-0002. If you have any questions, call the center at: :240-402- 9155 , or email them: CBERBECATS@fda.hhs.gov.

• If you want to use California Apostille expedited service from us department of state, send us an envelope that contains the following items:

1. The documents that need to be authenticated
2. The payment confirmation (Credit Cards, Wire Transfer, Billing for corporations)
3. An authentication request form that contains a daytime telephone and your destination country.
4. A prepaid return airway envelope (FedEx, UPS, or DHL) with a tracking number to send the document back to you after finishing the authentication process. Send your envelope to the following address:

• If you need to obtain fast Apostille from the California Secretary of State office, send us an envelope that contains the previously mentioned items to the following address:

California Apostille

453 South Spring Street,Suite 734,

Los Angeles, CA 90013

• If your document is a photocopy or in PDF format(not an original document), call us to discuss the situation at: (323) 977-4900.
• We provide fast document Apostille in the State of California and from the US Department of State in Washington, DC for documents destined for use in the Apostille Countries. The cost is $60.00 per document, the turnaround time is (1- 4) business days.
• If you have a document that is destined for use in a Non-Hague country, we can expedite the legalization process from the embassy of the destination country in Washington DC.
• Our prices do not include the shipping fees, please make sure that you have included a prepaid airway ticket with your package.