October 23 2016 0Comment
FDA Export Certificates

How to Apostille a Certificate to Foreign Government

Are you looking to get an apostille for your Certificate to Foreign Government in the State of CA?

The office of the California Secretary of State doesn’t provide apostille service for federally issued documents, and your Certificate to Foreign Government is issued by a federal agency. All FDA documents must be apostilled or authenticated by the U.S. Department of State in Washington, DC.

California Apostille provides expedited service to obtain an apostille or authentication for your Certificate to Foreign Government (CFG) within just 4 business days and the cost is $60.00 per apostille/authentication.

What is a certificate of export?

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, medical device approval, 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 for 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 Food/Feed
  • Certificate of Export for Seafood
  • Certificate of Exportability (for products not permitted to be marketed in the USA)
  • Specified Risk Materials of Bovine, Ovine or Caprine Origin Materials

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

What is a Certificate to Foreign Government CFG?

If you want to export Pharmaceutical Products, Cosmetics, Medical Devices, or even animal feed 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 U.S. 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. U.S. export companies must present an CFG certificate to be able to market their products in these countries.

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 completed request to the Center for Veterinary Medicine CVM), if you are exporting animal food or drugs.  Mail 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 at:  CVMExportCertification@fda.hhs.gov.
  1. Send your completed request to the Center for Devices and Radiological Health CDRH), if you are exporting medical devices for human use.  Mail it 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 at:  exportcert@cdrh.fda.gov.
  1. Send your completed request to the Center for Biologics Evaluation and Research CBER), if you are exporting blood products, human tissues and biological products. Mail it 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 at: CBERBECATS@fda.hhs.gov.

After you receive your certificates for FDA, they will need to be apostilled or authenticated by the U.S. Department of State.  If you are using the certificates in participating Hague countries, you certificates are then ready for use.  If you plan to use those certificates in Non-Hague participating countries, the documents will then need to be dropped off at the destination country’s Embassy, then picked up at a later date.  The steps to complete this process are:

First, the U.S. Department of State.  You have 3 choices:

  1. You’ll need an authentication by the U.S. Department of State.  If you take it there, you will have to arrive between 8 AM and 9 AM to drop off your documents.  The person at the desk will look through your documents to be sure all the correct steps were followed, then give you a receipt for your papers, and an appointment time in 2 – 3 days.  You will return at your appointment day during those same hours to pick up your authenticated document.  The fee for this service is $8 per apostille and is payable in US Dollars by check, money order or by major credit/debit cards.  The address to drop your off your documents:  Office of Authentications, 600 19th Street NW, Washington, DC  20006.
  2. Mailing your document to the U.S. Department of State requires that you complete their form DS-4194, which lists your documents and the corresponding country(s) along with basic personal information.  The total fee of $8 per certification must be paid by a money order drawn on a U.S. bank or a check made out to the U.S. Department of State.  You can mail it to:  Office of Authentications, CA/PPT/S/TO/AUT, 44132 Mercure Circle, PO Box 1206, Sterling, VA  20166-1206.
  3. A private courier can perform delivery service for you, both the drop off and the pick up, and can follow through the next step at the Embassy of the destination country.  Be sure to do your research of the private companies because the fees and experience vary widely.  California Apostille has many years of experience, and their fee is the lowest in the United States.  You would contact the courier and make arrangements with them to have your documents, apostilled/certified at the Secretary of State, then authenticated at the U.S. Department of State, and finally legalized at the destination country’s Embassy.   To contact California Apostille to use their services, you can go to their website www.california-apostille.com, contact them by phone at (323) 977-4900, or send an email to info@california-apostille.com

Second, the destination country’s Embassy.  There are 2 choices:

  1. All Embassies have different hours, fees and turnaround times.  If you plan to visit them yourself, you should contact the Embassy to find out what their hours, fees and turnaround times are.  Some can be hundreds of dollars in fees and some turnaround times can be a month or more.  Some Embassies can be mailed to get your documents legalized, and some only allow your document to be delivered to them.  You will need to consider this when making your plans to travel overseas.
  2. Private couriers can deliver and pick up your documents from the Embassies.  Usually, when you visit their website, you will find an area showing the fees and turnaround times.  They can take your document from any of the steps to be followed, up through the Embassy legalization…from certification to authentication and finally to legalization at the Embassy.  California Apostille is a thorough private company that will perform each or all steps with experience and at a low fee.  Be sure to research any private company for fees and experience.   To contact California Apostille to use their services, you can go to their website www.california-apostille.com, contact them by phone at (323) 977-4900, or send an email to info@california-apostille.com

If you want to use California Apostille to perform this service, send us an envelope that contains the following items:

  1. The original documents that need to be authenticated
  2. The payment. We charge $60 for the authentication at the U.S. Department of State and takes 3 days.  Because each Embassy charges their own fee and has varying processing times, please go to our website to find the fee for each Embassy [here].  We will accept a company check, money order or credit card.  You will need to give us the complete credit card information so we can process the payment.  If you are not sure what that information is, call or email us and we will help you.  info@california-apostille.com or (323) 977-4900.
  3. An authentication request form that contains a daytime telephone and your destination country.
  4. A prepaid addressed return airway label (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:
    • To expedite this service, please send your package to our sister company in Washington, DC who can easily visit the U.S. Department of State and the Embassy in Washington, DC

US Apostille
1330 New Hampshire Avenue NW
Suite B1
Washington, DC  20036

    • Our prices do not include the shipping fees or shipping time in our estimated turnaround time.  pFor expedited service, please make sure that you have included a prepaid addressed airway label with your package.

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