FDA documents Apostille/Authentication

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services (HHS) responsible for protecting and promoting public health by ensuring the safety, effectiveness, and security of human and animal drugs, biological products, and medical devices; ensuring the safety of food and feed, cosmetics, and radiation-emitting products; and regulating tobacco products.

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a "certificate" for products regulated by the Food and Drug Administration (FDA). A certificate is a document prepared by FDA containing information about a product's regulatory or marketing status.

Why do foreign governments want FDA Export Certificates?

In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States or meet specific U.S. regulations, for example, current Good Manufacturing Practice (cGMP) regulations. Review of an FDA Export Certificate may be a required part of the process to register or import a product into another country.

What Types of Export Certificates does FDA issue?

At the current time, FDA issues the following types of Export Certificates:

  • Certificate of Free Sale (Certificate of Export for Seafood)

  • Health Certificates for Food/Feed

  • Specified Risk Materials of Bovine, Ovine and Caprine Origin Certificate

  • Certificate of a Pharmaceutical Product

  • Non-clinical Research Use Only Certificate

  • Certificate to Foreign Government

  • Certificate of Exportability

How to Apostille or Authenticate those documents?

Document issued by the Department of Health and Human Services FDA division can be apostilled or authenticated by the Department of State and then legalized by the embassies in the U.S. (if needed). Embassy legalization usually should be done if the destination country is NOT a member of the Hague Apostille Convention. You may also be interested in Apostille (including Hague Apostille Country List) and The ABCs of Apostilles from HCCH: How to ensure that your public documents will be recognized abroad.

Simply fill out our Order Form and mail us the original document which needs apostille or authentication.

American Notary Service Center Inc. provides fair, fast, confidential, and professional document notarization and certification services for our clients. We also provide various assistance services to small businesses led by socially and economically disadvantaged groups. Our service helps small businesses obtain federal government contracts, gain a foothold in the market, and boost their sales. For more information, please visit our website at www.usnotarycenter.com, and contact us by calling 202-599-0777 or by email at info@usnotarycenter.com.


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