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FDA Certificates Apostille/Authentication

Updated: May 5, 2023

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 to a Foreign Government (CFG)

  • Certificate of Exportability (COE)

  • Certificate of Free Sale (CFS)

  • Certificate for Cosmetics

  • Non-Clinical Research Use Only (NCR) Certificate

  • Certificate of Pharmaceutical Product (CPP)

  • Electronic Certificates of Pharmaceutical Product (eCPP)

  • Current Good Manufacturing Practice (CGMP) Declarations

  • Non-Clinical Research Use Only Certificate (NCR Certificate)

FDA Certificate Sample | fda.gv

How to Apostille or Authenticate those documents?


Document issued by the Department of Health and Human Services FDA division in the United States needs to be apostilled or authenticated before its use in other countries outside the United States.


Requirements for your FDA Certificates

  • Must be original

  • Must be on agency letterhead

  • Must include a legible signature of the official's name, printed name and title, and seal of the agency

The apostille or authentication process for you is quite simple. Simply place an order below according to your situation and mail us the original document which needs apostille or authentication.


▶️ If the destination country is a member of the Hague Convention of 1961, it needs to get the Apostille from the Secretary of State. Once the apostille is completed, It is ready for use.


▶️ However, if the destination country is NOT a member of the Hague Convention of 1961, more steps are needed. Specifically, the document needs to be authenticated by the U.S. Department of State, and the embassy of that destination country which is located in Washington D.C.


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Once we receive your order and document, it'll be processed as soon as possible.


 

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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