FDA Apostille

February 7, 2021 by admin

Do you need to apostille a document from the FDA?

Documents issued from the FDA can be processed through our Washington DC office.

We can apostille the following documents issued by the U.S. Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS):

Certificate of Free Sale
Certificate of Origin
Certificate of Pharmaceutical Product
Certificate to Foreign Governments
Certificate of Export

Documents issued by the U.S. Federal Government are not processed through the Secretary of State. They are processed through the U.S. Department of State Apostille – Office of Authentications in Washington, D.C.

Office Hours: 8am – 7pm Monday – Saturday
Customer Support: 1-800-903-2470
Email: WashingtonDC@nationalapostille.com

Here is an example of a Certificate to Foreign Government (CFG) issued by the US Food and Drug Administration (FDA):

Obtaining an apostille can be complicated. Don’t leave this process to untrained employees or non-professionals who do not fully understand the Apostille process and the unique requirements of certain countries. Your paperwork could be rejected costing you time and money. Don’t let this happen to you!

Our staff is available Monday-Saturday from 8am to 7pm to answer your questions and provide you easy to follow-step-by-step instructions. Please call us at 1-800-903-2470 or email: support@nationalapostille.com

Click the PDF download image to get started. Our apostille service is fast, convenient, and saves you time and money.

FDA Certificate of Pharmaceutical Product Apostille

November 1, 2020 by admin

Do you need an apostille on a Certificate to Pharmaceutical Product (CPP)?

The United States Food and drug Administration (FDA) issues Certificate of Pharmaceutical Product certificates that can be used in countries who are members of the Hague Apostille Convention. This certificate conforms to the format recommended by the World Health Organization.

Firms exporting products from the U.S. are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Federal Food, Drug, and Cosmetic Act and other acts the Food and Drug Administration (FDA) administers. Under the FDA Export Reform and Enhancement Act of 1996 (the Act), FDA is authorized to issue certificates for drugs, animal drugs, and devices within 20 days of receipt of a request for such a certificate.

The “Certificate of a Pharmaceutical Product” conforms to the format established by the World Health Organization (WHO) and is intended for use by the importing country when the product in question is under consideration for a product license that will authorize its importation and sale or for renewal, extension, amending or reviewing a license.

The U.S. Food and Drug Administration (U.S. FDA) of the United States of America (USA), attach different colored Ribbons to the CPP, which mark the content details. They differentiate between three different types of CPPs for:

Finished medicinal products that are legally marketable in the US authorized by the U.S FDA; A Red Ribbon will be affixed to all (regular) CPPs issued for authorized medicinal products;

Finished medicinal products which are not authorized by U.S. FDA but which may be legally exported; A Blue Ribbon will be affixed to CPPs issued only for export of an unapproved medicinal products; and a CPP for Foreign Manufacturer (products manufactured outside of the U.S.).

A Yellow Ribbon will be affixed to CPPs with foreign manufacturing sites outside of the USA. (Famulare & U.S. FDA, 2003)

Washington DC Apostille Office
Office Hours: 8am – 7pm Monday – Saturday
Customer Support: 1-800-903-2470
Email: WashingtonDC@nationalapostille.com

Click the PDF download image to get started. Our apostille service is fast, convenient, and saves you time and money.

Certificate to Foreign Government CFG Apostille

December 9, 2018 by admin

Do you need an apostille for a Certificate to Foreign Government (CFG) issued by the FDA?

The “Certificate to Foreign Government” is for the export of human drugs and biologic, animal drugs, and devices that can be legally marketed in the United States.

If you are planning to export products to another country, the government receiving the products will request a Certificate to Foreign Government which assures that the product are in compliance with U.S. laws or meets specific U.S. regulations. The Food and Drug Administration (FDA) is the government agency which issues this type of certification.

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 (GMP) regulations. Review of an FDA Export Certificate may be a required part of the process to register or import a product into another country.

Our office in Washington, D.C. specializes in authenticating FDA documents through the U.S. Department of State. Our current processing time is four business days. We also provide UPS/FedEx overnight return shipping within the USA at no additional cost. There are currently over 115 countries who are members of the Hague Apostille Convention. We routinely provide U.S. Department of State certification and Embassy/Consulate legalization for countries who are not members of the Hague Apostille Convention.

Here is an example of a Certificate to Foreign Government issued from the FDA:

Obtaining an apostille on your documents can be complicated and time consuming. Don’t leave this process to untrained employees or non-professionals who do not fully understand the Apostille process and the unique requirements of certain countries. Your paperwork could be rejected costing you time and money. Don’t let this happen to you!

Click the PDF download image to get started. Our apostille service is fast, convenient, and saves you time and money.

Certificate of Free Sale FDA Apostille

September 8, 2018 by admin

Do you need an apostille on your Certificate of Free Sale issued from the FDA?

At National Apostille, Inc., we take the guesswork out of authenticating your documents through the US Department of State in Washington DC. Our trained and knowledgeable staff are available Monday – Saturday from 8am to 7pm to answer your questions and provide you easy to follow step by step instructions.

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a certification relating to products regulated by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

A digital Certificate to Free Sale is an certificate issued by the Food and Drug Administration (FDA). This document assures that the materials listed are on file with the Food and Drug Administration, Department of Health and Human Services.

A food may be exported if it meets the specification of section 801(e) of the FD&C Act [21 U.S.C. 381(e)]. In accordance with the provisions of this section, a food intended for export shall not be deemed to be adulterated or misbranded under the FD&C Act if it:
(a) accords to the specifications of the foreign purchaser
(b) is not in conflict with the laws of the country to which it is intended for export,
(c) is labeled on the outside of the shipping package that it is intended for export, and
(d) is not sold or offered for sale in domestic commerce.

Document issued by the Department of Health and Human Services FDA division can be apostilled through our Washington, D.C. apostille office. Documents received at our offices are submitted directly to the U.S. Department of State – Office of Authentications the following business morning. The current processing time is four business days. We also provide FedEx/UPS overnight return shipping at no additional cost.

Below is an example of a Certificate of Free Sale issued by the Food and Drug Administration (FDA).