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You are here: Home / Archives for FDA Apostille

November 1, 2020 by admin

Certificate of Pharmaceutical Product CPP Apostille

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 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)

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!

ClicInternational Apostille Services Order Formsk the PDF download image to get started. Our apostille service is fast, convenient, and saves you time and money.

Filed Under: Federal Apostille Tagged With: Certificate of Pharmaceutical Product Apostille, FDA Apostille, Washington DC Apostille

November 18, 2018 by admin

FDA Apostille – Certificate of Free Sale

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

Certificates originating from the US Federal Government (FDA) can be processed through our Washington DC Apostille office.

At National Apostille, Inc., we take the guesswork out of authenticating your documents through the US Department of State – Office of Authentication 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 provide a certification relating to products regulated by the FDA.

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.

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 digital Certificate of Free Sale issued by the Food and Drug Administration (FDA).

Apostilles 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!

ClicInternational Apostille Services Order Formsk the PDF download image to get started. Our apostille service is fast, convenient, and saves you time and money.

Filed Under: Apostille, Federal Apostille Tagged With: Certificate of Free Sale Apostille, FDA Apostille, Washington DC Apostille

USA Apostille, Inc.

USA Apostille, Inc. is the leader in document Authentication, Certification, Apostille, & Embassy or Consulate Legalization.

We provide fast document authentication services through all 50 U.S. States, the Secretary of D.C., and the U.S. Department of State in Washington, D.C.

We are a registered service provider with the Secretary of State - Authentications, Apostilles, and Certificates.

Let us take this important, complicated, and time-consuming process off your hands.

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We provide Apostille services for all 50 U.S. States including the U.S. Department of State in Washington, D.C. and select Embassy / Consulate Legalization Services in Washington, D.C., Los Angeles, New York, Texas, Illinois, and Florida.

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About the Owner:

USA Apostille, Inc. is the leader in document Authentication, Certification, Apostille, & Embassy or Consulate Legalization.

We provide fast document authentication services through all 50 U.S. States, the Secretary of D.C., and the U.S. Department of State in Washington, D.C.

We are a registered service provider with the Secretary of State - Authentications, Apostilles, and Certificates.

Let us take this important, complicated, and time-consuming process off your hands.

⭐⭐⭐⭐⭐
5 Star Excellent Service

Fast Customer Service

California / Los Angeles: 323-929-5565
California / San Francisco: 415-890-5082
Washington DC: 202-894-6554
New York: 646-859-7889
Florida: 305-425-9336
Texas: 832-583-7435
Illinois: 312-819-4840
Colorado: 720-893-4095
Toll-Free: 888-810-4054

Customer Support Hours:
8am to 7pm Monday- Saturday
SUPPORT@STATEAPOSTILLE.COM

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