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;
Below is an example of a digital Certificate of Pharmaceutical Product (CPP) with the corresponding attachments. The certificate number of the CPP must match the certificate number on each page of the corresponding attachments.
The current Certificate of Pharmaceutical Product CPP digital certificates with the red ribbon and gold seal are signed by Carole Jones, Division Director of the Exports Compliance Branch, Division of Global Distribution and Policy of the Office of Drug Security, Integrity and Response.
The following are an example of the attachments which must accompany your CPP certificate. The US Department of State will not apostille your CPP without the accompany attachments. The certificate number must be included on the top left hand side of each page of the attachment.
Note: If you have received your federal documents in a digital format (PDF copy) with an electronic signature, go ahead and email it to us with the completed Washington DC order forms. If you have received your federal documents by regular mail (Hard copy), go ahead and mail it to our Washington DC office with our order forms.
Office Hours: Monday – Saturday 9am – 6pm
Customer Support: 1-800-953-3971
Email: WashingtonDC@libertyapostille.com
Download Forms: Washington DC Apostille Order Forms
Obtaining an apostille on your Certificate of Pharmaceutical Product issued by the FDA 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!
Our staff is available Monday-Saturday from 9am to 6pm to answer your questions and provide you easy to follow-step-by-step instructions. Please call us at 1-800-953-3971.
Click on the download image to your left to get started. Our apostille service is fast, convenient, and saves you time and money.
