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 (CPP) 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 certificate relating to products subject to the Federal Food, Drug, and Cosmetic Act. 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. A fee of up to $175 may be charged for each certificate issued. In addition to issuing export certificates for approved or licensed products, the FDA will also issue export certificates for unapproved products that meet the requirements of Sections 801(e) or 802 of the Act.

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.

Colored ribbons designate the type of CPP…
– Red for approved drug product, API, OTC marketed per
monograph, and export only drugs.
– Blue for unapproved drug product not marketed in the U.S.
– Yellow for drug manufactured outside of the U.S.

What is a CPP?
Certificate of Pharmaceutical Product (CPG 7150.01)

• Certificate to export human drug products (including
  biological drugs)
• Conforms to the World Health Organization (WHO)
  certification requirements
• Contains information about the pharmaceutical
  regulatory or marketing status in the U.S.

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 9am to 6pm to answer your questions and provide you easy to follow-step-by-step instructions.  Please call us at 1-800-850-3441.

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