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!

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