Procedure to apostille / authenticate a "Certificate of a Pharmaceutical Product - Foreign Manufacturer"

The FDA has begun issuing a "Certificate of a Pharmaceutical Product - Foreign Manufacturer" for products that are produced by a foreign manufacturer, imported and marketed in the United States, then exported to other countries.

This certificate is usually issued by the FDA on special paper with a white background, in contrast to the green background paper that the "Certificate to Foreign Government" is usually issued upon.

This is an example of a "Certificate of a Pharmaceutical Product - Foreign Manufacturer"

United States Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
Email: Telephone: (301) 796-4950

Certificate of a Pharmaceutical Product - Foreign Manufacturer

Certificate Issue Date:             xx/xx/xxxx

Certificate Expiration Date:            xx/xx/xxxx

Certificate No.                         xx-xxxx-xxxx-xx-xx Certifying Country:                       U.S.A.
  Importing Country:                       xxx
1. International or National Nonproprietary Name (if applicable) and dosage form:


1.1 Active Ingredient(s) and amount(S) per unit dose (complete quantitative composition is preferred): ..........
1.2 Is this product licensed to be placed on the market for use in the exporting country? ..........
1.3 Is this product actually on the market in the exporting country?  ..........
2A.1 Number of product-license and date of issue:     **-***      **/**/****

2B.1 Applicant for certificate (name and address)

2A.2 Product-license holder: .......... 2B.2 Status of Applicant:
2A. 3 Status of product-license holder: .......... 2B.3 Why is authorization lacking?
2A.4 Is an approved summary basis appended? .......... 2A.3.1 or 2B.2.1 Manufacturer name and address ..........
2A.5 Is the attached product information complete and consonant with the license? .......... 2B.4 Remarks:
The FDA has no specific current Knowledge of the cGMP's of this foreign manufactured product. For the current cGMP status contact the country of the manufacturer. This FDA certification pertains to the product marketed in the United States. 
Exporting Country: ..........
2A.6 Applicant for certificate if different from the license holder (name and address):
3. Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced?   ..........
3.1 Periodicity of routine inspection (years):                      
Pursuant to section 510 (h)(3) of the Federal Food, Drug, & Cosmetic Act, inspections will occur in accordance with a risk-based schedule

3.2 Has the manufacture of this type of dosage form been inspected:   ..........

3.3 Do the facilities and operations conform to GMP as recommended by the WHO? (GMP including 21 CFR parts 210, 211 or ICH  QA)           
4. Does the information submitted by the applicant satisfy the certifying authority on all aspects of the manufacture of the product undertaken by another party?                                                       

This document has a different required procedure for apostille or authentication than the usual FDA document issued on green paper with a gold seal. 
In fact, if this document is sent to the US Department of State for apostille it will be rejected. The US Department of State will send back the document with the following explanation: "The enclosed document will require certification from the Department of Health and Human Services before this office can process it." 

US Legalization offers a service to properly apostille these documents. They will certify the signer, notarize the document, certify it from the Clerk of the Court of Maryland and have it apostilled from the Secretary of State of Maryland.

Pharmaceuticals companies will be billed  $45.00 per document with a turn around time of 24 hours. 
Mailing address is: 1615 Bay Head Rd. Annapolis MD 21409

For more information, please visit the US Legalization website: 
or call (410) 349-4900 .