STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE (EDQM)NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES

The United States Food and Drug Administration, an agency within the Department of Health and Human Services (FDA), is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the European Directorate for the Quality of Medicines & HealthCare (EDQM) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

EDQM understands that some of the information it receives from FDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. EDQM understands that this non-public information is shared in confidence and that FDA considers it critical that EDQM maintain the confidentiality of the information. Public disclosure of this information by EDQM could seriously jeopardize any further scientific and regulatory interactions between FDA and EDQM. FDA will advise EDQM of the non-public status of the information at the time that the information is shared.

Therefore, EDQM certifies that it: 

1. has the authority to protect from public disclosure such non-public information provided to EDQM in confidence by FDA; 
    
2. will not publicly disclose such FDA-provided non-public information without the written authorization of the owner of the information, the written authorization from the individual who is the subject of the personal privacy information, or a written statement from FDA that the information no longer has non-public status; 
    
3. will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from EDQM. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, EDQM will take all appropriate legal measures in an effort to ensure that the information will be disclosed in a manner that protects the information from public disclosure; and 
    
4. will promptly inform FDA of any changes to the Council of Europe/European Community laws, regulations, policies or procedures that would affect EDQM’s ability to honor the commitments in this document.

_______/s/______
Susanne Keitel, Ph.D.
 

Date:04/08/2009
 

Director
European Directorate for the Quality
of Medicines & HealthCare (EDQM)
COUNCIL OF EUROPE
7 allée Kastner
CS 30026
F-67081 Strasbourg
France

Phone +33 3 88 41 26 79
Fax +33 3 88 41 27 71