STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY EUROPEAN DIRECTORATE FOR THE QUALITY OF MEDICINES & HEALTHCARE (EDQM)
The European Directorate for the Quality of Medicines & HealthCare (EDQM), a directorate of the Council of Europe, is authorized to disclose non-public information to the United States Food and Drug Administration, Department of Health and Human Services (FDA) regarding EDQM-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
FDA understands that some of the information it receives from EDQM may include non-public information exempt from public disclosure under the laws and regulations of the Council of Europe/European Community, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. FDA understands that this non-public information is shared in confidence and that EDQM considers it critical that FDA maintain the confidentiality of the information. Public disclosure of this information by FDA could seriously jeopardize any further scientific and regulatory interactions between EDQM and FDA. EDQM will advise FDA of the non-public status of the information at the time that the information is shared.
Therefore, FDA certifies that it:
- has the authority to protect from public disclosure such non-public information provided to FDA in confidence by EDQM;
- will not publicly disclose such EDQM-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 EDQM that the information no longer has non-public status;
- will inform EDQM promptly of any effort made by judicial or legislative mandate to obtain EDQM-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of EDQM-provided non-public information, FDA 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
- will promptly inform EDQM of any changes to U.S. laws, regulations, policies or procedures that would affect FDA’s ability to honor the commitments in this document.
Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner for International Programs
United States Food and Drug Administration
5600 Fishers Lane (HF-3)
Rockville, MD 20857