STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE ITALIAN MINISTRY OF HEALTH NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE UNITED STATES FOOD AND DRUG ADMINSTRATION
The United States Food and Drug Administration (FDA) is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the Italian Ministry of Health (IMOH) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
IMOH 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. IMOH understands that this non-public information is shared in confidence and that FDA considers it critical that IMOH maintain the confidentiality of the information. Public disclosure of this information by IMOH could seriously jeopardize any further scientific and regulatory interactions between FDA and IMOH. FDA will advise IMOH of the non-public status of the information at the time the information is shared.
Therefore, IMOH certifies that it:
- has the authority to protect from public disclosure such non-public information provided to IMOH in confidence by FDA;
- will not publicly disclosure 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;
- will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from IMOH. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, IMOH will take all appropriate legal measures in an effort to ensure that the information will be disclosed in a matter that protects the information from public disclosure; and
- will promptly inform FDA of any changes to Italy's laws, or to any relevant policies or procedures that would affect IMOH's ability to honor the commitments in this document.
Signed on behalf of IMOH:
Director General of Food Hygiene and Safety and Nutrition
Lungotevere Ripa, 1
Date: June 2, 2014