AESAN Spain - FDA, Confidentiality Commitment
STATEMENT OF COMPETENCE AND CONFIDENTIALITY COMMITMENT FROM THE SPANISH FOOD SAFETY AND NUTRITION AGENCY NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION PROVIDED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA), is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the Spanish Food Safety and Nutrition Agency (AESAN) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
AESAN 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, which is confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. AESAN understands that this non-public information is shared in confidence and that FDA considers it critical that AESAN maintain the confidentiality of the information. Public disclosure of this information by AESAN could seriously jeopardize any further scientific and regulatory interactions between FDA and AESAN. FDA will advise AESAN of the non-public status of the information at the time that the information is shared.
Therefore, AESAN states that:
- it has the authority to protect from public disclosure such non-public information provided to AESAN in confidence by FDA;
- it 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;
- it will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from AESAN. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, AESAN 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;
- it will promptly inform FDA of any changes to Spain’s laws, or to any relevant policies or procedures, that would affect AESAN’s ability to honor the commitments in this document; and
- this Confidentiality Commitment does not create binding obligations under international or domestic laws.
Signed on behalf of AESAN:
Ms. Pilar Farjas Abadía
The Spanish Food Safety and Nutrition Agency
Telephone: +34 3380389
Facsimile: +34 3380375
Date: 7th of March, 2013