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  1. Confidentiality Commitments

AIFA Italy - FDA, Confidentiality Commitment

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE AGENZIA ITALIANA DEL FARMACO NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED 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 Agenzia Italiana del Farmaco (AIFA) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

AIFA 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. AIFA understands that this non-public information is shared in confidence and that FDA considers it critical that AIFA maintain the confidentiality of the information. Public disclosure of this information by AIFA could seriously jeopardize any further scientific and regulatory interactions between FDA and AIFA. FDA will advise AIFA of the non-public status of the information at the time that the information is shared. When documents are shared, FDA will mark each document clearly with its non-public status.

Therefore, AIFA certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to AIFA 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 AIFA. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, AIFA 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 Italy’s laws, or to any relevant policies or procedures, that would affect AIFA’s ability to honor the commitments in this document.

___________/s/______________
Prof. Guido Rasi
Direttore Generale
Agenzia Italiana del Farmaco (AIFA)

Address: Via della Sierra Nevada 60
00144, Roma, Italy

Telephone: +3906 59784205
facsimile: +3906 59784054

Date: December 4, 2009

 
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