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AEMPS Spain - FDA, Confidentiality Commitment

FDA - AEMPS

STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES 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 21C.F.R. § 20.89 to disclose non-public information to the Spanish Agency of Medicines and Medical Devices (AEMPS) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

AEMPS 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; designated national security information; or internal, pre-decisional information. AEMPS understands that this non-public information is shared in confidence and that FDA considers it critical that AEMPS maintain the confidentiality of the information. Public disclosure of this information by AEMPS could seriously jeopardize any further scientific and regulatory interactions between FDA and AEMPS. FDA will advise AEMPS of the non-public status of the information at the time that the information is shared.

Therefore, AEMPS certifies that it:

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

Signed on behalf of AEMPS:
 

_____________/s/____________________
Dr. Belen Crespo Sanchez-Eznarriaga
Director
Spanish Agency of Medicines and Medical Devices
Parque Empresarial Las Mercedes

Edificio 8
C/Campezo 1
28022 Madrid
SPAIN

Telephone: +34 91 8225020
Facsimile: +34 91 8225010

Date: December 10, 2013

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