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U.S. Department of Health and Human Services

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FDA - AEMPS

AEMPS - FDA

STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT FROM
THE UNITED STATES FOOD AND DRUG ADMINISTRATION
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
BY
THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES

The Spanish Agency of Medicines and Medical Devices (AEMPS), within the legal framework (Law 29/2006, of 26th of July, on guarantees and rational use of medicinal products and health products, and Royal Decree 1275/2011, of 16th of September, by which the State Agency is created “Spanish Agency of Medicines and Medical Devices” and approval of its Statute), is authorized to disclose non-public information to the United States Food and Drug Administration (FDA) regarding AEMPS-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

The FDA understands that some of the information it receives from AEMPS may include non-public information exempt from public disclosure under the laws and regulations of Spain, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; designated national security information; or internal, pre-decisional information. The FDA understands that this non-public information is shared in confidence and that AEMPS considers it critical that the FDA maintain the confidentiality of the information. Public disclosure of this information by the FDA could seriously jeopardize any further scientific and regulatory interactions between AEMPS and the FDA. AEMPS will advise the FDA of the non-public status of the information at the time that the information is shared.

Therefore, the FDA certifies that it:

  1. has the authority to protect from public disclosure such non-public information provided to the FDA in confidence by AEMPS;
     
  2. will not publicly disclose such AEMPS-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 AEMPS that the information no longer has non-public status;
     
  3. will inform AEMPS promptly of any effort made by judicial or legislative mandate to obtain AEMPS-provided non-public information from the FDA. If such judicial or legislative mandate orders disclosure of AEMPS-provided non-public information, the 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
     
  4. will promptly inform AEMPS of any changes to the United States of America’s laws, or to any relevant policies or procedures, that would affect the FDA’s ability to honor the commitments in this document.
     

Signed on behalf of the FDA:

___________/s/______________           December 18, 2013
John M. Taylor, III, Esq.                               Date
Acting Deputy Commissioner
Global Regulatory Operations and Policy

The United States Food and Drug Administration
10903 New Hampshire Avenue
Building 31
Silver Spring, MD 20993
United States of America

Telephone: +1 (301) 796 8400
Facsimile: +1 (301) 595 7937