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EE SAM - FDA

FDA - EE SAM

STATEMENT OF AUTHORITY
AND
CONFIDENTIALITY COMMITMENT FROM
THE ESTONIAN STATE AGENCY OF MEDICINES
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 the Estonian State Agency of Medicines (EE SAM) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.

EE SAM 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. EE SAM understands that this non-public information is shared in confidence and that FDA considers it critical that EE SAM maintain the confidentiality of the information. Public disclosure of this information by EE SAM could seriously jeopardize any further scientific and regulatory interactions between FDA and EE SAM. FDA will advise EE SAM of the non-public status of the information at the time that the information is shared.

Therefore, EE SAM certifies that it:

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

Signed on behalf of EE SAM:

 

________/s/___________                                                  Date: October 25, 2012
Kristin Raudsepp
Director General

State Agency of Medicines
1 Nooruse str
50411 Tartu
ESTONIA

Telephone: +372 7 374 140
Facsimile: +372 7 374 142
info@ravimiamet.e