SIDC - FDA
STATEMENT OF AUTHORITY
THE CZECH REPUBLIC’S STATE INSTITUTE FOR DRUG CONTROL
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
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 Czech Republic’s State Institute for Drug Control (SIDC) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
SIDC 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. SIDC understands that this non-public information is shared in confidence and that FDA considers it critical that SIDC maintain the confidentiality of the information. Public disclosure of this information by SIDC could seriously jeopardize any further scientific and regulatory interactions between FDA and SIDC. FDA will advise SIDC of the non-public status of the information at the time that the information is shared.
Personal privacy information shall be shared by SIDC to FDA solely with previous written authorization from the individual who is the subject of the personal privacy information.
Therefore, SIDC certifies that it:
- has the authority to protect from public disclosure such non-public information provided to SIDC in confidence by FDA;
- 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;
- will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from SIDC. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, SIDC 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
- will promptly inform FDA of any changes to the Czech Republic’s laws, or to any relevant policies or procedures, that would affect SIDC’s ability to honor the commitments in this document.
Signed on behalf of SIDC:
____________/s/______________ Sept 17, 2012
MUDr. Pavel Březovský, MBA Date
State Institute for Drug Control
100 41 Praha 10
Telephone: +420 272 185 806
Facsimile: +420 271 732 377