STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE MAIN PHARMACEUTICAL INSPECTORATE OF POLAND
The Main Pharmaceutical Inspectorate of Poland (Główny Inspektorat Farmaceutyczny, henceforth GIF) may disclose non-public information to the United States Food and Drug Administration (FDA) regarding GIF-conducted GMP inspections as part of cooperative law enforcement or cooperative regulatory activities.
FDA understands that some of the information it receives from GIF may include non-public information exempt from public disclosure under the laws and regulations of Poland, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. FDA understands that this non-public information is shared in confidence and that GIF considers it necessary that FDA maintain the confidentiality of the information. Public disclosure of this information by FDA could seriously jeopardize any further scientific and regulatory interactions between GIF and FDA. GIF will advise FDA of the non-public status of the information at the time that the information is shared.
Therefore, FDA certifies that it:
- has the authority to protect from public disclosure such non-public information provided to FDA in confidence by GIF;
- will not publicly disclose such GIF-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 GIF that the information no longer has non-public status;
- will inform GIF promptly of any effort made by judicial or legislative mandate to obtain GIF-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of GIF-provided non-public information, 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
- will promptly inform GIF of any changes to the United States of America’s laws, or to any relevant policies or procedures, that would affect FDA’s ability to honor the commitments in this document.
Signed on behalf of FDA:
Deborah M. Autor, Esq.
Deputy Commissioner for
Global Regulatory Operations and Policy
The United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
United States of America
Telephone: +1 (301) 796 8400
Facsimile: +1 (301) 595 7937
Date: 19 April 2013