STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE MAIN PHARMACEUTICAL INSPECTORATE OF POLAND 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 Main Pharmaceutical Inspectorate of Poland (Główny Inspektorat Farmaceutyczny, henceforth GIF) regarding FDA-conducted GMP inspections as part of cooperative law enforcement or cooperative regulatory activities.
GIF 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. GIF understands that this non-public information is shared in confidence and that FDA considers it critical that GIF maintain the confidentiality of the information. Public disclosure of this information by GIF could seriously jeopardize any further scientific and regulatory interactions between FDA and GIF. FDA will advise GIF of the non-public status of the information at the time that the information is shared.
Therefore, GIF certifies that it:
- has the authority to protect from public disclosure such non-public information provided to GIF 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 GIF. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, GIF 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 Poland’s laws, or to any relevant policies or procedures, that would affect GIF’s ability to honor the commitments in this document.
Signed on behalf of GIF:
Main Pharmaceutical Inspector
Main Pharmaceutical Inspectorate
38/40 Długa Str.,
00-238 Warsaw, Poland
Tel.: +48 22 831 21 31
Fax: +48 22 831 02 44
Date: 26 April 2013