STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS OF POLAND
The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of Poland (Urzedowi Rejestracji Lekow, Produktow Leczniczych i Wyrobow Medycznych, henceforth URPLWMiPB) may disclose non-public information to the United States Food and Drug Administration (FDA) regarding URPLWMiPB-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
FDA understands that some of the information it receives from URPLWMiPB 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 URPLWMiPB 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 URPLWMiPB and FDA. URPLWMiPB 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 URPLWMiPB;
- will not publicly disclose such URPLWMiPB-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 URPLWMiPB that the information no longer has non-public status;
- will inform URPLWMiPB promptly of any effort made by judicial or legislative mandate to obtain URPLWMiPB-provided non-public information from FDA. If such judicial or legislative mandate orders disclosure of URPLWMiPB-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 URPLWMiPB 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