HPRA (formerly IMB) - FDA
AND STATEMENT OF AUTHORITY
FROM IRISH MEDICINES BOARD
NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED
BY THE U.S. FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT
OF HEALTH AND HUMAN SERVICES
The United States Food and Drug Administration, a part of the United States Department of Health and Human Services (USFDA), is authorized under 21 C.F.R. § 20.89 ("Communications with Foreign Government Officials") to disclose non-public information to the Irish Medicines Board (IMB) regarding HHS/FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
IMB understands that some of the information it receives from HHS/FDA may include non-public information exempt from public disclosure under the laws and regulations of the United States of America, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. IMB understands that this non-public information is shared in confidence, and that HHS/FDA considers it critical that IMB maintains the confidentiality of the information. Public disclosure of this information by IMB could seriously jeopardize any further scientific and regulatory interactions between HHS/FDA and IMB. HHS/FDA will advise IMB of the non-public status of the information at the time that the information is shared.
Therefore, the IMB certifies that it:
- has the authority to protect from public disclosure the non-public information provided to IMB in confidence by HHS/FDA;
- will not publicly disclose the HHS/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 HHS/FDA that the information no longer has non-public status;
- will inform HHS/FDA within two working days of any effort made by judicial or legislative mandate to obtain HHS/FDA -provided non-public information from IMB. If such judicial or legislative mandate orders disclosure of HHS/FDA -provided non-public information, IMB 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 HHS/FDA of any changes to IMB's laws, or to any relevant policies or procedures, that would affect IMB's ability to honor the commitments in this document.
___________/s/_____________ Date: 20 Sept 2005
Mr. Pat O' Mahony
Irish Medicines Board
Kevin O'Malley House
Tel: 00 353 1 6764971
Fax. 00 353 1 661 4764