MHRA UK - FDA, Confidentiality Commitment
STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED KINGDOM MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY 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 United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) regarding FDA-regulated products containing nicotine and/or tobacco as part of cooperative law enforcement or cooperative regulatory activities.
MHRA 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; or internal, pre-decisional information; national security information. MHRA understands that this non-public information is shared in confidence and that FDA considers it critical that MHRA maintain the confidentiality of the information. Public disclosure of this information by MHRA could seriously jeopardize any further scientific and regulatory interactions between FDA and MHRA. FDA will advise MHRA of the non-public status of the information at the time that the information is shared.
Therefore, MHRA certifies that it:
- has the authority to protect from public disclosure such non-public information provided to MHRA 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 MHRA. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, MHRA 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 United Kingdom's laws, or to any relevant policies or procedures, that would affect MHRA's ability to honor the commitments in this document.
Signed on behalf of MHRA:
Dr. Ian Hudson
Medicines and Healthcare Products
Regulatory Agency (MHRA)
151 Buckingham Palace Road
Date: December 10, 2013