STATEMENT OF AUTHORITY AND CONFIDENTIALITY COMMITMENT FROM THE UNITED KINGDOM VETERINARY MEDICINES DIRECTORATE NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION
The purpose of this agreement is to strengthen communication, enhance international co-operation for the protection ofpublic health, safety, animal health and welfare, and the environment, and to facilitate the sharing ofinformation between the parties, with a view to assisting each party to improve its regulatory performance.
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 Veterinary Medicines Directorate (VMD) regarding FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
The VMD 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, such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, predecisional information. The VMD understands that this non-public information is shared in confidence and that FDA considers it critical that the VMD maintain the confidentiality ofthe information. Public disclosure of this information by the VMD could seriously jeopardize any further scientific and regulatory interactions between FDA and the VMD. FDA will advise the VMD ofthe non-public status ofthe information at the time that the information is shared.
Therefore, the VMD certifies that:
- the VMD has the authority to protect from public disclosure such non-public information provided to VMD in confidence by FDA;
- the VMD will not publicly disclose such FDA-provided non-public information withoutthewrittenauthorization ofthe owner oftheinformation,thewritten authorization from the individual who is the subject ofthe personal privacy information, or a written statement from FDA that the information no longer has non-public status;
- any non-public information received from FDA will be kept confidential and not released to any person other than members, agents or employees of the VMD who need to know the information for work purposes and who have a legally enforceable obligation, such as, but not limited to an employment contract, an agency agreement, confidentiality agreement or other document that permits those persons to use the information for the purposes of this agreement and requires them to protect the confidentiality ofthe information in accordance with the laws ofthe United Kingdom;
- the VMD will inform FDA promptly of any effort made by judicial or legislative mandate to obtain FDA-provided non-public information from the VMD. If such judicial or legislative mandate orders disclosure of FDA-provided non-public information, the VMD 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 5. the VMD will promptly inform FDA of any changes to United Kingdom's laws, or to any relevant policies or procedures, that would affect the VMD's ability to honour the commitments in this document.
Signed on behalf ofthe VMD
Acting Chief Executive
The United Kingdom Veterinary Medicines Directorate
Address: Woodham Lane
Telephone: +44 (0)1932 336911
Facsimile: +44 (0)1932 336618
Date: August 19, 2011