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The United States Food and Drug Administration, an agency within the Department of Health and Human Services (HHS/FDA), is authorized under 21 C.F.R. § 20.89 to disclose non-public information to the Netherlands Medicines Evaluation Board (MEB), the Netherlands Medicines Evaluation Board Agency (MEB Agency), and the Netherlands Health Care Inspectorate (IGZ) regarding HHS/FDA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
The MEB, the MEB Agency, and the IGZ understand that some of the information they receive 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. The MEB, the MEB Agency, and the IGZ understand that this non-public information is shared in confidence and that HHS/FDA considers it critical that the MEB, the MEB Agency, and the IGZ maintain the confidentiality of the information. Public disclosure of this information by the MEB, the MEB Agency, or the IGZ could seriously jeopardize any further scientific and regulatory interactions between HHS/FDA, on the one hand, and the MEB, the MEB Agency, and the IGZ, on the other hand. HHS/FDA will advise the MEB, the MEB Agency, or the IGZ of the non-public status of the information at the time that the information is shared.
Therefore, the MEB, the MEB Agency and the IGZ certify that they:
Accepted on 2 October 2006 by:
____________/s/______________
Accepted on 2 October 2006 by:
____________/s/______________ |
Accepted on 2 October 2006 by:
____________/s/_____________ |