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The Danish Medicines Agency (DMA) is authorized to disclose non-public information to the United States Food and Drug Administration, an agency within the Department of Health and Human Services (HHS/FDA), regarding DMA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
HHS/FDA understands that some of the information it receives from DMA may include non-public information exempt from public disclosure such as confidential commercial information; trade secret information; personal privacy information; law enforcement information; or internal, pre-decisional information. HHS/FDA understands that this non-public information is shared in confidence, and that DMA considers it critical that HHS/FDA maintain the confidentiality of the information. Public disclosure of this information by HHS/FDA could seriously jeopardize any further scientific and regulatory interactions between USFDA and DMA. DMA will advise HHS/FDA of the non-public status of the information at the time that the information is shared.
Therefore, HHS/FDA certifies that it:
This commitment will become effective upon DMA’s signing of a similar commitment and will remain in effect until cancelled by DMA or HHS/FDA upon 30 days written notice. However, even following such cancellation, DMA will continue to protect from public disclosure all nonpublic information that was shared by HHS/FDA with DMA while the commitment was in effect.
___________/s/_____________ Date: 14 November 2007 |