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The Medical Products Agency of Sweden (MPA) is authorized to disclose non-public information to the United States Food and Drug Administration, of the Department of Health and Human Services (HHS/FDA) regarding MPA-regulated products as part of cooperative law enforcement or cooperative regulatory activities.
HHS/FDA understands that some of the information it receives from MPA may include non-public information exempt from public disclosure under the laws and regulations of Sweden, 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 MPA 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 MPA and HHS/FDA. MPA 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 MPA's signing of a similar commitment and will remain in effect until cancelled by HHS/FDA or MPA upon 30 days' written notice.
___________/s/_____________ Date: 31 March 06 5600 Fishers Lane |