FOI release

unredacted AR to the MPA

This request was refused in full, so we didn't provide the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00390

Received 13 April 2026

Published 11 May 2026

Request

This is an indirect FOI request, done on behalf of the Swedish Medical Products Agency, MPA. I am in no way impersonating an official at the Agency, and this private initiative should only be construed as an effort to help the MPA to finally get the missing information in this important matter. In the year 2011 Sweden, as Co-rapporteur regarding the approval av Prozac/Fontex for children, should have received the Non-Clinical Assessment Report of Prozac from the MHRA, so that the MPA could give its comments to it before finalization. The MPA never got this AR, from September 2011, and did not then get the opportunity to comment on it. The MPA has informed me that now, 15 years later, they got the attached redacted version of the report. And we come to this: I now request that the MHRA releases the unredacted AR to the MPA (the report that should have arrived 15 years ago). Even if the MPA doesn't have a chance to now give its comments and fulfil its obligations as Co-rapporteur, the Agency finally will gain access to the original unredacted report. I would appreciate a confirmation that the report has been sent to the MPA.

Response

See attached

Documents

• FOI2026_00390 (redacted).pdf (621.7 KB)

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