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Information Centre
Medicines and Healthcare products Regulatory Agency
Market Towers, 1 Nine Elms Lane
London SW8 5NQ

29 January 2007


Dear Sirs,

Please treat the following as requests under the FOI Act. I am seeking to update the information the Agency provided in response to my letter of 16 February 2006 (your reference FOI 06/007).

1. What is the current status of the investigation for possible criminal prosecution of GlaxoSmithKline, in connection with its alleged failure to supply pharmacovigilance information to the MHRA relating to the paediatric use of Seroxat (paroxetine)?

2. When was the decision to investigate first taken, and has the Agency’s investigation yet been concluded? If so, have all relevant papers yet been forwarded to prosecuting lawyers within the DoH, and when was this done? If not, by what date would you expect to provide prospecting lawyers to be provided with the relevant information?

3. Has any decision been made either to prosecute GSK or not to do so? When was that decision made, by which organisation(s), and on what date was it publicly announced and how?

4. How many MHRA staff (including its agents) have been substantially involved in preparing the case were involved, and what has been the estimated cost to the Agency of the investigations made?

Thank you for your attention. I look forward to hearing from you.

Yours faithfully,
Charles Medawar

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