|Social Audit Ltd|
|P O Box 111 London NW1 8XG|
|Telephone/Fax 44 (0)171 586 7771|
|M. Patrick Deboyser, Head of Pharmaceutical|
|Products and Cosmetics Unit|
|DG-III, European Commission|
|Rue de La Loi 200|
|Brussels, Belgium 1049||
4 August 1998
Dear M. Deboyser,
As I expect you have heard from Professor Bass, I have expressed some interest in the recent EMEA opinion on antidepressant drugs. In particular, I am concerned about the new warning about withdrawal reactions recommended for inclusion in the product SPC. As you probably also know, Social Audit now operates a website journal on this and related subjects: yes, it's all a bit unorthodox but I hope you can accept it as a worthwhile experiment in responsible journalism.
Professor Bass has now advised me to contact you and, in case you have not seen them, I am enclosing a copy of correspondence with him, plus a note which outlines the background to and basis of my concerns.
I would be grateful if you could let me know if you are able, at this stage, to consider formal representations in this matter and, if so, whether you can accept the enclosed as such and/or if would like me to provide any further information relating to the documents enclosed. I would be happy to do so, or to reframe this petition to comply with relevant Commission procedures.
Could you also please let me know whether there is any formal appeal mechanism available to me, in the event of a Commission ratification of the CPMP/EMEA opinion?
Thank you for your attention and I look forward to hearing from you.
Yours sincerely, Charles Medawar
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