Department of Health
MEDICINES CONTROL AGENCY
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0600
Facsimile 0171- 273 0737	.
	9 December 1998

Dear Mr Medawar,

I am writing further to my letter of 11 November to advise the outcome of the review which the MCA conducted of all relevant requests you made for information about the work of the Committee on Safety of Medicines (CSM).

You will recall that, in relation to your complaint (ref OG 98/59), Dr Munro concluded that the Agency should release either edited versions of the documents or a suitable summary, without harming the frankness and candour of its consultations with the CSM or the efficient conduct of the Agency's operations. In addition, I advised that we would review those previous requests where I refused you information about the CSM.

The result of our review is at Annex A. Against each request there is a note as to the MCA's original action and our finding and recommendation as to what action the Agency should now take. In some cases, our review recommends no further action. In other cases, provided disclosure is limited to factual and non-confidential information, our review concludes that the MCA should disclose the information.

I have asked staff at the MCA to complete the preparation of the outstanding documentation, suitably edited to remove all personal, commercial or otherwise confidential material. I have just received a fax of your letter of 8 December: our aim is to send the material to you this week.

I am sending a copy of this letter to the Office of the Parliamentary Commissioner for Administration.

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Criteria - for decision: "maintain confidentiality, except where information is clearly available (e.g. in annual reports) and disclosure would not be prejudicial to past understandings."

 A.2 Instances of members absenting themselves from meetings in 1991 and 1997 to avoid possible conflicts of interest

C.2 Details of forthcoming CSM and sub-committee meetings.

D: LETTER OF 14 MAY TO PROFESSOR RAWLINS 

 D.1 CSM's mandate in relation to Code requests

D.2 Extract of relevant minute of CSM's meeting which discussed the request of 12 March;

D.3 Any CSM/MCA consideration within the last 6 months (taken to mean since December 1997) of revisions to data sheet warnings about withdrawal reactions with SSRIs;

 D.4 If so, whether or not CSM is satisfied with them as they stand

D.5 If not, whether CSM has some substantial revision in mind

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	Contents page
	List of MCA/CSM Correspondence