Department of Health
Market Towers 1 Nine Elms Lane London SW8 5NQ
Telephone 0171-273 0600
Facsimile 0171- 273 0737 .
24 November 1998

Dear Mr Medawar,


Thank you for your letter of 17 October.

You asked for a characterisation of the current arrangements under which the CSM, or its members, are asked to advise on applications routed through the centralised procedure.

For all European centralised applications for new medicines where the UK representatives to the EU Committee on Proprietary Medicinal Products (CPMP) are Rapporteur or Co-rapporteur, the CSM reviews the assessment report prepared by the MCA at one of its regular meet-in s. The advice given by the CSM then forms part of the report from the LTK representatives to the CPMP. Details of how often the CSM gave such advice in 1997 can be found in the annual report (para 14, page 17), a copy of which I sent you in September.

When the UK representatives are neither Rapporteur nor Co-Rapporteur, the assessment reports prepared by the Rapporteur and Co-rapporteur are sent to the MCA. Depending on timescales, and following any discussion with the Chairman of CSM, the MCA then does one of two things. The MCA can ask the CSM for its views on the reports at one of its meetings. Alternatively, the MCA invites comments on the reports from a small group of experts, including the Chairman and selected members of CSM and may, on occasion, seek views externally, including from members of the panel of external experts established jointly by the MCA and CSM in 1996. In all cases, the Secretary to the CSM checks relevant interests. I attach a sample copy (suitably edited) of the letter of invitation. The expert views received are then used as guidance for the UK representatives when they formulate their comments to the Rapporteur and Co-Rapporteur.

No CSM member has been paid by the MCA for this work, although both they and external experts can request a preparation fee at the standard CSM rate. Details of such fees are set out in para 12 on page 16 of the 1997 annual report.

Experts may be invited to attend subsequent CPW discussions -about the application, or alternatively, to attend ad hoc expert groups which the EMEA may set up in order to consider an application. Members of these ad hoc groups are drawn from the list of European experts held by the EMEA. I attach a sample copy of the MCA letter from 1995 which invited selected experts to agree to be nominated as European experts.

Yours sincerely
Roy Alder
Head of Executive Support


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