CENSORSHIP OF CSM MINUTES
The MCA/CSM's Appendix 3 below gives some indication of the amount of material likely to be censored when minutes of Committee on Safety of Medicines meetings are eventually posted on the Internet. No attempt has been made to isolate and delete confidential information from large blocks of text. Of the 209 pages of CSM minutes requested, 29 pages were summarised and censored and 180 pages (86%) were withheld.
CSM and sub-committee minutes edited to remove confidential information (up to 20 March 1998)
The minutes of meetings of the CSM and its sub-committees up to 20 March 1998 have been edited in summary form to remove all personal. commercial or otherwise confidential material.
A list of these meetings is below, together with a note for each meeting of the total volume of material in the minutes, the amount summarised and disclosed and the amount withheld.
The papers withheld are copies of the subsequent advice and letters which the Secretariat sends out (either to the reference member state in the case of a centralised or mutual recognition application or to the applicant in the case of a national application), notifying them of CSMs decision and/or views. These have been withheld on the grounds of exemptions 2 and 13 of Part 11 of the Code of Practice on Access to Government Information. They contain confidential material the release of which would hann the deliberative process and/or the competitive position of a third party and would compromise the effectiveness of the Agency's operations.
Committee on Safety of Medicines
1. 14 January (55 pages in total; pages 1-7 summarised. Pages 8 - 55 withheld)
2. 29 January (29 pages in total: pages 1-6 summarised. Pages 7 - 29 withheld)
3. 11 February (55 pages in total: pages 1-11 summarised. Pages 12 - 55 withheld)
4. 26 February (68 pages in total: pages 1-5 summarised. Pages 6 - 68 withheld)
5. 11 March - this meeting was cancelled
Sub-Committee on Chemistry, Pharmacy and Standards
6. 8 January (24 pages in total; pages 1 - 3 summarised. Pages 4 - 24 withheld)
7. 5 February (41 pages in total: pages 1 - 4 summarised. Pages 5 - 41 withheld)
8. 8 March (30 pages in total: pages 1 - 4 summarised. Pages 5 - 30 withheld)
Sub-Committee on Biologicals
9. 26 January (22 pages in total; pages 1 - 2 summarised. Pages 3 - 22 withheld)
10. 4 March (18 pages in total: pages 1 - 3 summarised. Pages 4 - 18 withheld)
Sub-Committee on Pharmacovigilance
11. 24 February (8 pages in total. pages 1 - 8 summarised)
NB : Paper 1 for this meeting (para 3.1.2) was disclosed in the letter of 23 December and was part of the MCA paper on SSRIs (pages 156 - 167) presented to the meeting of CSM on 26 March 1998.