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Medicines Commission (Appeals)

Volume 130: debated on Monday 21 March 1988

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To ask the Secretary of State for Social Services how many appeals to the Medicines Commission against recommendations from the Committee on Safety of Medicines were heard in each of the years 1984, 1985, 1986 and 1987; in how many of these cases the Medicines Commission allowed the appeal; and in each of these cases where the advice from the Commission differed from that of the Commission on Safety of Medicines, what decision the licensing authority took and on what basis.

The information is as follows:

Year1234
19849541
19857541
1986322
19871222

Key:

Column 1: Hearings before the Medicines Commission and written representations considered by the Medicines Commission against advice by the Committee on Safety of Medicines (CSM).

Column 2: Advice by Medicines Commission to determine application other than as advised by CSM.

Column 3: Determined by the licensing authority in accordance with Medicines Commission advice.

Column 4: Determined otherwise.

Notes:

1. The case determined otherwise in 1984 would have required amendment of the Prescription Only Order to make a substance legally available without prescription.

2. In the 1985 case determined otherwise than on the Commission's advice, it was ascertained after the Medicines Commission proceedings that information relevant to the safety of the medicine had not been made available to them by the company concerned. Current Medicines Commission practice requires companies to make available all relevant information for these proceedings.

3. In other cases, the licensing authority's own judgment on the information available to it gave it no reason to differ from the advice of the Medicines Commission.

4. In most cases, new evidence unavailable to the CSM was submitted to the Medicines Commission; or the proposed licensing conditions were altered by the company; or both.