HC Deb 11 January 2000 vol 342 cc137-8W
Mr. Maclean

To ask the Secretary of State for Health if he will make a statement on the Government's assessment of the public response to the Medicines Control Agency's proposals for classifying borderline products, as published in its consultation letter MLX 249. [100254]

Yvette Cooper

As a result of the public response to the consultation proposals, we announced on 16 July that changes would be made. The three principal changes are as followsthe draft regulations will include an express requirement for full disclosures of the reasons for the Medicines Control Agency's provisional and final determinations; the review panel to look at the MCA's provisional determinations and advise the licensing authority—the licensing authority will be independent of the MCA; if a final determination is challenged, the MCA will have to prove in any criminal proceedings that the product is a medicinal product.

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