§ Mr. Ashleyasked the Secretary of State for Social Services (1) if a new product licence was necessary before the Department of Health and Social Security gave permission for the reformulated drug Debendox to be made available;
(2) on what date Merrell Pharmaceuticals Ltd. informed the Department of Health and Social Security that it intended to reformulate Debendox by omitting the dicyclomine hydrochloride component; when his Department's approval was asked for and given; and whether sales of the previous three-part drug have now been suspended or if they will continue until stocks are exhausted.
§ Mr. Geoffrey FinsbergMatters relating to the licensing of individual drugs are confidential for commercial reasons. A change in formulation of a medicinal product can be achieved by either an application for variation of the current licence, or an application for a new licence. I understand that Merrell Pharmaceuticals Ltd. is now supplying only the reformulated product.