§ Mr. FlynnTo ask the Secretary of State for Health on the basis of what prior trials and other research Lariam (Mefloquine) was granted marketing authorisation in the UK in 1989; and if he will make a statement. [48749]
§ Ms JowellThe decision to grant a marketing authorisation for lariam (mefloquine) was based on all the available evidence, published or unpublished and whether or not favourable to the application. The data submitted by the company were assessed by the Medicines Control Agency, who sought the advice of the Committee on Safety of Medicines (CSM), the Government's independent drug safety advisory body. The CSM was satisfied as to the safety, quality and efficacy of the product, the sole criteria under both European Community and national legislation.