§ Mr. CongdonTo ask the Secretary of State for Health what assessment his Department has made of ways of presenting the benefits of medicines to patients as well as their known side-effects in the proposed patient information leaflet. [38286]
§ Mr. MalonePatient information leaflets are drawn up in line with European directive92/27/EEC which prescribes the information which must be conveyed to the patient in such a leaflet. Guidance for the pharmaceutical industry on the preparation of leaflets was provided in 1993.
§ Mr. CongdonTo ask the Secretary of State for Health when he plans to proceed with the patient information leaflet initiative; and what have been the reasons for the delay. [38285]
§ Mr. MaloneEuropean directive92/27/EEC requires that a patient information leaflet be supplied with all medicines within five years of its implementation on 1 January 1994. Agreement was reached with the pharmaceutical industry to introduce the information 220W prescribed by the directive for the products in each therapeutic category of medicine simultaneously. A phased programme to do this began in December 1995 and will continue until the end of 1998.
§ Mr. CongdonTo ask the Secretary of State for Health who is responsible for deciding the suitability of the content of patient information leaflets. [38287]
§ Mr. MalonePatient information leaflets provided with medicinal products are drawn up by the marketing authorisation holder and are approved for use by the Medicines Control Agency.