§ Mr. BlunkettTo ask the Secretary of State for Health whether she expects to produce a patient information leaflet for the drug Depo medrone.
§ Mr. SackvillePatient information leaflets are produced by pharmaceutical companies which market medicinal products and are authorised by the licensing authority. Under a European Community directive on the labelling of human medicines and leaflets—EC 92/27—copies of which are available in the Library, a package leaflet containing specified information for the patient has to be provided unless that information is on the product label. United Kingdom regulations implementing these provisions have been made and the new requirement came into force from 1 January 1994. Products already on the market, such as Depo medrone, have to meet the new requirements at the time of the five-yearly renewal of their licence.