§ Mr. Atkinson
To ask the Secretary of State for Health what requirements exist for imports of generic medications to include an instruction leaflet in the English language.
§ Mrs. Virginia Bottomley
The Medicines (Leaflets) Regulations require that if a leaflet is supplied with any medicine it is to be in English. It is not mandatory under United Kingdom law to supply a leaflet, but European Community (EC) directive 89/341 introduces such a requirement effective in 1992, unless the necessary information is on the label. The content of leaflets to be supplied under directive 89/341 is to be laid down by a further directive which is expected to be discussed this year.