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Generic Medicines

Volume 165: debated on Wednesday 17 January 1990

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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.

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.