The Pharmaceutical Journal
Vol 269 No 7220 p560
19 October 2002

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News summary

Call for all new medicines to be tested for children

Members of the European Parliament are pushing for changes to proposed European Union legislation on the authorisation of medicines so that it requires all new medicines to be tested for their suitability for children.

Changes supported by the European Parliament’s environment committee say that a database on medicinal products should include information about which medicines are specifically authorised for administration to children.

Another amendment demands that patient information leaflets should include the words “newly authorised medicinal product: please notify any adverse reactions” for the first five years of sale.