Calls for authorisation rule changes

Published: 1-Nov-2002


MEPs are pushing for changes to proposed European Union legislation on the authorisation of medicinal products so that all new medical products should be tested regarding 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 in the first five years of sale, a medicine package leaflet should state: 'newly authorised medicinal product. Please notify any adverse reactions.'

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