New rules will allow EU patients to report drug concerns directly

BMJ 2010; 341 doi: (Published 28 September 2010) Cite this as: BMJ 2010;341:c5344
  1. Rory Watson
  1. 1Brussels

    Patients will be better informed about drugs and be able to report any adverse effects directly to national authorities, after the European parliament overwhelmingly agreed new legislation on 22 September.

    Under the new pharmacovigilance requirements, which will apply across the European Union, national web portals will have to be established to provide the public with information on medicinal products and any known side effects. The portals will contain assessment reports, summaries of product characteristics, information leaflets, and advice for patients on how to report any concerns they might have.

    The national portals will be linked …

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