European Medicines Agency improves package leaflets
The European Medicines Agency has updated the template for package leaflets for human medicines, to make the information easier for patients to understand and to include new sections on medicines' benefits and their uses in children.
The Agency introduced these changes to contribute towards the safe and effective use of medicines. They address the feedback from five years of user testing and from a range of stakeholders, including patient and consumer groups, national medicines regulatory agencies, the pharmaceutical industry and academics.
This feedback included concerns that the package leaflet needed to be more readable with fewer rigid standard statements, and that patients needed more information on the benefits that medicines can bring and on their uses in children.
The update also takes the Agency's report on the expectations of patients, consumers and healthcare professionals regarding benefit-risk information into account, as well as the requirements of the paediatric regulation.
The Agency's Working Group on Quality Review of Documents introduced these changes as part of the latest revision of the human product information templates.
In addition to the package leaflet, the revision included changes to the templates for the summary of product characteristics, labelling, and 'annex II', the section of the product information covering the conditions imposed on marketing authorisations.
The updated templates are available in all official European Union languages, as well as Icelandic and Norwegian, together with an implementation plan. Versions of the templates showing the latest updates as 'tracked changes' are also available.