EMA Improves Package Leaflets for Human Medicines

The EMA has introduced some changes on package to contribute towards the safe and effective use of medicines.

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 c