- It must be written and designed to be clear and understandable
- It shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.
- There should be more focus on improving the package leaflet rather than the SmPC. Language used is often too complex and the design and lay-out are not always user-friendly.
- Consider amendments of Guidelines and QRD templates to enhance readability of package leaflet
- Further improve the input from patients during the user testing process and the related methodology e.g. ensure that a sufficiently mature version of the package leaflet is user-tested.
- Best practice examples of aspects of the package leaflet design could be made available for companies.
- Explore the use of electronic media to provide the information included in the package leaflet (and SmPC) in the future (complementary to paper)
- Potential introduction of the “key information” section with the objective to allow rapid identification key safety messages.