what are the european readability guidelines for package leaflets?
New European regulations have been introduced to improve the
readability of package leaflets (Guideline
2004/27/EC). In the case of new medicinal products, the package
leaflet has to be submitted to consumer panels. These panels could
consist of patient organisations or consumers who perform a package
leaflet test.
The readability test of a package leaflet has to
investigate:
- findability (can the subject find the right information)
- comprehensibility (can the subject the text in his or
her own words)
- applicability (can the subject do what the text says)
The MEB assesses the readability test and where appropriate
makes suggestions as to how the package leaflet text could be
improved.