Readability tests (testing the readability of package leaflets of medicinal products)
The aim of the survey is to make package leaflets of medicines as clear and simple to the patients as possible. During the survey, the following features are determined and improved:
- Finding necessary information about a drug;
- Understandability of information;
- Applicability of information.
When registering a drug, the manufacturer must prove that readability tests of package leaflet have been carried out. The manufacturer must present a package leaflet readability test report to authorities. EU Directive 2001/83/EC as amended by Directive 2004/27/EC provide that a package leaflet must be “legible, clear and easy to use”.