Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Is ‘Readability Testing’ an adequate procedure to improve the legibility of package leaflets? A European comparison including German and British liability aspects

Dr. Astrid Kaufmann (Abschlußjahr: 2008)

Language: Englisch

Patients complain very often about package leaflets. Mostly they are not able to locate a certain information, or the package leaflet is written unclear and comprehensibility problems occur.

The ‚review 2004 implemented via 2004/27/EC ‚Readability Testing for more comprehensible package leaflets in Europe. The new requirements force pharmaceutical companies to test the legibility and comprehensibility of package leaflets for the medicinal products they market. But will ‚Readability Testing really improve a process which needs an immediate change? Might the comprehensibility and legibility problems not be caused by the length of the package leaflet?

Package leaflets in Great Britain and Germany differ greatly concerning the length and quantity of information. Possible reasons for this difference including German and British liability aspects concerning medicinal products will be discussed.

The liability discussion includes the product liability directive 85/374/EEC, the national implementation of this directive and the different path followed by Germany with the medicinal product liability via § 84 AMG. Furthermore a closer look how the doctors duty of ‚disclosure influences the length of a package leaflet is dared.

Pages: 51,
4 Annexes: 37 pages