Requirements for a Package Leaflet
Council Directive 2001/83/EC as amended by the Council Directive 2004/27/EC includes the following requirements in terms of the legibility and understanding of the package leaflet;
“The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use” (article 59(3)).
In a previous article, we presented one option to meet this requirement which was the submission of a User Test Outcome Report. However, not every package leaflet needs to be subjected to a separate test and alternative evidence may take the format of a Bridging Report.
The term “bridging” is used to describe the situation where, because the leaflets are sufficiently
similar in both content and layout, a successful user consultation on one package leaflet can be used to demonstrate that another package leaflet meets the requirements of Article 59(3).
Bridging will normally be acceptable for package leaflets for medicines in the same therapeutic class where the key safety information is similar. As the design and layout of the information in the package leaflet are crucial to the way in which patients access the key messages for safe use, bridging will be easier to achieve where the package leaflets have a common design, layout, and style of writing.
