All medicines placed on the market must have a label and an information leaflet. Thus, and in accordance with Article 59 (3) of Directive 2001/83/EC, during the process of submitting a Marketing Authorisation (MA) dossier, the holder must ensure that the information in the package leaflet is legible, perceptible, easy to use and clear to the user/patient to enable the correct use of the medicine.

One way to ensure that the information presented in the leaflet allows users/patients to understand it correctly is through readability tests. These are carried out with the target audience of patients and identify which areas of the package leaflet need to be rectified.

The results of the readability test must follow the structure: description of the product/medicine; details of the readability test (such as the method used, explanation of the choice of population consulted or language used); questionnaire (including instructions and observations); original and revised information leaflet; discussion of the results obtained (responses, problems identified, and revisions made to parts of the package leaflet); conclusion.

The final report should be provided to competent authorities so that the package is correctly used by all people likely to use the medicinal product in question.

In certain situations, demonstrating the legibility of the package leaflet can be done through bridging studies, if the package leaflet shows to be similar to another package leaflet that has already proven to be legible. In this case, there is no need for a new readability test since the confirmation of successful readability on the “parent” leaflet provides evidence to justify the readability of the “daughter” leaflet and the absence of a new test.

These studies make a detailed comparison between the two leaflets based on the similarity of the content and layout. They must also ensure that the key messages are similar, both have the same design, and writing style, and allow the correct use of the medicine by the user/patient. Some of the factors that should be compared are font type and size, headings and subheadings, size of the package leaflet, the color used, critical security sections, and use of pictograms or paperweight.

From these data, the bridging report must be prepared, in which the main messages in the package leaflet for the safe use of the medicine must be discussed and must be justified how these issues were evaluated in the readability test carried out for the original package leaflet.

It is possible to use bridging reports, among other situations, in the submission of a MA for medicines of the same therapeutic class, with more than one dosage or pharmaceutical form or intended for the same target population.

 

References:

- Guideline on the readability of the labelling and package leaflet of medicinal products for human use Revision 1, 12 January 2009

- Consultation with Target Patient Groups – meeting the requirements for article 59(3) without the need for a full test – Recommendations for bridging