Readability Testing

Readability Test

Readability tests are conducted with due consideration of the following regulations and guidelines:

• Decree 30/2005 (VIII. 2.) EüM
• European Commission: Guideline on the readability of the labelling and package leaflet of medicinal products for human use. Revision 1, 12 January 2009.
• European Commission: Guidance concerning consultation with target groups for the package leaflet. May 2006
• CMDh: Consultation with target patient groups – meeting the requirements of article 59(3) without the need for a full test – recommendations for bridging. Revision 1, April 2009.

How Does the Test Work?

Interviews required for the evaluation of readability tests are conducted for registered products using the package leaflet corresponding to the current marketing authorization or final approved mock-up, involving the participation of at least 20 prospective patients, up to a maximum of 45 minutes per interview, with a minimum of 10–15 questions depending on the content and length of the package leaflet.

Based on the interviews, we compile an evaluation report and, where necessary, recommend amendments to the package leaflet to the MAH, as well as assisting with the related regulatory administration.

Regulatory Background

In accordance with the applicable regulations governing the registration of medicinal products and the requirements of OGYI, Decree 30/2005 (VIII. 2.) EüM on the labelling and package leaflet of medicinal products for human use requires that consultation be carried out with target patient groups corresponding to the product's indication in order to finalize the package leaflet.