Readability Test

PACKAGE LEAFLET READABILITY TEST

All medicinal products which are placed on the market are required by the law to be accompanied by labelling and package leaflet which provide a set of comprehensible information enabling the Patient to use the medicinal product safely and appropriately.
In accordance with Article 59(3) of Directive 2001/83/EC, the package leaflet shall reflect the results of consultations with target Patient groups to ensure that it is legible, clear and easy to use.

WHAT IS PACKAGE LEAFLET READABILITY TEST?

As mentioned above and in reference to the Article 63(2) of Directive 2001/83/C, the package leaflet must be written and designed in such a way as to be clear and understandable, enabling users to act appropriately (when necessary with the help of health professionals). Furthermore, the package leaflet must be clearly legible in an official language or official languages of the Member State where the medicinal product is placed on the market.
The Package Leaflet Readability Test is a flexible tool that allows to determine whether the way the information is presented in the leaflet allows for its correct reception and understanding by appropriately selected test participants.
The test should be carried out using the same leaflet which will be attached to the medicinal product and in accordance with the existing graphic design (mock-up) of the leaflet.