There are precise guidelines given by the legislator regarding which information a package leaflet must contain. Amongst others, it has to contain the name of the medication, the therapeutic principle, contraindications, interactions and side effects. But the patient will only be able to take the medication correctly if he actually understands the patient information leaflet.
According to German Medicines Act (AMG) you have to submit evaluations of the patient information leaflet which are done in cooperation with the patient target group. With the help of these tests readability and comprehensibility are checked and patient friendly leaflets are developed. gottschalk research has created a test consisting of the following components: review of the leaflet, pretest and, if necessary, modification of the leaflet, evaluation by test person, measurement of comprehensibility of information and a concluding evaluation of the interviewer. As a result we will provide a final report to be presented to the appropriate authorities.
Please contact us for detailed information