According to the European drug legislation a testing is mandatory whether the texts of patient information leaflets are understood by the consumer, and whether the consumer is able to appropriately act upon the information. This testing is a precondition for marketing authorizations of medicinal products or their registration. Ultimately the test is a measure for the improvement of consumer safety: its intention is to make the application of a medicinal product as safe and efficacious as possible for the patient.
The readability user test is an essential part of the documentation of dossiers for marketing authorizations of medicinal products. The test must be performed with typical consumer groups.
GBA Pharma can offer you the performance of such tests for the compilation of dossiers for marketing authorizations or drug registrations.
Quick, safe and cost-effective. Contact us – we will be happy to advise you.