EU legislation requires that new Marketing Authorisations must include evidence that the PIL is clear and understandable to potential users of the medicine. Additionally, the leaflets of existing medicines must be tested to demonstrate readability starting 1st January 2009. For those who wish to reference the legislation, Articles 59(3) and 61(1) of Council Directive 2001/83/EC, as amended by Directive 2004/27/EC, require that the Patient Information Leaflet `shall reflect the results of consultations with target patient groups’ and that those results `shall also be provided to the Competent Authority.’ User testing of Patient Information Leaflets meets these obligations. RUAL FARM conducts user testing on subjects and produces a submission-ready report for clients. Our user testing is never sub-contracted to another organisation. As a result, our testing identifies obstacles to people’s ability to understand and use the information presented in leaflets. In addition, the primary objective of testing is not only to improve the quality of information, but to indicate any problem areas which need to be addressed or changes that could improve the PIL.

Why use RUAL Farm ?

We are an established regulatory consultancy company.

We are CERTIFIED by the National Agency for Medicines and Medical Devices. (view the document)

We have significant experience on preparing and updating PILs

We offer a fixed price user testing service. There are no additional, hidden costs.

We have a pre-recruited subject database so there is no delay in recruiting subjects.

We make customer satisfaction as an absolute priority.