Patient Information Leaflet (PIL) User Testing (Readability Testing Service) - Europe

EU Law: "All medicines are required by European and UK law (Council Directive 92/27/EEC) to be accompanied by a Patient Information Leaflet (PIL) setting out comprehensive information which is accessible to and understandable by those who receive it, so that they can use their medicine safely and appropriately. The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible clear and easy to use. The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority."

It is a legal requirement that all products which are classed as medicines must be accompanied by comprehensive information i.e. a PIL. A medicine's Patient Information Leaflet (PIL) is intended to supplement the information provided by a healthcare professional and so it must be readily understood by the patient and/or carer. The User Testing of PILs is key to ensuring that their content is clear and understandable. Since 2005, the User Testing of PILs became mandatory for all new medicines across Europe. For existing medicines there was a transitional period but this ended on 30 June 2008.

As of April 2008, the UK Health Authority (MHRA) had noted that a "significant minority" of companies still hadn't complied with the legislation. As a result, the Patient Information Quality Unit (which assesses the User Testing reports) made some changes to the assessment process in an attempt to make compliance easier.

Many companies do not have the time or the in-house expertise to undertake the user testing of their PILs. With well over 200 full User Tests completed and approved, Global Regulatory Services can help you comply with the law.

Please contact us with your specific regulatory compliance requirements.