MHRA ‘PIL of the Month’ award for Pharmalink Consulting
To ensure that Patient Information Leaflets (PILs) of medicinal products are clear and easily understood by patients, current EU legislation demands that each PIL is subjected to ‘user testing’.
A questionnaire is designed to gauge how easily, or otherwise, the patient would be able to understand the PIL. The questions are then put to members of the public and results are fed back to the licence holder of the particular product.
The layout and content of the PIL may then be altered to ensure better understanding by the patient.
To promote this new initiative and share best practice, the MHRA are publishing a series of examples to illustrate improvements and to aid learning.
One such PIL which Pharmalink Consulting tested on behalf of a European Client was selected by the MHRA as ‘PIL of the Month’: http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON054687
The PIL user testing team at Pharmalink is delighted to have been able to help the Client with this project. The Client expressed their delight at receiving this accolade and also their appreciation of Pharmalink’s efforts.
