According to Directive 2001/83/EC as amended by Directive 2004/27/EC, the readability of the labelling and package leaflet of medicinal products for human use became mandatory across the European Union, requiring that consultation with target patient groups (‘user consultation’) be carried out to demonstrate the readability and usefulness of the labelling and package leaflet to patients.
Pharmafile have established quality standards throughout the process, developing accepted standardised methods for generating, recording and reporting.
Pharmafile offer a service that meets your needs from:
Writing protocol and developing questionnaires
Assessing and reviewing existing leaflets
Writing and designing a leaflet or
Creating a leaflet template for product portfolios
Recruitment of test participants
Arranging and undertaking one to one interviews
Writing the final “submission ready” report for submission
Bridging reports – Abridged and full (focus testing)
Successful Readability User Testing reports have been generated for all product presentations in respect of National, CP, MRP and DCP submissions throughout the EU.
Initial application / Supplementary information
Periodic Safety Update Reports (PSURs)
For more information please contact us at: firstname.lastname@example.org