Luto can enhance the clarity and readability of your Package Leaflet using our unique ‘Audience Design Step’ and ensure it meets regulatory requirements.
A well written and carefully designed Package Leaflet can help patients find the information they need to use the medicine safely.
Using our years of experience and multidisciplinary team of experts, Luto have helped improve the readability of hundreds of Package Leaflets.
Our service includes a unique ‘Audience Design Step’ (ADS). This involves input from an experienced team of information design specialists, pharmacists, academics and expert patients to enhance readability of the Package Leaflet.
To assess how well a leaflet works in practice, Luto can conduct readability User Testing, a formative and iterative method used to ensure compliance with Council Directive 2001/83/EC (as amended by 2004/27/EC):
What we offer
Writing a Package Leaflet from SmPC
Readability enhancement of existing Package Leaflet, medicine labels and packaging
Compliance with EU QRD template
Readability User Testing of labelling materials
“The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.”