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The price for one Readability User Testing (RUT) includes all activities needed to prove readability of PIL according to provision of Articles 98 and 99 of Low on Medicines and “Guideline on the readability of the labelling and package leaflet of medicinal products for human use” of EC Directive 2001/83/EC:
• Revision of PIL
• Corrections of PIL according to the guidelines, QRD9 implementation
• Mock-up design if necessary
• Questionnaire for respondents
• Testing of respondents in 3 rounds (total of 25 respondents)
• Statistical analysis of data
• Compilation and delivery of RUT report
• Possible corrections according requests from the Agency
Please note that we can deliver RUT both in English and Croatian. So, we can offer this service for other markets as well.
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