To meet the latest requests issued by the AIFA with the Communiqué of the 07/23/2013 (updated with the Communiqué of the 25.09.2013), Di Renzo Regulatory Affairs has set up a unit for the preparation of readability tests of patient information leaflets for medicinal products for human use.
Based on these Communiqués as of the 1 July 2015 all marketing authorization holders of medicinal products for human use authorized nationally must submit a type IB variation to update module 1.3.4 for the adaptation of the patient leaflet carried out by means of a readability tests, along with the report containing the results of the test.
This deadline also applies to requests for new marketing authorizations and line extensions using the national procedure still being assessed at the date of the Communiqué of 07/23/2013. The obligation also extends to requests for new marketing authorizations and line extensions that will be presented with a national procedure with effect from 1 January 2014.
Below are some of the services that Di Renzo Regulatory Affairs is able to offer companies:
- Identification of products on which to carry out the readability test and bridging report
- Preliminary examination of the SPC and PIL
- Adaptation of PIL into QRD format
- Running the readability tests in all envisaged phases including the recruitment of personnel to be interviewed
- Preparation of all documentation required, including planned cycles of interviews
- and the final layout of PIL
- Delivery of the final report in Italian or English
- We are at your disposal for further information and clarifications.