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Test Leggibilità

Advice on product information and readability testing of human medicines

Regulation (EC) 726/2004 and Directive 2001/83/EC, as amended, provide for that the product information of a medicinal product is appropriately reported in the Summary of Product Characteristics (SmPC), Package Information Leaflet (PIL) and labelling. In addition, the package information leaflet should be easy to read and understand by its users.

For all these reasons, it is necessary to take great care of these documents that are integral part of an authorisation dossier, and to comply with all their requirements.

The main services offered by Di Renzo Regulatory Affairs in this field are:

  • Preparation, control and translation of the SmPCs, labelling and information leaflets
  • Performance of readability testing, Focus Test and preparation of Bridging Reports for the package leaflet
  • German translation of the package leaflet and labelling (bilingualism) and update in the Unifarm database
  • Preparation and control of artworks for the immediate and secondary packaging and for the package leaflet
  • Assistance with Farmastampati service and stock disposal
  • Pharmaceutical packaging graphic design