DESIGN and LAYOUT
The design and layout of the information is crucial in helping patients to find
and understand the important messages within the PIL. Before submitting a
leaflet for user testing you should take time to review the way in which the
information is set out within in the document and take account of best practice
in this area in addition to re-ordering the information to comply with the new
article 59(1) of Council Directive 2001/83/EC.
Many test houses will offer to review and improve the design and layout of the
information in the PIL to ensure a high quality PIL is achieved and there is
more chance of a successful outcome in the user test. You are advised to
take advantage of these services.
Key points