3. Package Leaflet (PL)
1. Package Leaflet (PL)
1.1. PL process
The PLs are drafted by the pharmaceutical companies based on their data and a draft PL must be included in the application dossier in Module 1 (CTD). After submission of the dossier, a number of rounds of review starts involving different actors:
- Assessors from Member states
- EMA
- Patients
User Testing:
Additionally, user testing is performed during the procedure (a legal requirement
since 2005), not only looking at the content but also at the design and layout
of the leaflet. Article
59(3) of Directive 2001/83/EC states
that the PL shall reflect the results of consultations with target patient
groups to ensure that it is legible, clear and easy to use (e.g., format,
layout, contrast, spacing etc.). This needs to be documented in the applications
for marketing authorisations, significant variations to MAs, renewal
applications and applications where harmonisation of the PL is undertaken and
which must demonstrate compliance with article 59(3). Therefore, the company
must consult with target patient groups, and one way to do this is for the
company to perform a ‘user test’.
This often follows the recommendations of the ‘readability guideline’: a group of relevant patients is identified (appropriate number, gender, age, treatment naïve/patients?), The group will look at a test package (usually labelling and PL) and answer questions covering key messages (relevant, open questions, expected answers?) discuss the layout and make proposals for amendments where appropriate.
Not all language versions of the PL will undergo user testing. The company chooses the language in which the readability test is carried out. One of the limitations of this method is that the evidence for the positive result in other languages depends on the quality of the translation process. The PL text proposed by the company will be evaluated by the EMA Quality Review of the Documents (QRD) group.
Review of the PL can also occur for medicines already
on the market. This can happen due to major changes in the content but also on
a regular basis in terms of usability. One example of this would be adapting to
new techniques, e.g. the electronic leaflet (for instance in Germany package
leaflet (“Gebrauchsinformation 4.0”).