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”).