Public Consultation on Key Information in the Package Leaflet

The European Medicines Agency (EMA) has launched a public consultation on a possible Key Information Section (KIS) in the Package Leaflet (PL) of centrally authorized medicinal products. The EMA invites all interested stakeholders to respond by 31 May 2025.

Background

The EMA and the Quality Review of Documents (QRD) Working Group are currently working on the revision of the QRD template for centrally authorized medicinal products for human use. The aim is to improve the content and structure of the PL, making it more understandable and relevant to patients, while still complying with the current regulatory framework. Separate from the public consultation on the QRD template, the EMA would like to gather stakeholders' views on the potential usefulness and added value of a new "key information section" in the PL. The addition of this new section would allow patients, users and healthcare professionals to quickly identify key safety messages, balanced with information on the benefit-risk profile of a medicine. The evidence and views collected may help to decide whether such a key information section in the PL is needed and, if so, what type of information it should contain.

For more information, see the EU survey: Potential inclusion of a key information section in the package leaflet of centrally authorised medicines - public consultation and the EMA website Product-information (QRD) templates - Human.