Public Consultation regarding Key Information in the Package Leaflet

The European Medicines Agency (EMA) has opened a public consultation on introducing a Key Information Section (KIS) in the Package Leaflet (PL) of centrally authorized medicines. Stakeholders are invited to submit feedback by 31 May 2025.

This initiative, led by the EMA and the Quality Review of Documents (QRD) Working Group, aims to revise the QRD template to make PLs clearer and more patient-friendly while complying with regulations. The proposed KIS would help patients, healthcare professionals, and users quickly access key safety messages and balanced benefit-risk information about medicines.

The consultation will gather opinions on the need for such a section and the type of content it should include. More details and the survey are available on the EMA website under Product-information (QRD) templates – Human.

19-05-2025