Launch of Public Consultation on Key Information in the Package Leaflet

The European Medicines Agency (EMA) has launched a public consultation on the potential inclusion of a Key Information Section (KIS) in the Package Leaflet (PL) of centrally authorized medicinal products. Stakeholders are invited to provide feedback by 31 May 2025.

This initiative is part of a broader effort by the EMA and the Quality Review of Documents (QRD) Working Group to revise the QRD template for medicinal products. The aim is to improve the clarity and relevance of the PL for patients, while ensuring regulatory compliance.

The proposed KIS would highlight key safety information and provide a balanced overview of the benefit-risk profile of the medicine, helping patients and healthcare professionals quickly identify essential information. Feedback from the consultation will help decide whether the KIS should be included and what content it should feature.

For more information, visit the EMA website or the EU survey on the proposal.

05-05-2025