The European Medicines Agency's (EMA) Working Group on Quality Review of Documents (QRD) develops, reviews and updates templates for product information for use by applicants and marketing authorisation holders for human medicines. This Group has published two public consultations detailed below.
EMA public consultation on a potential Key Information Section in the Package Leaflet of centrally authorised medicinal products - Deadline: 31 May 2025
The European Medicines Agency has published a public consultation on a potential Key Information Section in the Package Leaflet of centrally authorised medicinal product.
The European Medicines Agency and the Quality Review of Documents (QRD) Working Group are currently working on the revision of the QRD template for centrally authorised medicinal products for human use, with the aim of improving the content and structure of the package leaflet and making it more understandable and relevant to patients, while still complying with the current legislative framework.
Separate from the public consultation of the QRD template, EMA would like to gather the views of stakeholders on the potential usefulness and added value of a new “key information section” in the package leaflet. The addition of this new section addresses one of the recommendations in the Report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and it would allow patients, users and healthcare professionals to rapidly identify key safety messages, balanced with information on the benefit-risk profile of the medicine.
As concluded in the report, the evidence and views collected may help inform the decision on whether such a key information section in the package leaflet is needed and, if so, what type of information should be provided therein.
EMA would like to invite all interested stakeholders to respond to the following survey by 31 May 2025:
EU Survey: Potential inclusion of key information section in package leaflet of centrally authorised medicines - public consultation.
More information is available: Product-information (QRD) templates - Human.
EMA public consultation on version 11 of the Quality Review of Documents template
EMA is inviting all interested stakeholders to comment on a public consultation on version 11 of the quality review of documents (QRD) template.
Stakeholders include the pharmaceutical industry, national competent authorities, patients, healthcare professionals and academia.
EMA is revising the QRD template for centrally authorised medicines for human use mainly to improve the content and structure of their package leaflet.
This aims to make the package leaflet more understandable and relevant to patients, while complying with the current legislative framework, Directive 2001/83/EC.
Main proposed changes include:
• Deleting or making certain text optional to shorten the leaflet
• Creating standard statements to improve patient-friendliness and consistency across products
• Relocating important information at the beginning of the leaflet
• Clustering information by subject to make it easier to locate
• Reorganising warnings / precautions in a more logical order
You can submit your views by completing the form available on the consultation website and sending it to qrd@ema.europa.eu.
The deadline for comments is 31 August 2025.
The draft QRD template v11 can be found in both clean and track change versions.