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 a public consultation detailed below.
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.