Better Information for Consumer Medicines Project

MHRA user testing guidance and Q&A document
The Medicines and Healthcare products Regulatory Agency (MHRA) have published guidance on the user testing of Patient Information leaflets. This provides guidance on:

• Deciding how and when to apply a user test to PILs that accompany medicines for which you are responsible
• Information about one way of undertaking a user test
• Advice on who should be involved in the test process

You can download the guidance and Q&A documents here:

• Guidance on the user testing of Patient Information Leaflets
• Questions and answers to support the MHRA guidance on user testing

'Always read the leaflet' report
'Always read the leaflet' is a report conducted by the Committee on Safety of Medicines Working Group on Patient Information. It looks at getting the best information with every medicine.
Download Always read the leaflet here.

EU Guidance on user testing
The European Commission has published guidance on the readibility of PILs.
Download Guidance concerning "consultations with target patient groups" for the package leaflet here.

QRD templates
You can download the QRD templates from the EMEA website