Guidance on writing patient information leaflets

Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

Extensive advice and guidance on writing patient information leaflets (PILs) is available in Always read the leafletPDF file (opens in new window) (602Kb).

Specific guidance has been developed for writing PILs as follows:

› Can you read the leaflet? A guideline on the usability of the patient information leaflet for medicinal products for human usePDF file (opens in new window) (154Kb)

› Guidance on communication of risk in patient information leafletsPDF file (opens in new window) (121Kb)

› Glossary of medical terms in lay languagePDF file (opens in new window) (69Kb)

› Signposting from the Patient Information Leaflet to additional sources of information and other servicesPDF file (opens in new window) (69Kb)

› Guidance on information in the PIL to address areas of potential misuse or abuse of over-the-counter (OTC) antihistamine sleep aid and laxative medicinesPDF file (opens in new window) (35Kb)

For comprehensive guidance on user testing, please see the User testing of patient information leaflets page. Additional guidance is available on our Frequently asked questions page.

Page last modified: 26 June 2009