The MHRA requirements for Patient Information Leaflets are below.
Patient Information Leaflets (PILs)
Unless all the information is on the pack, all medicines must include a PIL, regardless of how patients get them. PILs must:
- be easy to understand
- not contain personal information that can identify an individual, including names of staff members or digital signatures
Each product authorised under a marketing authorisation must have its own leaflet as explained in our best practice guidance on patient information leaflets. Also see MHRA guidance document always read the leaflet - getting the best information with every medicine
Our assessment of PILs includes a review of the font, colours, text size and layout of the information to assure the accessibility and readability of the statutory information.
Follow this link for the full MHRA notes:
https://www.gov.uk/guidance/medicines-packaging-labelling-and-patient-information-leaflets
This means that a pharmacy must supply the appropriate PIL with every medicine they dispense and every time they dispense it. They must not use a PIL from another product. They cannot refuse to supply a PIL.
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[i][b]MHRA - Patient Information Leaflet[/b]
The MHRA requirements regarding Patient Information Leaflets.
Last update 10/02/2025[/i]
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https://helvella.blogspot.com/p/mhra-patient-information-leaflet.html
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