Module 6

04/10/2024

Patient Leaflet Guidance

⚫ Guideline On The Readability Of The Labelling And Package Leaflet Of Medicinal Products For Human Use, Rev 1 2009

● Chapter 1 - Principles for font, type size, layout, design, paper weight

● Chapter 2 - Specific recommendations for blind and partially-sighted patients – Package Leaflet to be provided by the MAH upon request from patient organisations – For the partially-sighted: Large font size – For the blind: Format perceptible by hearing or Braille ● Chapter 3 - Guidance on the consultations with target patient groups

⚫ MHRA guidance – Best practice guidance on patient information leaflets

● Guidance on how to write good quality information for patients about medicines

● Recommended reading - Always read the leaflet: getting the best information with every medicine by Committee on Safety of Medicines: Working Group on Patient Information, Medicines and Healthcare products Regulatory Agency, et al. 19 Jul 2005

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User Testing of Package Leaflet

Introduced in Directive 2001/83/EC as amended by Directive 2004/27/EC

Guidance concerning consultations with target patient groups for the package leaflet, 2006 “The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use”

● Diagnostic user testing of patient information leaflets was pioneered in Australia in the early 1990s, and was recommended in guidelines on Readability in Europe by the European Commission in 1999

● User testing ensures that patients’ views on the content and design and layout are taken into account so that the final leaflet which is submitted as part of the MA enables most medicine users to take safe and accurate decisions about their medicines

● Guidance does not mandate one specific type of testing, however “user testing” (developed in Australia by Prof David Sless) has been adopted by most of industry and specific providers offer this service

● Can take 2-3 months to complete

● Possible to request a deferral to provide this during MAA assessment e.g. at time of response to questions

● Possibility for ”Bridging studies” applies to leaflets which are sufficiently similar in both content and layout.

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