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Useful links
Legislation and Guidance
MHRA Guidance
"Guidance
on the User Testing of Patient Information Leaflets"
"Questions
and Answers to Support the MHRA Guidance on User
Testing"
"Best
Practice Guidance on Labelling and Packaging of
Medicines"
"MHRA
Letter to MA Holders"
"Quality
Criteria for PILs"
"Additional
questions and answers on user testing of patient
information leaflets - June 2006"
"Further
guidance on designing patient information leaflets
and how to achieve success in user testing - March
2007"
"Guidance
for the Pharmaceutical Industry on the use of
bridging studies to demonstrate compliance with
article 59(3) of Council Directive 2001/83/EC
[Consultation with Target Patient Groups]"
European Guidance
"MRFG/CMD(h)
Concept Paper - Achieving Harmonised Patient Information"
"Guidance
Concerning "Consultations with Target patient
Groups" for the Package Leaflet"
"A
Guideline on the Readability of the Label and
Package Leaflet of Medicinal products for Human
Use"
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