European Guidance

MRFG/CMD(h) Concept Paper - Achieving
Harmonised Patient Information

Guidance Concerning “Consultations with
Target patient Groups” for the Package Leaflet (PDF 29k)

A Guideline on the Readability of the Label
and Package Leaflet of Medicinal products for
Human Use

Useful Information

Legislation and Guidance
MHRA Guidance

Guidance on the User Testing of Patient
Information Leaflets. (PDF 32K)

Questions and Answers to Support the MHRA
Guidance on User Testing (PDF 37K)

Best Practice Guidance on Labelling and
Packaging of Medicines”(PDF 222K)

MHRA Letter to MA Holders (PDF 330K)

Quality Criteria for PILs (PDF 18K)

Additional questions and answers on user
testing of patient information leafl ets
June 2006 (PDF 22K)

Further guidance on designing patient information leaflets and how to achieve success in user testing - March 2007 (PDF 38K)

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)