The draft of the revised "Guideline on the
Readability of the Label and Package Leaflet of Medicinal Products for
Human Use" was published in September 2006. The guideline defines the
basic requirements on the design of the outer packaging and the label of a
medicinal product including requirements regarding Braille. The guideline
is structured as follows:
Chapter 1 – "Readability of the Label and the Package Leaflet"
deals among others with the font size (12 point) and print type.
Chapter 2 – "Specific Recommendations for Blind and Partially Sighted
Patients" deals with the requirements on Braille.
Chapter 3 – "Guidance concerning Consultations with Target Patient
Groups for the Package Leaflet" requires that patients of the target
group give their feedback on the package leaflet so as to ensure that the user
information is readable, understandable and easy to use. Annex 1 contains
a suggestion on how such an assessment of the package leaflet's text by
the patients of the target group could be done.
The complete document can be found
here.
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