Readability of Label and Package Leaflet - Revised Draft of the European Commission

GMP News No. 837

GMP News
16 November 2006
 

Readability of Label and Package Leaflet –
Revised Draft of the European Commission

 
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.

 
   
To learn more about GMP requirements on packaging materials, the sampling of packaging materials and the control of incoming packaging materials, visit the ECA course
    
Quality Control of Pharmaceutical Packaging Materials
from 8-9 May 2007 in Vienna, Austria.

 
Author:
Dr Günter Brendelberger
On behalf of ECA
  

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK