Toolkit for an understandable package leaflet
The package leaflet has to be easy to read and understand for users. This page contains tips and resources for anyone who wants to work on creating an understandable Dutch language package leaflet. Is the Dutch package leaflet text a translation of an English text that has been approved in Europe? Even then the tips and resources can still be used.
The toolkit can therefore be used:
- for products with a marketing authorisation obtained via the national, MRP/DCP or centralised procedure.
- to make - parts of - an existing package leaflet more understandable, or when drawing up a new package leaflet text.
However, you should check whether the product is a generic product. Where possible you should then keep to the Dutch package leaflet of the reference product. If the package leaflet text of the reference product is not easy to understand, you should inform the marketing authorisation holder of the reference product in question.
If you have any questions or comments, please contact the Better Use Programme.