Ahead of the next Pharmapack Conference, the European Commission has revised its guidance on the readability of consumer pharmaceutical labeling. This includes primary and outer packaging labels as well as leaflets / inserts.
The main purpose of this document is to provide guidance on how to ensure that the information on the package label and package leaflet / insert is accessible to and can be understood by those who receive it.
It includes information on how the requirements for Braille must be met with a suitable package leaflet format for the blind and partially-sighted consumer.
Interestingly, one of the conference topics on day 2 will address how Braille can be applied, verified and measured.
The guidance indicates that as a minimum the (invented) name of the drug followed by its strength should be available in Braille on the packaging of the product. Space being an issue for small volume products, recommendations such as contracted Braille or certain defined abbreviations are given.
The guideline also includes an example of methodology of validating the acceptability of the package insert.
This guidance has a fast approaching deadline – next June.
The EU document (PDF file) is available from the European Commission Website.
