Better labelling planned in Europe of excipients for safe use of medicines

The European Medicines Agency and the European Commission have updated the annex to the EC guideline on excipients on the labelling and package leaflet of medicinal products for human use.

Excipients refer to everything in a medicine other than the active substance. While most excipients are considered inactive, some can have a known action or effect in certain circumstances. These must be declared in the labelling of the medicine for its safe use.

The updated annex contains all excipients that must be declared in a medicine’s labelling and package leaflet and their agreed safety warnings. The main aim of this update is to take into account safety concerns which are not currently addressed in the existing annex to the guideline. It also pays specific attention to, for example, the safety of these excipients when used in children or pregnant women.