Updated annex to excipient guidelines has new safety advice for 15 excipients
The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients in 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.
The updated annex includes five new excipients and new safety warnings for ten existing excipients. The new safety information will help patients and healthcare professionals make more conscious decisions about the medicines they take and prescribe.
The updated annex takes account of the comments received for each excipient during public consultations and is published, in all European Union languages, along with scientific reports.
The revised annex applies to both centrally and nationally authorised products. For new marketing authorisation applications the revised annex will be effective from its day of publication and applicants must implement the information in the labelling. For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the revised annex. For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a type IB variation within three years after the publication of the revised annex.