EMA published draft guideline on excipients in the labelling and package leaflets of medicinal products

A consultation document has now been released on the draft revision to the guideline, and the full consultation document can be found here.

The purpose of this revision document is to update the information regarding excipients that will be included in the package leaflet and SmPC. The revised Annex contains warning statements that must be included, to ensure the safe and effective use of the medicinal products that do contain any of the excipients listed; it contains some excipient statements that have been revised from previous the current guideline and some others that are new to this draft guideline.

The draft guideline outlines the timetable under which the new statements for the excipients listed in the Annex must be included into new and existing product information:

  • For new marketing authorisation applications, implementation as per the latest revision of the guideline should be followed.
  • For existing marketing authorisation holders, the first upcoming regulatory procedure that affects the Product Information should also include the implementation of these statements if applicable.
  • For products that do not have regulatory activities, a Type – IB variation of Article 61(3) notification should be submitted within 3 years of the publication of the revised guideline.

The European Commission for Public Health have launched the targeted stakeholder consultation, and the details of this can be found here.