European Commission releases new excipients guideline in the labelling and package leaflet of medicinal products in the EU

The European Commission has released a new guideline which provides marketing authorisation holders (MAHs) with a list of excipients that should be included on a medicine’s label and the information for those excipients that must appear on the package leaflet.

According to Directive 2001/83/EC, all excipients in parenteral, ocular and topical medicinal products must appear on the labelling; either the outer package or on the immediate packaging if there is no outer package. Topical medicinal products include medicinal products applied externally to the skin, respiratory products delivered to the lungs by inhalation and any medicinal product that is delivered to the ear, oral, nasal, rectal or vaginal mucosae where delivery is local or transdermal. For all other medicinal products, only excipients that are known to have a recognised action or effect included in this guideline, should be stated on the labelling.

The new guideline also explains that all excipients must be stated on the package leaflet by name, therefore all excipients, as indicated in the section on ‘Definitions and Examples’ should be declared according to the nomenclature in this guidance.

According to the Annex, when a warning or information statement is required “it should be clear in the package leaflet and summary of product characteristics (SmPC) that the statement is linked to the presence of a particular excipient.” It is important that the patient should not be left in any doubt as to whether the warning relates to the excipient or the active substance.

For some excipients, information such as “effects on ability to drive and operate machinery, pregnancy and lactation, undesirable effects, contra-indications, warnings and precautions”  included in the package leaflet may relate to more than one section of the leaflet. However to simplify the presentation of the package leaflet, “this information should appear only once”.

To ensure that the patient does not miss important and relevant information, it may be necessary to refer back to the excipient warnings section from other sections in the package leaflet. For example, with ethanol, it will be necessary to refer back to the excipient warnings section from those sections relating to effects on ability to drive, pregnancy and lactation, and information for children.

To view the new guideline on excipients in the labelling and package leaflet of medicinal products for human use, please click here.