The European Commission this week issued a new guideline to provide marketing authorization 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 labeling (outer package, or if no outer package on the immediate packaging).
“Topical medicinal products can be taken to include those medicinal products applied externally to the skin (including transdermal patches), respiratory products delivered to the lung by inhalation and any medicinal product delivered to the ear, oral, nasal, rectal or vaginal mucosae, i.e. where the delivery may be local or transdermal,” the guideline says. “For all other medicinal products, only those excipients known to have a recognised action or effect, included in this guideline, should be declared on the labelling (outer package, or, if no outer package, on the immediate package).”
And according to an article of the same directive, all excipients must be stated on the package leaflet by name.
“When a warning or information statement is required according to the Annex, it should be clear in the package leaflet and SmPC [summary of product characteristics] that the statement is linked to the presence of a particular excipient. The patient should not be left in any doubt as to whether the warning relates to the excipient or the active substance,” the guideline says.
The guideline also notes that for some excipients, the information to be included in the package leaflet may relate to more than one section of the leaflet, “E.g. effects on ability to drive and operate machinery, pregnancy and lactation, undesirable effects, contra-indications, warnings and precautions.”
But to simplify the presentation of the package leaflet, “this information should appear only once,” the guideline says.
“However, in order 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 in the case of 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, information for children, etc.”
Guidelines: Medicinal products for human use Safety, environment and information: Excipients in the labelling and package leaflet of medicinal products for human use
Annex to the Guideline