Updated excipient labelling guideline out for comment
The European Commission is revising the guidelines for excipients in labelling and package leaflets of medicinal products for human use adopted in 2003, and has produced a new draft that is open for comments until 22 May.
Under EU regulations, all excipients must appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging if the medicinal product is an injectable or a topical or eye preparation. The package leaflet must also list the qualitative composition of active substances and excipients.
"An amended version of the guideline has been prepared in order to reflect the development since publication of the original version," says the Commission. It includes a list of excipients which should be stated on the label and outlines the information for those which 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," says the guideline. "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-, oro-, nasal-, rectal- or vaginal mucosae, i.e. where the delivery may be local or transdermal."
"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, then on the immediate package)."
IPEC Europe has circulated the draft document to the members with the intent of collating feedback for submission back to the EC. More updates will be provided in due course.