EC Unveils Revised Guideline on Pharmaceutical Excipients

Regulatory NewsRegulatory News | 28 February 2017 |  By 

The European Commission on Tuesday opened for public comment a revised guideline concerning the list of excipients, defined as any constituents of a medicinal product other than the active substance and the packaging material, which must be included on the labeling of medicines, as well as the way in which these excipients must be indicated. 

The guideline’s revision, which the EC says reflects developments since 2003, 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.  

"All excipients in parenteral, ocular and topical medicinal products must appear on the labelling," the guideline says. "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)."

Excipients may include:

  • coloring matter, preservatives, adjuvants, stabilizers, thickeners, emulsifiers, flavoring and aromatic substances
  • constituents intended to be ingested or otherwise administered to the patient, of the outer covering of the medicinal products (hard capsules, soft capsules, rectal capsules, coated tablets, film-coated tablets, etc.)
  • transdermal patch constituents
  • excipient mixtures, “e.g. those used for example in direct compression or in a film coat or polish for an ingested dose form,”
  • pH adjusters
  • the constituents of printing inks used to mark the ingested dose form
  • diluents present, for example in herbal extracts or vitamin concentrates
  • the constituents present in a mixture of chemically related components (e.g. preservatives).

Stakeholders have until 22 May 2017 to comment on the revised guideline.

Guideline: Excipients in the labelling and package leaflet of medicinal products for human use



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