Excipients labelling – EMA information
The European Medicines Agency (EMA) publishes information on excipients for inclusion in the labelling and package leaflet of human medicines.
EMA excipient definition:
“An excipient is a constituent of a medicine other than the active substance, added in the formulation for a specific purpose.”
(Quality of Excipients by EMA)
Marketing authorisation holders and applicants are required to list excipients on the medicine’s labelling according to the 2003 European Commission guideline pursuant to Article 65 of Directive 2001/83/EC:
European Commission guideline on ‘Excipients in the label and package leaflet of medicinal products for human use
The main body of the European Commission guideline is currently under revision based on comments received during a targeted stakeholder consultation.
According to Directive 2001/83/EC, all excipients in parenteral, ocular and topical medicines, as well as the excipients listed in the annex to the guideline maintained by EMA, must appear on the labelling.
In addition, all excipients listed in the annex must be included in the package leaflet together with the relevant information set out in the annex.
Annex to the European Commission guideline
The annex contains a list of all excipients known to have a recognised action or effect that need to be displayed on the label of any medicine authorised in the European Union (EU):
Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’
EMA’s Excipients Drafting Group (ExcpDG) reviews the annex regularly to update the information on excipients or include new excipients.
EMA published the updated annex in October 2017, after a public consultation for each excipient, adoption by EMA’s Committee for Medicinal Products for Human Use (CHMP) and endorsement by the European Commission’s Notice to Applicants Group.
The annex is effective from its date of publication.
For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the revised annex.
For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a type IB variation within 3 years after the publication of the revised annex.
List of updated excipients and background reviews
The ExcpDG prepares a report on each excipient under review, containing a scientific background review and the updated information for the package leaflet.
Aspartame and phenylalanine
Benzalkonium chloride
Benzoic acid and benzoates
Benzyl alcohol
Boric acid and borates
Cyclodextrins
Ethanol
Fragrance allergens
Fructose and sorbitol
Phosphates
Propylene glycol and esters
Sodium
Sodium laurilsulfate
Wheat starch (containing gluten)