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Excipients in the Labelling and Package Leaflet | EMA Guidance

This document is an annex to the European Commission guideline on Excipients in the labelling and package leaflet of medicinal products for human use.

It contains a list of excipients with a known action or effect, which must appear on the labelling of medicines in the European Union (EU), and the information which should appear in the package leaflet.

Below information is available in the annex:

  • Name 
  • Updated on 
  • Route of Administration
  • Threshold 
  • Information for the Package Leaflet
  • Comments

Each revision of this annex is effective from its date of publication. 

For authorised medicines, marketing authorisation holders should use the first opportunity to implement any revised wording in the package leaflet.

For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a type-.I Bvariation within 3 years of the revision date of the relevant excipient.

Marketing authorisation holders can find the revision date for a particular excipient in the column ‘updated on’, next to the excipient's name in the annex.

Source: EMA

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