Marketing authorisation holders and applicants need to identify the excipients included in any human medicine authorised in the European Union (EU) in its product information. Guidance is available from the European Commission and European Medicines Agency (EMA) on what needs including in the labelling and package leaflet.
An excipient is a constituent of a medicine other than the active substance, added in the formulation for a specific purpose. While most excipients are considered inactive, some can have a known action or effect in certain circumstances. These must be declared in the labelling and package leaflet of the medicine for its safe use.
|Type of excipient||Type of medicine||Type of information||Display location|
|All excipients||All medicines||List of excipients||Package leaflet|
|Parenteral, ocular and topical medicines||List of excipients||Labelling|
|Excipients with a known action or effect||All medicines||List of excipients||Labelling|
|Agreed safety information||Package leaflet|
These requirements apply to all medicines in the EU, irrespective of whether they are centrally or nationally authorised.
Background information supporting the EU requirements for individual excipients can be found on the relevant webpages, which are listed below.
- Aspartame and phenylalanine
- Benzalkonium chloride
- Benzoic acid and benzoates
- Benzyl alcohol
- Boric acid and borates
- Fragrances containing allergens
- Fructose and sorbitol
- Propylene glycol and esters
- Sodium used as an excipient in medicinal products for human use
- Sodium laurilsulfate
- Wheat starch containing gluten