In accordance with Article 65(e) of Directive 2001/83/EC1 the Commission shall draw up detailed guidance with the list of excipients which must feature on the labelling of medicinal products and the way in which these excipients must be indicated. Therefore this guidance contains the warning statements relating to the presence of certain excipients in medicinal products above a threshold defined in the Annex. Homeopathic medicinal products authorised through a special simplified registration procedure require a specific labelling according to Article 69 of Directive 2001/83/EC.
Although not addressed in this guideline, some of the information in the Annex may be used if relevant for these simplified procedures.