Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'

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.

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 IB variation 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.

For more information, see Excipients labelling.

Keywords: Excipients, package leaflet, labelling

Current version

All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 4

Adopted

Appendix - European Union list of fragrance allergens requiring labelling on cosmetic and detergent products

Document history - Revision 3

All languages - Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 3

Adopted

Document history - Revision 2

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 2

AdoptedReference Number: EMA/CHMP/302620/2017 Rev. 2

Document history - Revision 1

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 1

AdoptedLegal effective date: 22/11/2019Reference Number: EMA/CHMP/302620/2017 Rev. 1

Document history - First version

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Superseded

AdoptedLegal effective date: 09/10/2017Reference Number: EMA/CHMP/302620/2017 Corr.1

Concept paper on the need for revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00) - First version

Consultation dates: 07/03/2012 to 31/05/2012Draft: consultation closedReference Number: EMA/CHMP/SWP/888239/2011Summary:

The current guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00) contains warning statements relating to the presence of certain excipients in medicinal products. This is a Commission guideline pursuant to Article 65 of Directive 2001/83/EC. Article 54(d) of the above Directive requires that all excipients need to be declared on the labelling if the medicinal product is an injectable, or a topical or an eye preparation.

Volume 3b guidelines: Medicinal products for human use: Safety, environment and information: Excipients in the label and package leaflet of medicinal products for human use

AdoptedReference Number: 3bc7a