Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
HumanRegulatory and procedural guidanceProduct informationScientific guidelines
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
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Appendix - European Union list of fragrance allergens requiring labelling on cosmetic and detergent products
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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
English (EN) (670.32 KB - XLSX)
First published:
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
English (EN) (319.8 KB - PDF)
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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: Reference Number: EMA/CHMP/302620/2017 Rev. 1
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български (BG) (199.42 KB - PDF)
First published: 22/11/2019
español (ES) (168.06 KB - PDF)
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čeština (CS) (238.76 KB - PDF)
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dansk (DA) (166.39 KB - PDF)
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Deutsch (DE) (175.39 KB - PDF)
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eesti keel (ET) (158.59 KB - PDF)
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ελληνικά (EL) (231.11 KB - PDF)
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français (FR) (175.6 KB - PDF)
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hrvatski (HR) (139.53 KB - PDF)
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íslenska (IS) (182.59 KB - PDF)
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italiano (IT) (165.88 KB - PDF)
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latviešu valoda (LV) (302.94 KB - PDF)
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lietuvių kalba (LT) (191.19 KB - PDF)
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magyar (HU) (182.16 KB - PDF)
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Malti (MT) (190.81 KB - PDF)
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Nederlands (NL) (177.2 KB - PDF)
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norsk (NO) (166.2 KB - PDF)
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polski (PL) (195.19 KB - PDF)
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português (PT) (169.75 KB - PDF)
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română (RO) (173.86 KB - PDF)
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slovenčina (SK) (182.42 KB - PDF)
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slovenščina (SL) (170.48 KB - PDF)
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Suomi (FI) (165.96 KB - PDF)
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svenska (SV) (159.03 KB - PDF)
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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: Reference Number: EMA/CHMP/302620/2017 Corr.1
English (EN) (803.95 KB - PDF)
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български (BG) (839.88 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
español (ES) (703.08 KB - PDF)
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čeština (CS) (820.69 KB - PDF)
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dansk (DA) (775.32 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
Deutsch (DE) (777.2 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
eesti keel (ET) (748.01 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
ελληνικά (EL) (851.84 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
français (FR) (796.79 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
hrvatski (HR) (817.47 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
íslenska (IS) (770.42 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
italiano (IT) (767.61 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
latviešu valoda (LV) (825.2 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
lietuvių kalba (LT) (826.31 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
magyar (HU) (830.38 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
Malti (MT) (804.36 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
Nederlands (NL) (774.1 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
norsk (NO) (769.45 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
polski (PL) (817.25 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
português (PT) (765.58 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
română (RO) (821.81 KB - PDF)
First published: 09/10/2017Last updated: 22/11/2019
slovenčina (SK) (818.86 KB - PDF)
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slovenščina (SL) (805.68 KB - PDF)
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Suomi (FI) (768.01 KB - PDF)
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svenska (SV) (745.16 KB - PDF)
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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:
to Draft: 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.
English (EN) (143.38 KB - PDF)
First published:
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
English (EN) (222.49 KB - PDF)
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Related content
- Excipients labelling
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- 2003 European Commission guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (In operation from 01/07/2003 to 01/03/2018)