Excipients labelling

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The European Medicines Agency (EMA) publishes background documents on excipients for inclusion in the label and package leaflet of human medicines.

An excipient is a constituent of a medicine other than the active substance.

Following the European Commission decision to revise the Annex of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1), EMA set up the CHMP Excipients Drafting Group (ExcpDG) in 2011.

Its objective is to update the labelling of selected excipients listed in the Annex of the above mentioned European Commission guideline, as well as to add new excipients to the list, as explained in a concept paper published in March 2012. 

The ExcpDG is a multidisciplinary group consisting of the Safety Working Party (SWP), the Quality Working Party (QWP), the Paediatric Committee (PDCO), the Pharmacovigilance Risk Assessment Committee (PRAC), the Coordination Group for Mutual Recognition and Decentralised Procedures - Human CMD(h) and the Vaccines Working Party (VWP).

It works in close collaboration with the Working Group on Quality Review of Documents (QRD). Other working parties or groups can also contribute, such as the Patients' and Consumers' Working Party (PCWP), the Healthcare Professionals' Working Party (HCWP), the Biologics Working Party (BWP) the Blood Products Working Party (BPWP) and the Committee on Herbal Medicinal Products (HMPC). 

As of 2016, the ExcpDG prepares a single report for each excipient under review consisting of scientific background review and the updated information for the package leaflet. EMA progressively releases these reports for public consultation. Previously, the ExcpDG consulted on a questions-and-answers (Q&As) document for each excipient, and prepared a separate background scientific report where relevant.

Once the Committee for Medicinal Products for Human Use (CHMP) has adopted the final updated package leaflet information for one or a group of excipient(s), the European Commission will include them in all EU languages in the Annex of the excipients guideline and will publish the guideline with the revised Annex. EMA will publish the final documents on this webpage and the European Commission will include them in the relevant section of Eudralex.

Table of contents


Reference documents

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Document(s) Language Status First published Last updated Effective Date
Excipients in the label and package leaflet of medicinal products for human use ES = español adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use CS = čeština adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use DA = dansk adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use DE = Deutsch adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use ET = eesti keel adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use EL = elliniká adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use EN = English adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use FR = français adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use IT = italiano adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use LV = latviešu valoda adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use LT = lietuvių kalba adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use HU = magyar adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use MT = Malti adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use NL = Nederlands adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use PL = polski adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use PT = português adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use SK = slovenčina adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use SL = slovenščina adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use FI = suomi adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use SV = svenska adopted 01/07/2003    
Excipients in the label and package leaflet of medicinal products for human use HR = Hrvatski adopted 01/07/2003    

Aspartame

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Benzalkonium chloride

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on benzalkonium chloride in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (English only) draft: consultation closed 30/06/2014    

Benzoic acid and Benzonates

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on Benzoic acid and Benzoates in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (English only) draft: consultation closed 24/02/2014    

Benzyl alcohol

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on Benzyl alcohol in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (English only) draft: consultation closed 24/02/2014    

Boric acid

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Cyclodextrins

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Ethanol

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on Ethanol in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (English only) draft: consultation closed 24/02/2014    

Fragrance allergens

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Fructose and sorbitol

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Propylene glycol and esters

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Sodium

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Document(s) Language Status First published Last updated Effective Date
Draft questions and answers on sodium in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (English only) draft: consultation closed 24/06/2015    

Sodium laurilsulfate

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Wheat starch (containing gluten)

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Document(s) Language Status First published Last updated Effective Date
Questions and answers on wheat starch containing gluten in the context of the revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (English only) draft: consultation closed 01/08/2014    

Reference information

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