EMA: Update of the Annex to the Excipients Guideline

The EU Pharmaceutical Legislation Reform: Impact on the API Industry

Recommendation

21 October 2025
Barcelona, Spain

The EU Pharmaceutical Legislation Reform: Impact on the API Industry
An ECA Course prior to the 28th APIC/CEFIC Global GMP & Regulatory API Conference

In April 2024, the fourth revision of the Annex to the Guideline "Excipients in the labeling and package leaflet of medicinal products for human use" was published on the EMA website. The guideline, which has been available in the currently applicable version since March 2018, consists of the following chapters:

INTRODUCTION
PURPOSE
DEFINITIONS AND EXAMPLES
NOMENCLATURE
EXCIPIENTS IN THE LABELLING
EXCIPIENTS IN THE PACKAGE LEAFLET
ANNEX: EXCIPIENTS AND INFORMATION FOR THE PACKAGE LEAFLET

Now the annex "EXCIPIENTS AND INFORMATION FOR THE PACKAGE LEAFLET" has been revised again and the information for polysorbates has been listed. The substances are listed in the annex in tabular and alphabetical order and the corresponding texts for the package leaflet are given. Furthermore, additional comments as well as the type of application and the corresponding threshold values are listed together with the update date.

The current version of the guideline "Excipients in the labeling and package leaflet of medicinal products for human use" and the "ANNEX: EXCIPIENTS AND INFORMATION FOR THE PACKAGE LEAFLET" can be found on the EMA website.