Spring Intro 2023

Excipient guideline - leaflets

Details information to be included in PIL for those excipients declared on labelling

All excipients must be declared in leaflet (section 6) including:-

- transdermal patch constituents

- constituents of capsule shell, film coat, polish, printing inks

- pH adjusters, diluents, and preservatives

The relevant excipient warnings (for those of known effect) should be presented at the end of section 2 of the leaflet.

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Readability guideline

• Primary objective is to provide guidance on how to ensure that the information on the labelling and package leaflet is accessible to and can be understood by those who receive it, so that they can use their medicine safely (published January 2009)

• Can be accessed at: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol2/c/2009_01_12_readability_guideline_final.pdf

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