CRED SMPC 2024

Excipient guideline - labels

Details excipients to be declared on labelling (revised July 2022)

• All excipients must be declared on the labelling of injectable, topical, eye preparation and inhaled medicines

• Excipients of known effect must be declared on the labelling of all other medicines

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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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