Spring Intro 2023

EC and UK Guidelines

Provision made in Article 65 of Directive 2001/83/EC and to which national legislation refers

• Excipients

• Readability

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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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