Quality and Risk Management Group

Pharmaceutical excipients are constituents of a medicine that are not used for their direct therapeutic action, but to aid the manufacturing process, such as to enhance stability or bioavailability.

Patients may want or need to avoid certain pharmaceutical excipient(s) for a number of reasons. Medicines free from specific pharmaceutical excipient(s) may be requested for particular patient groups (e.g. neonates), patients with a severe allergy or with particular cultural or religious beliefs. This document aims to assist healthcare professionals in providing safe, effective and timely answers to support that decision. It outlines the steps involved in checking for the presence or absence of the substance in product information; and provides an explanation of the requirements for information about constituent excipients in the product labelling and patient information leaflet.

Attachments

• Handling Questions About Excipients · PDF · 599 KB