This document covers the MRL status for excipients. It answers questions on how to address excipients in relation to the marketing authorisation application in the light of Regulation (EEC) 2377/90.

Keywords: Consumer safety, excipients

Current effective version

Approaches on how to consider excipients in the context of Regulation 2377/90

Reference Number: EMEA/CVMP/223005/2005

English (EN) (40.3 KB - PDF)

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