Definition of substances capable of pharmacological action in the context of Council Directive 2001/82/EC as amended, with particular reference to excipients and manufacturing materials - Scientific guideline

This document aims to clarify the approach to be taken for excipients and manufacturing materials with regard to the establishment of MRLs.

Keywords: Consumer safety, pharmacological activity, excipients

Current effective version

Revised position paper on the definition of substances capable of pharmacological action in the context of council directive 2001/82/EC, as amended, with particular reference to excipients and manufacturing materials

Adopted Reference Number: EMEA/CVMP/072/97/Rev1 Legal effective date: 01/08/2004