Recommendation on the assessment of the quality of medicinal products containing existing/known active substances

Table of contents

This document applies to human and veterinary medicines.

Keywords Quality, assessment, impurities
Description This document is intended for assessors and addresses the strategy for the assessment of the quality of medicinal products containing existing/known active substances. It is not intended to give detailed guidance to the applicant, what information has to be submitted in an application file for marketing authorisation. This paper only deals with active substances and corresponding products of chemical origin. Biological/biotech and herbal products are excluded from the scope.

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