Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products

This document provides guidance on the application of the risk-based approach in the preparation of a marketing authorisation application. The concept of a 'Risk-based approach' has been introduced to the legislation with the revision of Annex 1, part IV of Directive 2001/83/EC as amended by Directive 2009/120 EC.

Keywords: Advanced therapy medicinal products (ATMPs), risk-based approach, risk, risk factor

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