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

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Current effective version

Adopted guideline

Reference numberCAT/CPWP/686637/2011
Published12/02/2013
Effective from12/02/2013
KeywordsAdvanced therapy medicinal products (ATMPs), risk-based approach, risk, risk factor
DescriptionThis 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.


Document history

First version

Current version

Adopted guideline


Draft guideline


Concept paper

In operation: 12/02/2013–present


Published: 24/01/2012


Published: 26/01/2010


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