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Eudralex Volume 3 Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to Advanced therapy medicinal products


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Since ATMPs are very diverse in nature (i.e. gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (sCTMPs) and tissue engineering products (TEPs)), a flexible approach to address and evaluate potential risks associated with the clinical use of ATMPs is described in the 'Risk-based approach'.

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