Module 5 Presentations

05/07/2024

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CT Regulation Requirements

• GMP for IMP now in a single legal text as opposed to three Directives – Chapter 9 of Regulation – Art 61 MIA requirements – Art 62 QP declaration – Art 63 GMP for IMP – Art 64 Modification of authorised products – Art 65 Auxiliary medicinal products • GMP Directive 2003/94/EC applies until end of transition period for trials submitted under CT Directive 2001/20/EC

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