Module 9 2021

EU relevant directive, guidelines and procedures

Scientific Guidelines Quality Pre-clinical Clinical

Follow up, Post Authorization & Risk management

Scientific advice Certification & Classification

ERA

RBA

Medicinal Products Community Code Dir. 2001/83/EC

Medicinal Products Centralised procedure Reg. (EC) 726/2004

ATMPs Regulation

‘Annex I’ 2009/120/EC

1394/2007/EC EC/688/2009

Tissues/Cells/Blood 2004/23/EC 2006/86/EC 2006/17/EC

Clinical Trials 2001/20/EC 536/2014/EC 2005/28EC ENTR/F/2/SF/dn D(2009) 35810

Variations 1084/2003/EC 1085/2003/EC 1234/2008/EC

GMP 2003/94/EC (C92017)7694

‘Annex I’ 2003/63/EC

2015/565/EC 2015/565/EC

Novartis Pharma AG- Business use only- not for further distribution

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