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Four new public consultations concerning good manufacturing practices and clinical trials for human medicinal products were opened August 28, 2015 with
closing date November 24, 2015As a consequence of implementation of the Clinical Trial Regulation 536/2014:
Directive 2003/94/EC is repealed and replaced by– a “Delegated Act on principles and guidelines of GMP for IMPs”includes a link to GMP for Advanced Therapy IMPs
>> Synopsis Directive 2003/94/EC and Delegated Act
>> Template for your comments on delegated Act on principles and guidelines of GMP for IMPs
– a new “Implementing Directive on principles and guidelines of GMP for medicinal products for human use”,meaning that Dir 2003/94/EC is split into two new documents, one for IMPs and one for commercial MPs.
Advanced Therapies –
major developments“Good Manufacturing Practice for Advanced Therapy Medicinal Products”Consultation Document –
closing date November 12, 2015
>> Template for your comments on GMP for ATMPs
Annex 13 will be deleted from EudraLex Vol 4 when the new guidelines“Detailed Commission guidelines on GMP for IMPs for human use”
become operational, carrying over relevant principles of Annex 13
>> Synopsis of Annex 13
>> Template for your comments on detailed Commission guidelines on GMP for IMPs
Directive 2005/28/EC is repealedthe “Detailed arrangements for clinical trials inspection procedures including the qualification and training requirements for inspectors”
carries over to the extent possible the principles and guidance set out in
Chap 5 & 6 of Dir 2005/28/EC. Additional provisions are introduced to include
more detailed arrangements
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