Edit Reference: Reference:GBR Directive 2001/20/EC 04-Apr-2001 Article 10 (b)-002

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Comment:	Repeated entry: 5.4.1 ++ 5.4.3 Member State authority to suspend or restrict a clinical trial (repeated)
Content:	Conduct of a clinical trial […] (b)without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating to the conduct of the trial or the development of the investigational medicinal product where that new event is likely to affect the safety of the subjects, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects against any immediate hazard. The sponsor shall forthwith inform the competent authorities of those new events and the measures taken and shall ensure that the Ethics Committee is notified at the same time;

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