Section 27: Record of adverse event or reaction
consolidated text (as at 2017, amended since). juris shows the text as it was consolidated; it does not confirm that this is the law in force today.
27. Record of adverse event or reaction
(1) A sponsor shall keep detailed records of any adverse event, serious
adverse event, adverse reaction or serious adverse reaction, which—
(a) arises during a clinical trial;
(b) comes to his knowledge from reports of similar clinical trials
conducted elsewhere; or
(c) is reported to him by the investigator.
(2) The sponsor shall submit the records referred to in subsection (1) to
the Council and Pharmacovigilance Committee on each anniversary of the
clinical trial or upon request by the Council or Pharmacovigilance Committee,
as the case may be.