Section 15: Amendment of trial licence
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.
15. Amendment of trial licence
(1) Where a sponsor, after having been issued with a trial licence, wishes
to amend the protocol or any other document submitted under section 12,
he shall make a written application to the Council in such form and manner
as may be prescribed, accompanied by the prescribed application fee.
(2) The Council shall refer any application made under subsection (1) to
the Ethics Committee for an opinion.
(3) The Council may, after consideration of the opinion of the Ethics
Committee, grant or refuse the application.
(4) On approving the application, the Council may, where it considers it
appropriate, issue an amended trial licence to the sponsor on such terms and
conditions as it thinks fit and on payment of the prescribed fee.
(5) No sponsor shall implement any amendment referred to in subsection (1) unless it is approved by the Council.