Paragraph 2 Interpretation

For the purposes of these Regulations, a clinical trial authorisation is in force unless the licensing authority has—

(a)

received notification of the conclusion of the clinical trial to which the authorisation relates, in accordance with regulation 27 (conclusion of clinical trial) of the Clinical Trials Regulations; or

(b)

suspended or terminated the trial at all sites at which that clinical trial was conducted, in accordance with regulation 31 (suspension or termination of clinical trial) of those Regulations^f1.

Annotations

Footnotes

f1: Revocations and amendments to regulation 31 have been made by S.I. 2005/2754 and 2006/1928.