30.—(1) The sponsor and investigator may take appropriate urgent safety measures in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety.
[F1(2) If measures are taken pursuant to paragraph (1), the sponsor shall—
(a)where paragraph (3) applies, as soon as possible; and
(b)in any other case, immediately, and in any event no later than 3 days from the date the measures are taken,
give written notice to the licensing authority and the relevant ethics committee of the measures taken and the circumstances giving rise to those measures.
(3) This paragraph applies for any period during which a disease—
(a)is pandemic; and
(b)is a serious risk to human health or potentially a serious risk to human health.]
Textual Amendments
F1Reg. 30(2)(3) substituted for reg. 30(2) (8.5.2009) by The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009 (S.I. 2009/1164), regs. 1, 3