Regulation 8A
Definition of “serious adverse event”
of Human Biomedical Research Regulations 2017
Subsidiary LegislationIn forceProvision 9 of 37
Regulation 8A
The untoward medical occurrences which result in any of the following are prescribed events for the purposes of paragraph (a)(vi) of the definition of “serious adverse event” in section 2 of the Act:
(a)
the transmission of a communicable disease;
(b)
any misidentification or mix‑up of any type of human biological material, gamete or embryo.