Singapore legislation
Regulation 9
of Human Biomedical Research (Tissue Banking) Regulations 2019
Regulation 9
Notification under section 35(3)(a) of Act
Subregulation 1
For the purposes of section 35(3)(a) of the Act, a tissue bank must ensure that all relevant information (except for the information specified in paragraph (3)) required under that provision in relation to tissue banking activity conducted under the supervision and control of that tissue bank is —
recorded; and
submitted to the Director‑General as soon as possible and in any event not later than 7 days after the tissue bank or the principal person in charge designated first becomes aware of the information, whichever is the earlier.
Subregulation 2
The relevant information mentioned in paragraph (1) must be submitted to the Director‑General in the applicable form set out at the relevant website.
Subregulation 3
For the purposes of section 35(3)(a) of the Act, a tissue bank must ensure that relevant information relating to contraventions in relation to tissue banking activity conducted under the supervision and control of that tissue bank and that did not cause harm to and had no potential to cause harm to any tissue donor, is recorded and submitted to the Director‑General —
at the same time the declaration of compliance is submitted in accordance with regulation 8(3); and
on an annual basis aggregating the information in the applicable form set out at the relevant website.