Singapore legislation
Regulation 23
of Human Biomedical Research (Tissue Banking) Regulations 2019
Regulation 23
Additional requirements before tissue is released, supplied or exported
Subregulation 1
In addition to the requirements in regulation 15, the written authorisation of the principal person in charge designated by a transplantational tissue bank must be obtained before any tissue may be —
removed from the supervision and control of that tissue bank;
supplied by that tissue bank; or
exported or otherwise removed from Singapore to a place outside Singapore.
Subregulation 2
Every transplantational tissue bank must ensure that the following information must be provided to the recipient of the human tissue supplied by that tissue bank for the purpose of research involving human tissue transplantation:
the source of the tissue;
the donor screening process and necessary tests performed to ensure product safety and compatibility;
any regulatory obligation imposed on the tissue bank as a result of the removal, supply or export of the tissue.
Subregulation 3
A transplantational tissue bank who or which contravenes paragraph (1) or (2) shall be guilty of an offence and shall be liable on conviction —
in the case of an individual, to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both; or (b)in any other case, to a fine not exceeding $20,000.