Human Tissue and Transplant Act 1982
Human Tissue and Transplant Regulations 2024
Western Australia
Human Tissue and Transplant Regulations 2024
Contents
1.Citation1
2.Commencement1
3.Exempt entity (s. 29A(1))1
4.TGA provisions (s. 29A(4)(d) and (e))1
5.Tissue banks (s. 29B(1))1
6.Body of medical practitioners (s. 29E(3)(a))1
7.Human Tissue and Transplant Regulations 2006 repealed1
Defined terms
Human Tissue and Transplant Act 1982
Human Tissue and Transplant Regulations 2024
Made by the Governor in Executive Council.
These regulations come into operation as follows —
(a)regulations 1 and 2 — on the day on which these regulations are published on the WA legislation website;
(b)the rest of the regulations — on 19 February 2024.
For the purposes of the definition of exempt entity in section 29A(1), the Australian Bone Marrow Donor Registry (ACN 096 625 231) is an exempt entity.
4.TGA provisions (s. 29A(4)(d) and (e))
(1)In this regulation —
TGA provision has the meaning given in section 29A(1).
(2)For the purposes of section 29A(4)(d), the following TGA provisions are prescribed —
(a)the Therapeutic Goods Act section 19(1);
(b)the Therapeutic Goods Act section 19(5);
(c)a rule made under the Therapeutic Goods Act section 19(7A);
(d)the Therapeutic Goods Act section 32CK(1);
(e)the Therapeutic Goods Act section 32CM(1);
(f)a rule made under the Therapeutic Goods Act section 32CM(7A);
(g)the Therapeutic Goods Act section 41HB(1);
(h)the Therapeutic Goods Act section 41HC(1);
(i)a rule made under the Therapeutic Goods Act section 41HC(6).
(3)For the purposes of section 29A(4)(e), the following TGA provisions are prescribed —
(a)a regulation made for the purposes of the Therapeutic Goods Act section 18(1);
(b)the Therapeutic Goods Act section 18A(1);
(c)a regulation made for the purposes of the Therapeutic Goods Act section 32CA(2);
(d)the Therapeutic Goods Act section 32CB(1).
(4)A regulation referred to in subregulation (3)(a) or (c) is not prescribed for the purposes of section 29A(4)(e) to the extent that it applies to a therapeutic good mentioned in the Therapeutic Goods Regulations 1990 (Commonwealth) Schedule 5 item 10.
For the purposes of the definition of tissue bank in section 29B(1), the following facilities are tissue banks —
(a)the Perron Rotary Express Milk Bank (PREM Bank);
(b)the branch of Australian Red Cross Lifeblood responsible for donor human milk.
6.Body of medical practitioners (s. 29E(3)(a))
For the purposes of section 29E(3)(a), the Western Australian Kidney Transplant Society Medical Subcommittee is a body of medical practitioners.
7.Human Tissue and Transplant Regulations 2006 repealed
The Human Tissue and Transplant Regulations 2006 are repealed.
K. COLLERAN, Clerk of the Executive Council
[This is a list of terms defined and the provisions where they are defined. The list is not part of the law.]
Defined termProvision(s)
TGA provision4(1)
© State of Western Australia 2024. This work is licensed under a Creative Commons Attribution 4.0 International Licence (CC BY 4.0). To view relevant information and for a link to a copy of the licence, visit www.legislation.wa.gov.au. Attribute work as: © State of Western Australia 2024. By Authority: GEOFF O. LAWN, Government Printer