Human Tissue and Transplant Regulations 2024 (WA)

Western Australia

Human Tissue and Transplant Act 1982

Human Tissue and Transplant Regulations 2024

Western Australia

Human Tissue and Transplant Regulations 2024 Contents Human Tissue and Transplant Act 1982

Human Tissue and Transplant Act 1982

Human Tissue and Transplant Regulations 2024

1.Citation

These regulations are the Human Tissue and Transplant Regulations 2024.

2.Commencement

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.

3.Exempt entity (s. 29A(1))

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.TG law provisions (s. 29A(4)(d) and (e))

• (1)

  In this regulation —

equivalent rule, in relation to a rule made under the Therapeutic Goods Act, means the rule that —

• (a)

  applies as a law of the State under the Therapeutic Goods Law Application Act 2024 section 10; and

• (b)

  is equivalent to the rule made under the Therapeutic Goods Act;

equivalent section, in relation to a section of the Therapeutic Goods Act, means the section of the Therapeutic Goods Act that —

• (a)

  applies as a law of the State under the Therapeutic Goods Law Application Act 2024 section 5; and

• (b)

  is equivalent to the section of the Therapeutic Goods Act;

TGA provision has the meaning given in section 29A(1);

TG law provision has the meaning given in section 29A(1).

• (2)

  For the purposes of section 29A(4)(d), the following TG law 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);

  • (j)

    the equivalent section of each section of the Therapeutic Goods Act prescribed under paragraphs (a), (b), (d), (e), (g) and (h);

  • (k)

    the equivalent rule of each rule made under the Therapeutic Goods Act prescribed under paragraphs (c), (f) and (i).

• (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.

[Regulation 4 amended: SL 2024/276 r. 4.]

5.Tissue banks (s. 29B(1))

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.

Notes

This is a compilation of the Human Tissue and Transplant Regulations 2024 and includes amendments made by other written laws. For provisions that have come into operation see the compilation table.

Compilation table

Citation	Published	Commencement
Human Tissue and Transplant Regulations 2024	SL 2024/10 9 Feb 2024	r. 1 and 2: 9 Feb 2024 (see r. 2(a)); Regulations other than r. 1 and 2: 19 Feb 2024 (see r. 2(b))
Human Tissue and Transplant Amendment Regulations 2024	SL 2024/276 18 Dec 2024	r. 1 and 2: 18 Dec 2024 (see r. 2(a)); Regulations other than r. 1 and 2: 19 Dec 2024 (see r. 2(b))

Defined terms

[This is a list of terms defined and the provisions where they are defined. The list is not part of the law.]

Defined term Provision(s)

equivalent rule............................................................................................................. 4(1)

equivalent section....................................................................................................... 4(1)

TGA provision............................................................................................................. 4(1)

TG law provision........................................................................................................ 4(1)