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Determinations/Health as made
This determination specifies goods that are excluded for the purposes of the Therapeutic Goods Act 1989, principally human cells and tissue products in certain circumstances.
Administered by: Health
Made 15 Jun 2018
Registered 18 Jun 2018
Tabled HR 19 Jun 2018
Tabled Senate 20 Jun 2018

Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018

Therapeutic Goods Act 1989

I, LARRY KELLY, a delegate of the Minister for Health for the purposes of section 7AA of the Therapeutic Goods Act 1989 (the Act) and acting under subsection 7AA(2) of the Act, make the following determination specifying goods that are excluded goods for the purposes of the Act.

Dated  15  June 2018

(signed by)

LARRY KELLY

Delegate of the Minister for Health


1            Name of Determination

This Determination is the Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018.

2            Commencement

          This Determination commences on 1 July 2018.

3            Authority

            This Determination is made under subsection 7AA(2) of the Therapeutic Goods Act 1989.

4            Goods that are excluded goods

          The following specified goods, being goods intended for use in humans, are excluded goods for the purposes of the Therapeutic Goods Act 1989:

(a)    Therapeutic goods in relation to which the following apply:

(i)                 the goods comprise, contain or are derived from human cells or human tissues collected from a patient who is under the clinical care of a medical or dental practitioner;

(ii)               the goods were manufactured by, or under the professional supervision of, the practitioner in a hospital in a State or internal Territory for that patient who must be a patient of that hospital;

(iii)             the practitioner is registered in a State or internal Territory;

(iv)             the goods are not advertised directly to consumers;

(b)   fresh viable human organs, or parts of human organs, for direct donor-to- host transplantation and used in accordance with applicable laws and standards;

(c)    fresh viable human haematopoietic progenitor cells for direct donor-to-host transplantation for the purpose of haematopoietic reconstitution;

(d)   reproductive tissue for use in assisted reproductive therapy.