to things done, or omitted to be done, by constitutional corporations;

to things done, or omitted to be done, in the course of constitutional trade or commerce;

to matters within the legislative power of the Commonwealth under paragraph 51(xxix) of the Constitution;

to the Commonwealth and Commonwealth authorities;

for purposes relating to the collection, compilation, analysis and dissemination of statistics;

to matters within the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection.

between and places outside ; or

among the States; or

by way of the supply of services to the Commonwealth or to a Commonwealth authority.

a human embryo into which a cell, or any component part of a cell, of an animal has been introduced; or

a thing declared by the regulations to be a chimeric embryo.

Commonwealth authority means the following: a body corporate established for a public purpose by or under an Act; a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together: the Commonwealth; a body covered by paragraph (a); a body covered by either of the above subparagraphs.

a body corporate established for a public purpose by or under an Act;

a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:

the Commonwealth;

a body covered by paragraph (a);

a body covered by either of the above subparagraphs.

excess ART embryo means a human embryo that: was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and is excess to the needs of: the woman for whom it was created; and her spouse (if any) at the time the embryo was created.

was created, by assisted reproductive technology, for use in the assisted reproductive technology treatment of a woman; and

is excess to the needs of:

the woman for whom it was created; and

her spouse (if any) at the time the embryo was created.

general licence has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.

human embryo means a discrete entity that has arisen from either: the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears; and has not yet reached 8 weeks of development since the first mitotic division.

the first mitotic division when fertilisation of a human oocyte by a human sperm is complete; or

any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears;

and has not yet reached 8 weeks of development since the first mitotic division.

human embryo clone means a human embryo that is a genetic copy of another living or dead human, but does not include a human embryo created by the fertilisation of a human egg by human sperm.

human sperm includes human spermatids.

hybrid embryo means:

an embryo created by the fertilisation of a human egg by animal sperm; or

an embryo created by the fertilisation of an animal egg by human sperm; or

a human egg into which the nucleus of an animal cell has been introduced; or

an animal egg into which the nucleus of a human cell has been introduced; or

a thing declared by the regulations to be a hybrid embryo.

mitochondrial donation licence means any of the following licences issued under section 28J of the Research Involving Human Embryos Act 2002: a pre-clinical research and training licence; a clinical trial research and training licence; a clinical trial licence; a clinical practice research and training licence; a clinical practice licence.

a pre-clinical research and training licence;

a clinical trial research and training licence;

a clinical trial licence;

a clinical practice research and training licence;

a clinical practice licence.

mitochondrial donation technique has the same meaning as in Part 2 of the Research Involving Human Embryos Act 2002.

NHMRC Licensing Committee means the Committee established under section 13 of the Research Involving Human Embryos Act 2002.

precursor cell means a cell that has the potential to develop into a human egg or human sperm.

spouse includes a de facto partner of the person within the meaning of the Acts Interpretation Act 1901.

State includes the and the .

woman means a female human.

it is sufficient to establish that the set of genes in the nuclei of the cells of the living or dead human has been copied; and

it is not necessary to establish that the copy is an identical genetic copy.

each such person has given written authority for use of the embryo for a purpose other than a purpose relating to the assisted reproductive technology treatment of the woman concerned, and the authority is in force at that time; or

each such person has determined in writing that the embryo is excess to their needs, and the determination is in force at that time.

a hybrid embryo; or

a human embryonic stem cell line.

the person’s intention in creating the embryo is to attempt to achieve pregnancy in a particular woman;

(b) the creation of the embryo by the person is permitted under Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).section 28B of the

the person alters the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered; and

in altering the genome, the person intended the alteration to be heritable by descendants of the human whose cell was altered; and

(c) the alteration of the genome by the person is not permitted under Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).section 28B of the

the embryo is a prohibited embryo under paragraph (a), (c) or (f) of the definition of that expression in subsection (4); and

(b) the placement of the embryo by the person is permitted under Research Involving Human Embryos Act 2002 (carrying out activities authorised by mitochondrial donation licences).section 28B of the

a human embryo created by a process other than the fertilisation of a human egg by human sperm; or

a human embryo created outside the body of a woman, unless the intention of the person who created the embryo was to attempt to achieve pregnancy in a particular woman; or

a human embryo that contains genetic material provided by more than 2 persons; or

a human embryo that has been developing outside the body of a woman for a period of more than 14 days, excluding any period when development is suspended; or

a human embryo created using precursor cells taken from a human embryo or a human fetus; or

a human embryo that contains a human cell (within the meaning of section 15) whose genome has been altered in such a way that the alteration is heritable by human descendants of the human whose cell was altered; or

a human embryo that was removed from the body of a woman by a person intending to collect a viable human embryo; or

a chimeric embryo or a hybrid embryo.

in relation to the supply of a human egg or human sperm—includes, but is not limited to, expenses relating to the collection, storage or transport of the egg or sperm; and

in relation to the supply of a human embryo:

does not include any expenses incurred by a person before the time when the embryo became an excess ART embryo; and

includes, but is not limited to, expenses relating to the storage or transport of the embryo.

valuable consideration, in relation to the supply of a human egg, human sperm or a human embryo by a person, includes any inducement, discount or priority in the provision of a service to the person, but does not include the payment of reasonable expenses incurred by the person in connection with the supply.

for the purposes of testing sperm quality in an accredited ART centre—up to, but not including, the first mitotic division; or

in the case of hybrid embryo created by introducing the nucleus of a human cell into an animal egg—for not longer than 14 days.

the conduct by the person is purportedly authorised by a provision of a general licence or a mitochondrial donation licence; and

the licence or the provision is invalid, whether because of a technical defect or irregularity or for any other reason; and

the person did not know, and could not reasonably be expected to have known, of the invalidity of the licence or the provision.

for a general licence—an offence against section 22, 23, 23A or 23B; or

for a mitochondrial donation licence—an offence against section 12, 13 or 15, subsection 20(3), or section 22 or 23.

mitochondrial donation licence includes a purported mitochondrial donation licence.