Research Involving Human Embryos Act 2002

A person may, subject to subsections (2) to (7), apply to the NHMRC Licensing Committee for:

a pre‑clinical research and training licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28C(2); or

a clinical trial research and training licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28D(2); or

a clinical trial licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28E(2); or

a clinical practice research and training licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28F(2); or

a clinical practice licence, relating to a permitted technique for such a licence, that authorises one or more of the activities referred to in subsection 28G(2).

A person cannot apply for any of the following licences unless the person is a constitutional corporation:

a pre‑clinical research and training licence;

a clinical trial research and training licence;

a clinical trial licence.

A person cannot apply for a clinical trial licence relating to a particular mitochondrial donation technique unless the person has held a clinical trial research and training licence relating to that technique.

A person cannot apply for a clinical practice licence relating to a particular mitochondrial donation technique unless the person has held a clinical practice research and training licence relating to that technique.

An application for a mitochondrial donation licence relating to a particular mitochondrial donation technique must nominate one or more embryologists who will be authorised to use the technique under the licence.

A single application cannot relate to:

more than one kind of mitochondrial donation licence; or

more than one permitted technique for a mitochondrial donation licence.

An application for a mitochondrial donation licence must:

be in the form approved by the NHMRC Licensing Committee; and

specify the following:

the kind of mitochondrial donation licence;

the permitted technique to which the licence will relate; and

be made in accordance with:

the requirements specified in the regulations for the purposes of this subparagraph (if any); and

such other requirements (if any) as are specified in writing by the NHMRC Licensing Committee and are not inconsistent with requirements specified under subparagraph (i); and

be accompanied by the fee (if any) prescribed by the regulations.

A form approved for the purposes of paragraph (7)(a) may require:

an application to contain, or be accompanied by, such information as is required by the form; and

any such information to be verified by statutory declaration.