Document ID: chunk:federal_register_of_legislation:C2022A00026:clause:1_28h:p1
Version: federal_register_of_legislation:C2022A00026
Segment Type: clause
Provision Reference: sch 1 cl 28H (pt 1/2)
Character Range: 25701–28567

28H  Applying for a mitochondrial donation licence
 (1) A person may, subject to subsections (2) to (7), apply to the NHMRC Licensing Committee for:
 (a) 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
 (b) 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
 (c) 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
 (d) 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
 (e) 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).
 (2) A person cannot apply for any of the following licences unless the person is a constitutional corporation:
 (a) a pre‑clinical research and training licence;
 (b) a clinical trial research and training licence;
 (c) a clinical trial licence.
 (3) 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.
 (4) 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.
 (5) 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.
 (6) A single application cannot relate to:
 (a) more than one kind of mitochondrial donation licence; or
 (b) more than one permitted technique for a mitochondrial donation licence.
 (7) An application for a mitochondrial donation licence must:
 (a) be in the form approved by the NHMRC Licensing Committee; and
 (b) specify the following:
 (i) the kind of mitochondrial donation licence;
 (ii) the permitted technique to which the licence will relate; and
 (c) be made in accordance with:
 (i) the requirements specified in the regulations for the purposes of this subparagraph (if any); and
 (ii) 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
 (d) be accompanied by the fee (if any) prescribed by the regulations.
 (8) A form approved for the purposes of paragraph (7)(a) may