Commonwealth Consolidated Acts

RESEARCH INVOLVING HUMAN EMBRYOS ACT 2002 - SECT 28H

  (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 require:

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

  (b)   any such information to be verified by statutory declaration.