28HApplying for a mitochondrial donation licence

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 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.