Document ID: chunk:federal_register_of_legislation:C2016A00012:clause:1_11g
Version: federal_register_of_legislation:C2016A00012
Segment Type: clause
Provision Reference: sch 1 cl 11G
Character Range: 75066–76390

11G  Person may apply for a manufacture licence
 (1) A person may apply to the Secretary for a licence (a manufacture licence) that authorises one or more of the following activities:
 (a) the manufacture of a drug in accordance with one or more manufacture permits;
 (b) activities relating to such manufacture, including but not limited to the following (as applicable):
 (i) the supply of the drug;
 (ii) the packaging, transport, storage, possession and control of the drug;
 (iii) the disposal or destruction of the drug.
 (2) The application must be made in the form or manner approved in writing by the Secretary, and must:
 (a) contain the information (if any) prescribed by the regulations; and
 (b) contain the information (if any) specified in writing by the Secretary; and
 (c) be accompanied by the documents (if any) prescribed by the regulations; and
 (d) be accompanied by the documents (if any) specified in writing by the Secretary.
Note: The Secretary may also require additional information and documents from the applicant at any time: see subsection 14J(1).
 (3) The application must be accompanied by the application fee (if any) prescribed by the regulations.
 (4) The application may be withdrawn at any time before a decision is made on the application, but the application fee is not refundable.