Document ID: chunk:federal_register_of_legislation:F2024C00525:reg:35:p1
Version: federal_register_of_legislation:F2024C00525
Segment Type: reg
Provision Reference: reg 35 (pt 1/4)
Character Range: 75844–78643

35  Application for manufacture licence—information requirements
 (1) For the purposes of paragraph 11G(2)(a) of the Act, the information specified in this section is prescribed in relation to an application by a person (the applicant) for a manufacture licence.

General information
 (2) The application must contain the following:
 (a) the name of the applicant;
 (b) if the applicant is a natural person—the applicant's date of birth;
 (c) if the applicant is a body corporate—the applicant's ACN, ABN or ARBN;
 (d) the applicant's mailing address and email address;
 (e) a telephone contact number for the applicant;
 (f) details of the activities the applicant proposes to undertake under the licence, being activities mentioned in subsection 11G(1) of the Act;
 (g) details of the narcotic drug proposed to be manufactured;
 (h) details of the proposed end use of the manufactured narcotic drug;
Note: End use may, for example, include export, use in research, supply for clinical trials, manufacture of other drugs or supply to patients in accordance with State or Territory laws.
 (i) the following details of the location where the activities will be undertaken under the manufacture licence:
 (i) the address of the premises at which the narcotic drug will be manufactured;
 (ii) the address of the premises at which other activities relating to such manufacture will be undertaken;
 (iii) the total area, and geographic coordinates, of the land at the location;
 (iv) details of the premises and facilities at the location where the activities will be undertaken;
 (v) whether the premises are owned or leased by the applicant and, if leased, the name and address of the landlord;
 (vi) details of how access will be provided to the premises and facilities at the location for the purposes of the Secretary inspecting the premises and facilities;
 (j) details of the measures that the applicant will take to ensure the physical security of the narcotic drug or starting material in relation to such a drug:
 (i) in the applicant's possession or control; and
 (ii) manufactured under, or purportedly under, the licence;
 (o) whether the applicant has applied, or proposes to apply, for any other licence under the Act and, if so, the kind of licence.

Information about whether applicant is a fit and proper person—natural persons
 (3) If the applicant is a natural person, the application must also contain the following information:
 (a) details of any conviction, at any time, of the applicant for an offence against a law of the Commonwealth, a State, a Territory or another country;
 (b) details of any civil penalty (however described) imposed, at any time, upon the applicant under a law of the Commonwealth, a State or a Territory;
 (c) details of any revocation or suspension of a