35Application for manufacture licence—information requirements

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 licence or permit (however described) held by the applicant under a law of the Commonwealth, a State, a Territory or another country, being a law relating to the prohibition or regulation of drugs; (d) details of the connections and associations that the applicant has with other persons (each of whom is a connected person) (including but not limited to the applicant’s relatives) that may affect the applicant’s reputation, character, honesty or professional or personal integrity; (e) the following details in relation to each connected person who is a natural person: (i) the name and date of birth of the person; (ii) the length of the connection or association with the person; (iii) the nature of the connection or association; (ea) the following details in relation to each connected person that is a body corporate: (i) the name of the body corporate; (ii) the body corporate’s ACN (if any); (iii) the body corporate’s ABN (if any); (iv) the body corporate’s ARBN (if any); (v) the length of the connection or association with the body corporate; (vi) the nature of the connection or association; (f) the name and date of birth of each natural person who holds a relevant financial interest, or who is entitled to exercise a relevant power (whether in the natural person’s own right or on behalf of another person): (i) in relation to the applicant’s business that will undertake the activities; or (ii) in relation to any other business of the applicant that provides a substantial proportion of the applicant’s current income; (fa) the name, ACN (if any), ABN (if any) and ARBN (if any) of each body corporate that holds a relevant financial interest, or that is entitled to exercise a relevant power (whether in the body corporate’s own right or on behalf of another person): (i) in relation to the applicant’s business that will undertake the activities; or (ii) in relation to any other business of the applicant that provides a substantial proportion of the applicant’s current income; (g) the following information in relation to each person who holds any relevant position (whether in his or her own right or on someone else’s behalf) in relation to the applicant’s business that will undertake the activities: (i) the name and date of birth of the person; (ii) the position in the business held by the person; (h) details of the applicant’s previous business experience; (l) details of any matters that may affect whether the applicant is of good repute, being matters going to the applicant’s character, honesty and professional and personal integrity; (m) details of any licence that the applicant holds, or has previously held, under the Act. Information about whether applicant is a fit and proper person—bodies corporate (4) If the applicant is a body corporate, the application must also contain the following information: (a) details of any conviction, at any time, of the body corporate, or any of its directors or officers, 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 body corporate, or any of its directors or officers, under a law of the Commonwealth, a State or a Territory; (c) if there is such a conviction or imposition of a civil penalty upon the body corporate: (i) whether the offence concerned was committed, or the conduct to which the civil penalty relates occurred, at a time when any person who is presently a director or officer of the body corporate was a director or officer; and (ii) whether the offence concerned was committed, or the conduct to which the civil penalty relates occurred, at a time when any shareholder of the body corporate who is presently in a position to influence the management of the body corporate was such a shareholder; (d) details of any revocation or suspension of a licence or permit (however described) held by the body corporate under a law of the Commonwealth, a State, a Territory or another country, being a law relating to the prohibition or regulation of drugs; (e) the names, and dates of birth, of the directors and officers of the body corporate; (f) details of the connections and associations that the body corporate, and its directors and officers, have with other persons (each of whom is a connected person) (including but not limited to the relatives of such directors and officers) that may affect the reputation, character, honesty or professional or personal integrity of such directors and officers; (g) the following details in relation to each connected person who is a natural person: (i) the name and date of birth of the person; (ii) the length of the connection or association with the person; (iii) the nature of the connection or association; (ga) the following details in relation to each connected person that is a body corporate: (i) the name of that body corporate; (ii) that body corporate’s ACN (if any); (iii) that body corporate’s ABN (if any); (iv) that body corporate’s ARBN (if any); (v) the length of the connection or association with that body corporate; (vi) the nature of the connection or association; (gb) the name and date of birth of each natural person who holds a relevant financial interest, or who is entitled to exercise a relevant power (whether in the natural person’s own right or on behalf of another person): (i) in relation to the applicant’s business that will undertake the activities; or (ii) in relation to any other business of the applicant that provides a substantial proportion of the applicant’s current income; (gc) the name, ACN (if any), ABN (if any) and ARBN (if any) of each body corporate that holds a relevant financial interest, or that is entitled to exercise a relevant power (whether in the body corporate’s own right or on behalf of another person): (i) in relation to the applicant’s business that will undertake the activities; or (ii) in relation to any other business of the applicant that provides a substantial proportion of the applicant’s current income; (gd) the following information in relation to each person who holds any relevant position (whether in his or her own right or on someone else’s behalf) in relation to the applicant’s business that will undertake the activities: (i) the name and date of birth of the person; (ii) the position in the business held by the person; (h) details of the previous business experience of the directors and officers of the body corporate, and of the shareholders of the body corporate who are presently in a position to influence the management of the body corporate; (k) details of any matters that may affect whether the directors and officers of the body corporate are of good repute, being matters going to their character, honesty and professional and personal integrity; (l) the body corporate’s history of compliance with the Act.