5Application for medicinal cannabis licence—information requirements

5 Application for medicinal cannabis licence—information requirements

(1) For the purposes of paragraph 8E(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 medicinal cannabis licence. General information (2) The application must contain the following information: (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 8E(1) of the Act; (g) the following details relating to the location where the activities to be authorised by the licence will be undertaken: (i) the physical address or, if there is no physical address, the location expressed in geographic coordinates; (ii) the total area of land at the location and the area of that land that will be used for the activities; (iii) details of the premises and facilities at the location where the activities will be undertaken; (iv) the zoning of the land at the location; (v) the applicant’s legal right to use or occupy the premises at the location; (h) details of the measures that the applicant will take to ensure the following in relation to cannabis plants or cannabis drugs that are in the applicant’s possession or control and that are obtained, cultivated, produced or manufactured under, or purportedly under, the licence: (i) the physical security of the cannabis plants or cannabis drugs; (ii) the safety and security of the supply, delivery and transportation of the cannabis plants or cannabis drugs; (iii) the establishment of arrangements between the applicant and emergency services (including a police service or relevant local government authority) to deal with loss, theft, spoilage, disposal and destruction of the cannabis plants or cannabis drugs; (i) details of the measures that the applicant will take to ensure the suitability of persons employed or engaged by the applicant for the purposes of carrying out activities authorised by the licence; (j) if the applicant proposes to supply to a recipient cannabis plants cultivated, or cannabis or cannabis resin produced, under, or purportedly under, the licence—the purpose for which the cannabis plants, cannabis or cannabis resin are to be supplied; (k) if the applicant is seeking a decision of the Secretary under paragraph 54A(1)(c) that the activities that the applicant proposes to undertake under the licence will be undertaken for, or primarily for, medical or scientific research that is for a non‑commercial purpose—details of the following: (i) the primary purpose of the activities and research; (ii) who will benefit from the activities and research; (iii) how any products that may be developed as a result of the activities and research will be used; (iv) the source of the funds for the activities and research; (v) who owns and operates the facilities at which the activities and research are to be undertaken; (l) the name of each person who is to be authorised by the licence to engage in the activities authorised by the 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 whether the applicant is a fit and proper person to hold a licence; (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 whether the applicant is a fit and proper person to hold a licence; (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 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. Additional information required if applicant proposes to manufacture a cannabis drug (5) If the applicant proposes to manufacture a cannabis drug, the application must also contain the following: (a) if the drug is to be supplied for use in a clinical trial that is, or is likely to be, approved under the Therapeutic Goods Act 1989 or notified to the Secretary under that Act—information about the clinical trial in which the drug is to be used; (b) if the drug is to be supplied in accordance with an approval or authority under that Act—information about that approval or authority; (c) if the drug is to be supplied to a person who holds a licence under Part 3‑3 of that Act for use by that person in the manufacture of a medicine (within the meaning of that Act)—information about the licence and the holder of the licence; (d) if the drug is registered goods within the meaning of that Act—the number assigned to the registered goods on the Australian Register of Therapeutic Goods maintained under section 9A of that Act; (e) if the drug is to be supplied to a pharmacist in a public hospital for the purposes of the pharmacist dispensing the drug in accordance with that Act—information about the hospital; (f) if the drug is to be supplied for use in medical or scientific research where that research is not a clinical trial referred to in paragraph (a) and does not involve the drug being administered to humans—information about the research including the name of the entity undertaking the research; (g) if the drug is to be supplied for use as a reference standard for medical or scientific testing purposes—information about the proposed use of the reference standard; (h) if the drug is to be supplied for export from Australia in accordance with a licence and permission under the Customs (Prohibited Exports) Regulations 1958—information about the licence and permission; (i) if the drug is to be supplied to a person who holds a medicinal cannabis licence that authorises the manufacture of a cannabis drug—information about the licence and the holder of the licence.