ABN has the meaning given by section 41 of the A New Tax System (Australian Business Number) Act 1999.
ACN has the meaning given by section 9 of the Corporations Act 2001.
Act means the Narcotic Drugs Act 1967.
ARBN has the meaning given by section 9 of the Corporations Act 2001.
commercial medicinal cannabis licence: see subsection 54A(4).
drug related offence means an offence against a law of the Commonwealth, a State or a Territory that:
(a) does not involve the cultivation of, or trafficking in, drugs but involves any of the following:
(i) the manufacture, supply, possession or use, of drugs;
(ii) the possession of equipment or instructions for the manufacture of drugs; and
(b) is punishable by:
(i) a monetary penalty of any amount; or
(ii) a maximum penalty of imprisonment for not less than 12 months.
licence variation type 1 means an application made under section 10N of the Act for a variation of a medicinal cannabis licence to:
(a) vary the name of the person who is the licence holder, but only if the legal entity that is the licence holder does not change; or
(b) vary or remove any one or more of the following:
(i) the name;
(ii) the description under paragraph 7B(a), (b) or (c) of this instrument;
(iii) any other description;
of a particular person authorised by the licence to engage in activities authorised by the licence.
Note: Example 1: A person who applies to vary the name of a particular person, and vary the description under paragraph 7B(a), (b) or (c) of that person, is required to pay the relevant fee once (see subsection 24(3)).
Note: Example 2: A person who applies to vary a particular person’s name, and vary the description under paragraph 7B(a), (b) or (c) of a different person, is required to pay the relevant fee twice (see subsection 24(4)).
Part Part 2 - Narcotic Drugs Regulation 2016 - Medicinal cannabis licences and permits | Zoe
licence variation type 2 means an application made under section 10N of the Act for a variation of a medicinal cannabis licence to:
(a) vary or add the period for which the licence is in force; or
(b) vary, add or remove, for a particular licensed premises, any one or more measures relating to the system of security that:
(i) was approved for the grant of the licence; or
(ii) was varied after the licence was granted; or
(c) make any other variation that is not specified in:
(i) paragraph (a) or (b); or
(ii) the definitions of licence variation type 1, licence variation type 3 or licence variation type 4.
Note: Example: A person who applies to vary, for a particular licensed premises, a measure relating to the system of security that was approved for the grant of the licence, and add a measure relating to the system of security for a different licensed premises, is required to pay the relevant fee twice (see subsection 24(4)).
licence variation type 3 means an application made under section 10N of the Act for a variation of a medicinal cannabis licence to:
(a) vary the site plan for a particular licensed premises where activities authorised by the licence are undertaken; or
(b) vary one or more floor plans of facilities at a particular licensed premises where activities authorised by the licence are undertaken, unless the variation is required as a result of varying, adding or removing an activity that is authorised by the licence at that licensed premises; or
(c) vary, add or remove a particular activity that is to be authorised by the licence at a particular licensed premises; or
(d) add the name of a particular person to be authorised by the licence to engage in activities authorised by the licence at any one or more licensed premises at which the licence authorises activities to be undertaken.
Note: For the meaning of licensed premises, see section 4 of the Act.
Note: Example: A person who applies to add an activity to be authorised by a licence, and to vary a different activity that is authorised by the licence, is required to pay the relevant fee twice (see subsection 24(4)).
licence variation type 4 means an application made under section 10N of the Act for a variation of a medicinal cannabis licence to add a particular licensed premises at which activities authorised by the licence are to be undertaken (including any other variations to the licence that are required as a result of adding the new licensed premises).
Note: Examples of other variations that may be required include adding a site plan or floor plan that relates to the new licensed premises, or adding activities that are authorised at the new licensed premises.
medicare card has the meaning given by subsection 84(1) of the National Health Act 1953.
non‑commercial medicinal cannabis licence: see subsection 54A(1).
permit variation type 1 means an application made under section 10N of the Act for a variation of a medicinal cannabis permit to:
(a) vary the name of the person who is the holder of the licence to which the permit relates, but only if the legal entity that is the licence holder does not change; or
(b) vary any one or more of the following:
(i) the maximum number of cannabis plants;
(ii) the maximum units of seeds;
(iii) the maximum quantity of cultivars or genetic material of a cannabis plant;
(iv) the maximum quantity of cannabis, cannabis resin or cannabis drug;
that the holder of the licence to which the permit relates may have in their possession or control at any time, but only if the variation does not result in an increase to the total number, units or quantity that the licence holder is authorised to obtain, cultivate, produce or manufacture during the period of the permit.
permit variation type 2 means an application made under section 10N of the Act for a variation of a medicinal cannabis permit to add or remove a particular supply pathway specified by the permit.
permit variation type 3 means an application made under section 10N of the Act for a variation of a medicinal cannabis permit to:
(a) vary any one or more of the following:
(i) the types of cannabis plants;
(ii) the total number of cannabis plants;
(iii) the total units of seeds;
(iv) the total quantity of cultivars or genetic material of a cannabis plant;
(v) the total quantity of cannabis, cannabis resin or cannabis drug;
that the licence holder is authorised to obtain, cultivate, produce or manufacture during the period of the permit; or
(b) vary, add or remove a particular activity that is specified by the permit to be undertaken at the relevant licensed premises.
Note: Example: A person who applies to add an activity to be specified by the permit, and to vary a different activity that is already specified by the permit, is required to pay the relevant fee twice (see subsection 24(4)).
starting material, in relation to a cannabis or narcotic drug, means a drug used in the manufacture of the cannabis or narcotic drug.
supply pathway means an arrangement to supply cannabis plants, cannabis, cannabis resin, or cannabis drug that is:
(a) required by the Act; or
(b) otherwise specified by a medicinal cannabis licence or medicinal cannabis permit.
4A Prescription of substances
For the purposes of paragraph (a) of the definition of drug in subsection 4(1) of the Act, the following substances are prescribed:
(a) tetrahydrocannabinol (including all isomers, salts and acids);
(c) dronabinol.
4B Permitted supply
For the purposes of paragraph (e) of the definition of permitted supply in subsection 4(1) of the Act, the following circumstances are prescribed:
(a) the supply of a cannabis drug to a pharmacist in a public hospital for the purposes of that pharmacist dispensing the drug in accordance with the Therapeutic Goods Act 1989;
(b) the supply of a cannabis drug for export from Australia in accordance with a licence and permission under the Customs (Prohibited Exports) Regulations 1958;
(ba) the supply of a cannabis drug to a person for the purposes of that person supplying an extemporaneously‑compounded medicinal cannabis product (within the meaning of the Therapeutic Goods Regulations 1990) in accordance with the Therapeutic Goods Act 1989;
(c) the supply of a cannabis drug to a person who holds a licence under Part 3‑3 of the Therapeutic Goods Act 1989 for use by that person in the manufacture of a medicine (within the meaning of that Act);
(d) the supply of a cannabis drug that is registered goods within the meaning of the Therapeutic Goods Act 1989;
(e) the supply of a cannabis drug to a person who holds a medicinal cannabis licence that authorises the manufacture of a cannabis drug.
Part 2—Medicinal cannabis licences and permits
Division 1—Medicinal cannabis licences and permits
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.
Note: A person may commit an offence if the person provides false or misleading information (see section 137.1 of the Criminal Code).
6 Application for medicinal cannabis licence—document requirements
(1) For the purposes of paragraph 8E(2)(c) of the Act, the documents specified in this section are prescribed as the documents that must accompany an application by a person (the applicant) for a medicinal cannabis licence.
(2) The following documents must accompany the application:
(ab) a current and historical company extract search of the records of the Australian Securities and Investments Commission in relation to the applicant, that is carried out no more than 30 days before the application is made;
(b) documents that provide evidence that the applicant has a sound and stable financial background and is not in financial circumstances that may significantly limit the applicant’s capacity to comply with the applicant’s obligations under a licence;
Note: Such documents could include, for example, bank statements or audited financial statements.
(c) a site plan for the location where the activities to be authorised by the licence will be undertaken showing how the land at the location will be used;
(d) a detailed floor plan of the facilities at the location where the activities to be authorised by the licence will be undertaken;
(e) a copy of the standard operating procedures and policies that deal with the following matters in relation to the location where the activities to be authorised by the licence will be undertaken:
(i) the measures to be used to prevent unauthorised access (physical and electronic);
(ii) the equipment to be used to prevent, monitor, detect and record unauthorised access;
(iii) the measures to be used for physical security at the location;
(f) such documents as are necessary to establish the applicant’s legal right to use or occupy the premises where the activities to be authorised by the licence will be undertaken.
Note: A person may commit an offence if the person provides false or misleading documents (see section 137.2 of the Criminal Code).
7 Application fee for medicinal cannabis licences
For the purposes of subsection 8E(3) of the Act, the application fee set out in the table in clause 1 of Schedule 1 for a medicinal cannabis licence is prescribed.
7A Application for medicinal cannabis licence—general grounds for refusal of licence
For the purposes of paragraph 8G(1)(f) of the Act, a circumstance in which a medicinal cannabis licence must not be granted is that the applicant for the licence is reasonably likely:
(a) not to be a resident of Australia; and
(b) not to carry on business in Australia;
at a time when the licence is proposed to be in force.
7B Matters to be specified in a medicinal cannabis licence—persons prescribed
For the purposes of paragraph 8M(e) of the Act, the following persons are prescribed as persons who are authorised by a medicinal cannabis licence to engage in the activities authorised by the licence:
(a) the licence holder;
(b) the person who holds a managerial or supervisory position that has direct control over the activities authorised by the licence;
(c) the person responsible for controlling on a daily basis the activities authorised by the licence.
8 Application for medicinal cannabis permit—information requirements
(1) For the purposes of paragraph 8P(2)(a) of the Act, the information specified in this section is prescribed in relation to an application by the holder of a medicinal cannabis licence (the applicant) for a medicinal cannabis permit.
General information
(2) The application must contain the following information:
(a) the name of the applicant;
(b) the licence number of the medicinal cannabis licence held by the applicant;
(c) the activities that are proposed to be authorised by the licence in accordance with the permit;
(d) the period for which the permit would need to be in force;
(e) details of how access will be provided to the premises at which activities authorised by the licence are to be undertaken for the purposes of the Secretary, or a person authorised by the Secretary, inspecting such premises.
Medicinal cannabis permits—cultivation
(3) An application for a medicinal cannabis permit that relates to a medicinal cannabis licence that authorises the cultivation of cannabis plants must also contain the following information:
(a) the types of cannabis plants (the proposed plants) proposed to be cultivated in accordance with the permit;
(b) the range of concentration of tetrahydrocannabinol that will be contained in the proposed plants;
(c) the total area of the land to be used to cultivate the proposed plants;
(d) the maximum size of the cannabis crop proposed to be cultivated during the period of the permit;
(e) the maximum number of cannabis plants (including the number of cannabis plants that will be required to propagate cannabis plants for seeds and maintenance of strains) that, in the opinion of the applicant, it will be necessary for the applicant to have in the applicant’s possession or control at any time for the normal conduct of business;
(f) the period during which, under the permit, the plants are proposed to be cultivated for the purposes of producing cannabis or cannabis resin;
(g) the period during which, under the permit, any plants are proposed to be cultivated for the purposes of propagation.
Medicinal cannabis permits—production
(4) An application for a medicinal cannabis permit that relates to a medicinal cannabis licence that authorises the production of cannabis or cannabis resin must also contain the following information:
(a) the maximum quantity of cannabis or cannabis resin that is proposed to be produced in accordance with the permit;
(b) the maximum quantity of cannabis or cannabis resin that, in the opinion of the applicant, it will be necessary for the applicant to have in the applicant’s possession or control at any time for the normal conduct of business;
(c) the period during which cannabis or cannabis resin is proposed to be produced in accordance with the permit.
Medicinal cannabis permits—manufacture
(5) An application for a medicinal cannabis permit that relates to a medicinal cannabis licence that authorises the manufacture of a cannabis drug must also contain the following information:
(a) the cannabis drug proposed to manufactured;
(b) the proposed use of the manufactured cannabis drug;
(c) the maximum quantity of the cannabis drug that is proposed to be manufactured;
(d) the maximum quantity of the cannabis drug that, in the opinion of the applicant, having regard to prevailing market conditions, it will be necessary for the applicant to have in the applicant’s possession or control at any time for the normal conduct of business;
(e) the period during which the cannabis drug is to be manufactured;
(f) the starting materials to be used in the manufacture of the cannabis drug, the source of the starting materials and the amounts of the starting materials required to manufacture the cannabis drug.
9 Application for medicinal cannabis permit—document requirements
For the purposes of paragraph 8P(2)(c) of the Act, the following documents are prescribed as documents that must accompany an application by the holder of a medicinal cannabis licence for a medicinal cannabis permit:
(a) if the application is for the first permit relating to the location where the activities authorised by the licence will be undertaken—a copy of the risk management plan that will be used to manage risks associated with the activities authorised by the licence, including risks posed to the health and safety of people and risks posed to the environment;
(b) if the application is for the first permit relating to the location where the activities authorised by the licence will be undertaken—a copy of the standard operating procedures and policies that deal with the following matters in relation to that location:
(i) how persons entering the location will be controlled;
(ii) how unauthorised access at the location will be prevented, monitored, detected and recorded;
(iii) the physical security being used to prevent, monitor and detect the loss of cannabis plants, cannabis drugs and starting materials relating to such drugs;
(iv) the loss and theft of cannabis plants, cannabis drugs and starting materials relating to such drugs;
(v) the disposal and destruction of cannabis plants, cannabis drugs and starting materials relating to such drugs;
(vi) the supply, delivery and transportation of cannabis plants, cannabis drugs and starting materials relating to such drugs;
(vii) the arrangements with emergency services (including a police service or relevant local government authority) to deal with loss, theft, spoilage, disposal and destruction of cannabis plants, cannabis drugs and starting materials relating to such drugs;
(viii) the retention of records;
(ix) the engagement and retention of suitable staff;
(c) if the application is for a permit that relates to a medical cannabis licence that authorises the cultivation of cannabis plants or the production of cannabis or cannabis resin but does not authorise the manufacture of a cannabis drug—copies of all contracts that are in place between the applicant for the permit and a person who is authorised by a medicinal cannabis licence to do any of the following:
(i) supply cannabis plants;
(ii) produce cannabis or cannabis resin;
(iii) manufacture a cannabis drug.
10 Application fee for medicinal cannabis permit
For the purposes of subsection 8P(3) of the Act, the fee for an application for a medicinal cannabis permit that authorises:
(a) either or both the cultivation of cannabis plants, or the production of cannabis or cannabis resin under subsection 9B(1) or (2) of the Act; or
(b) the manufacture of a cannabis drug under subsection 9B(3) of the Act;
is the amount prescribed by clause 1 of Schedule 1 for the application.
11 Application for medicinal cannabis permit—particular grounds for refusal of permit
For the purposes of subparagraph 9(4)(d)(ii) of the Act, a purpose is the supply of the cannabis or cannabis resin to a person where one or more of the following apply:
(a) the person holds a licence under Part 3‑3 of the Therapeutic Goods Act 1989 for use by that person of cannabis or cannabis resin in the manufacture of a medicine (within the meaning of that Act);
(b) the person is a pharmacist in a public hospital and the supply is for the purposes of that person dispensing the cannabis or cannabis resin in accordance with that Act;
(c) the person holds an approval under subsection 19(1) of that Act to supply cannabis or cannabis resin for use solely for experimental purposes in humans;
(ca) the supply is for the purposes of that person supplying an extemporaneously‑compounded medicinal cannabis product (within the meaning of the Therapeutic Goods Regulations 1990) in accordance with the Therapeutic Goods Act 1989;
(d) the person is authorised under State or Territory legislation to obtain, possess and hold cannabis or cannabis resin for testing or research;
(e) the person holds a licence under the Customs (Prohibited Exports) Regulations 1958 to export cannabis or cannabis resin.
Division 3—Conditions of medicinal cannabis licences
17 Condition that medicinal cannabis licence holder must only use seeds, cultivars or other genetic material of cannabis plants obtained from legitimate sources
For the purposes of paragraph 10C(b) of the Act, it is a condition of a medicinal cannabis licence that the licence holder must only use seeds, cultivars or other genetic material of a cannabis plant obtained in a way that is permitted by the laws of Australia.
17A Condition that medicinal cannabis licence holder must give information relating to activities authorised by licence if requested
For the purposes of paragraph 10C(b) of the Act, it is a condition of a medicinal cannabis licence that, if the licence holder receives a request, in writing, from the Secretary for information relating to the activities authorised by the licence, the licence holder must provide the requested information within the period specified in the request (which must not be less than 14 days).
17B Condition that medicinal cannabis licence holder must retain records
For the purposes of paragraph 10C(b) of the Act, it is a condition of a medicinal cannabis licence that the licence holder must keep records that relate to the activities authorised by the licence for the period:
(a) beginning when the record came into existence; and
(b) ending 5 years after that time.
17C Condition that medicinal cannabis licence holder must notify emergency services
For the purposes of paragraph 10C(b) of the Act, it is a condition of a medicinal cannabis licence that the licence holder must ensure that:
(a) the following information is provided to the fire service and police service that have responsibility for the area in which the activity authorised by the licence is undertaken:
(i) the address of the premises at which the activity authorised by the licence is undertaken;
(ii) the name, position and contact details of a contact person from whom information may be obtained;
(iii) a general description of the activity authorised by the licence; and
(b) the information provided under paragraph (a) is kept up‑to‑date.
17D Condition that medicinal cannabis licence holder must notify Secretary of certain information
For the purposes of paragraph 10C(b) of the Act, it is a condition of a medicinal cannabis licence that the licence holder must ensure that:
(a) the following information is provided to the Secretary, in writing, before commencing an activity authorised by the licence for the first time:
(i) the name, position, phone number and email address of a contact person from whom information about the activity may be obtained;
(ii) if the licence holder is a body corporate—the name, position with the licence holder, phone number and email address of an officer or employee of the licence holder that has authority to act, or receive notices, for the licence holder; and
(b) any changes to the information provided under paragraph (a) is provided to the Secretary, in writing, within 72 hours of that change occurring.
17E Condition that medicinal cannabis licence holder must operate in accordance with risk management plan and standard operating procedures
For the purposes of paragraph 10C(b) of the Act, it is a condition of a medicinal cannabis licence that the licence holder must, when undertaking the activities authorised by the licence, operate in accordance with:
(a) the risk management plan that relates to the management of risks associated with the activities authorised by the licence; and
(b) the standard operating procedures and policies that relate to the activities authorised by the licence.
17F Condition that medicinal cannabis licence holder must maintain system of security
For the purposes of paragraph 10C(b) of the Act, it is a condition of a medicinal cannabis licence that the licence holder must maintain at all times a system of security that prevents illegal or unauthorised removal of cannabis plants or cannabis drugs from the location where the activities authorised by the licence are undertaken.
18 Condition that medicinal cannabis licence holder employ or engage suitable staff
Classes of unsuitable persons
(1) Each of the following classes of persons is prescribed for the purposes of paragraph 10F(1)(d) of the Act:
(b) persons who have a drug addiction;
(c) persons who are undischarged bankrupts under the Bankruptcy Act 1966.
Circumstances in which persons are taken not to be suitable
(2) For the purposes of subsection 10F(2) of the Act, the following circumstances are prescribed as circumstances in which a person is taken not to be suitable to carry out activities authorised by a medicinal cannabis licence at a particular time:
(a) the person has, during the period of 5 years (the exclusion period) before that time, used illicit drugs;
(b) the person has, during the exclusion period, been convicted of a drug related offence;
(c) the person has, during the exclusion period, been convicted of an offence against a law of the Commonwealth, a State or a Territory that:
(i) involves theft; and
(ii) is punishable by a maximum penalty of imprisonment for not less than 3 months.
19 Condition that medicinal cannabis licence holder be party to certain contracts
Licences authorising cultivation but not production
(1) For the purposes of subsection 10J(1) of the Act, the following matters are prescribed as matters that must be dealt with by a contract referred to in that subsection:
(a) the range of concentration of tetrahydrocannabinol that will be contained in the cannabis plants to be supplied;
(b) the number of cannabis plants to be supplied.
Licences authorising production
(2) For the purposes of paragraph 10J(2)(c) of the Act, the following matters are prescribed as matters that must be dealt with by a contract referred to in that paragraph:
(a) the range of concentration of tetrahydrocannabinol that will be contained in the cannabis plants to be used to produce the cannabis or cannabis resin to be supplied;
(b) the quantity of cannabis or cannabis resin to be supplied.
Circumstances in which contract not required—licences authorising cultivation but not production
(3) For the purposes of paragraph 10J(3)(a) of the Act, the circumstances referred to in subsection (4) of this section are prescribed as circumstances in which a contract referred to in subsection 10J(1) of the Act is not required to be in existence.
(4) For the purposes of subsection (3), the circumstances are that:
(a) a contract between:
(i) the holder (the first licence holder) of a medicinal cannabis licence of a kind referred to in paragraph 10J(1)(a) of the Act; and
(ii) the holder of another medicinal cannabis licence that authorises the production of cannabis or cannabis resin;
has ceased to be in existence and the first licence holder is taking steps to arrange a new contract with another holder of a medicinal cannabis licence that authorises the production of cannabis or cannabis resin; or
(b) the first licence holder’s licence has been suspended under the Act.
(5) Paragraph (4)(a) ceases to apply in relation to the first licence holder if the first licence holder fails to arrange a new contract within 4 months after the contract mentioned in that paragraph has ceased to be in existence.
Circumstances in which contract not required—licences authorising production
(6) For the purposes of paragraph 10J(3)(a) of the Act, the circumstances referred to in subsection (7) of this section are prescribed as circumstances in which a contract referred to in paragraph 10J(2)(c) of the Act is not required to be in existence.
(7) For the purposes of subsection (6), the circumstances are that:
(a) a contract between:
(i) the holder (the first licence holder) of a medicinal cannabis licence of a kind referred to in paragraph 10J(2)(a) of the Act; and
(ii) the holder of another medicinal cannabis licence that authorises the manufacture of a cannabis drug;
has ceased to be in existence and the first licence holder is taking steps to arrange a new contract with another holder of a medicinal cannabis licence that authorises such manufacture; or
(b) the first licence holder’s licence has been suspended under the Act.
(8) Paragraph (7)(a) ceases to apply in relation to the first licence holder if the first licence holder fails to arrange a new contract within 4 months after the contract mentioned in that paragraph has ceased to be in existence.
(9) For the purposes of paragraph 10J(3)(a) of the Act, the circumstances referred to in subsection (10) of this section are prescribed as circumstances in which a contract referred to in paragraph 10J(2)(c) of the Act is not required to be in existence.
(10) For the purposes of subsection (9), the circumstances are that the production of the cannabis or cannabis resin is for the supply of the cannabis or cannabis resin to a person who holds a licence under Part 3‑3 of the Therapeutic Goods Act 1989 for use by that person in the manufacture of a medicine (within the meaning of that Act).
20 Condition that medicinal cannabis licence holder notify the Secretary of certain matters
(1) For the purposes of paragraph 10K(1)(d) of the Act, the following matters are prescribed in relation to a medicinal cannabis licence:
(a) a security breach, a suspected security breach, an unauthorised access or a suspected unauthorised access, in relation to the location, premises or facilities covered by the licence;
(b) a theft, or a suspected theft, of cannabis plants, cannabis drugs or starting materials in relation to such drugs from the location, premises or facilities covered by the licence;
(c) a loss, or a suspected loss, of cannabis plants, cannabis drugs or starting materials in relation to such drugs at the location, premises or facilities covered by the licence;
(d) a discrepancy, or a suspected discrepancy, in the number or quantity of cannabis plants, cannabis drugs or starting materials in relation to such drugs in the possession or under the control of the licence holder;
(e) a loss, or a suspected loss, of cannabis plants, cannabis drugs or starting materials in relation to such drugs in the possession or under the control of the licence holder, other than at the location, premises or facilities covered by the licence, including during transportation of the cannabis plants, cannabis drugs or starting materials;
(f) a serious incident involving cannabis plants, cannabis drugs or starting materials in relation to such drugs in the possession or under the control of the licence holder during transportation of the cannabis plants, cannabis drugs or starting materials;
(g) an adverse finding or a recommendation, relating to security matters, made in a security audit report or other report relating to the location, premises or facilities covered by the licence;
(h) a change made, or proposed to be made, by the licence holder in relation to premises, security arrangements, conduct of activities, record‑keeping, staff or contractors, or other arrangements relating to the licence, in response to any of the following:
(i) a direction of the Secretary under section 14P of the Act;
(ii) a new condition imposed on the licence under the Act;
(iii) a variation of the licence or a medicinal cannabis permit that relates to the licence;
(iv) a finding or a recommendation notified to the licence holder and arising from the monitoring, inspection or investigation of the activities covered by the licence;
(ha) the licence holder commences to manufacture a cannabis drug under the licence;
(i) the licence holder ceases to undertake, or proposes to cease undertaking, an activity authorised by the licence;
(j) if the licence holder is a body corporate—a transaction that results in, or a proposed transaction that will result in, a change to the type, name or number of shares in the body corporate that are held by a person;
(k) if the licence holder is a body corporate—a change, or a proposed change, in any of the directors or officers of the body corporate;
(l) the licence holder has been notified that a Commonwealth, State or Territory agency has commenced to inquire into, or investigate, any actions, conduct or activities relating to the location, premises or facilities covered by the licence;
(m) if the licence holder is the holder of a medicinal cannabis licence of a kind referred to in paragraph 10J(1)(a) of the Act—a contract between:
(i) the licence holder; and
(ii) the holder of another medicinal cannabis licence that authorises the production of cannabis or cannabis resin;
is no longer in existence or is proposed to be terminated;
(n) if the licence holder is the holder of a medicinal cannabis licence of a kind referred to in paragraph 10J(2)(a) of the Act—a contract between:
(i) the licence holder; and
(ii) the holder of another medicinal cannabis licence that authorises the manufacture of a cannabis drug;
is no longer in existence or is proposed to be terminated.
(2) For the purposes of paragraph 10K(2)(a) of the Act, the licence holder must notify the Secretary within the following periods:
(a) for a matter covered by paragraph (1)(a), (b), (c), (d), (e) or (f) of this section—within 24 hours starting when the matter comes to the attention of the licence holder;
(b) for a matter covered by paragraph (1)(g) of this section—within 20 business days starting on the day the licence holder is notified of the finding or recommendation;
(c) for a matter covered by paragraph (1)(l) of this section—within 20 business days starting on the day the licence holder is notified of the inquiry or investigation.
Division 4—Variation, suspension and surrender of medicinal cannabis licences and medicinal cannabis permits
Subdivision A—Variation of medicinal cannabis licences and medicinal cannabis permits
21 Circumstances in which medicinal cannabis licences and medicinal cannabis permits must not be varied
(1) This section is made for the purposes of paragraph 10M(3)(b) of the Act.
(2) A medicinal cannabis licence must not be varied on application by the licence holder if, had the proposed variation been included as part of the application for the licence, the Secretary would have been required to refuse to grant the licence under section 8G or 8J of the Act.
(3) A medicinal cannabis permit that relates to a medicinal cannabis licence must not be varied on application by the licence holder if, had the proposed variation been included as part of the application for the permit, the Secretary would have been required to refuse to grant the permit under subsection 9(4) of the Act.
22 Application for variation of medicinal cannabis licences and medicinal cannabis permits—information requirements
For the purposes of paragraph 10N(1)(a) of the Act, an application by the holder of a medicinal cannabis licence for a variation of the medicinal cannabis licence or a medicinal cannabis permit that relates to the licence must contain information that explains the need for, and the purpose and effect of, the proposed variation.
23 Application for variation of medicinal cannabis licences and medicinal cannabis permits—document requirements
For the purposes of paragraph 10N(1)(c) of the Act, an application by the holder of a medicinal cannabis licence for a variation of the medicinal cannabis licence or a medicinal cannabis permit that relates to the licence must be accompanied by documents that support the application.
24 Application fee for variation of medicinal cannabis licences and medicinal cannabis permits
(1) This section applies for the purposes of subsection 10N(2) of the Act.
(2) To avoid doubt, an application under section 10N may apply for more than one variation of a medicinal cannabis licence or medicinal cannabis permit.
Application fee
(3) If an application for a variation of a medicinal cannabis licence or medicinal cannabis permit is covered by:
(a) a particular paragraph of the definition of licence variation type 1, licence variation type 2, licence variation type 3, permit variation type 1 or permit variation type 3; or
(b) the definition of licence variation type 4 or permit variation type 2;
the fee for the application is the amount prescribed by clause 1 of Schedule 1 for that licence variation type or permit variation type.
Application fee for multiple variations
(4) To avoid doubt, if an application for a variation of a medicinal cannabis licence or medicinal cannabis permit contains:
(a) more than one licence variation type or permit variation type; or
(b) one licence variation type or permit variation type applying to 2 or more variations; or
(c) a combination of paragraphs (a) and (b);
the fee for the application is the total of each of the amounts prescribed by clause 1 of Schedule 1 for those licence variation types or permit variation types.
Note: Example 1: The total fee for an application for 2 variations that are both a licence variation type 1 is $1,220.
Note: Example 2: The total fee for an application for 2 variations, one that is a licence variation type 1, and another that is a licence variation type 2, is $2,160.
Subdivision B—Suspension of medicinal cannabis licences and medicinal cannabis permits
25 Suspension of medicinal cannabis licences and medicinal cannabis permits
For the purposes of section 11A of the Act, this Subdivision makes provision for and in relation to the suspension of medicinal cannabis licences and medicinal cannabis permits.
26 Secretary may suspend medicinal cannabis licences and medicinal cannabis permits
(1) The Secretary may, by notice in writing given to the holder of a medicinal cannabis licence, suspend the licence, or a medicinal cannabis permit that relates to the licence, if the Secretary is satisfied on reasonable grounds that a ground exists under subsection 10P(2) of the Act to revoke the licence or permit.
(2) The suspension of a medicinal cannabis licence or a medicinal cannabis permit takes effect on the day specified in the notice under subsection (1).
(3) The day specified in the notice must be:
(a) if paragraph (b) does not apply—at least 20 business days after the day the notice is given to the holder of the medicinal cannabis licence; or
(b) if the Secretary is satisfied on reasonable grounds that there is a risk that cannabis plants, a cannabis drug or starting material in relation to such a drug may be lost, diverted or stolen if the suspension does not take effect immediately—the day the notice is given to the holder of the licence.
(5) The suspension ends on the earlier of the following:
(a) the day specified in the notice under subsection (1);
(b) if the licence or permit ceases to be in force during the period of the suspension—the day the licence or permit ceases to be in force;
(c) if the suspension is revoked—on the day the suspension is revoked.
(6) The period of the suspension must not be more than 6 months and must be set out in the notice under subsection (1).
27 Secretary may permit specified activities to occur during suspension of medicinal cannabis licences
(1) This section applies if a medicinal cannabis licence is suspended by the Secretary under subsection 26(1).
(2) The Secretary may, in the notice given under subsection 26(1) relating to the suspension, permit the licence holder during the period of the suspension to do any of the following:
(a) if the suspended licence authorised the cultivation of cannabis plants—engage in specified cultivation of cannabis plants in accordance with conditions specified in the notice;
(b) if the suspended licence authorised the production of cannabis or cannabis resin—engage in specified production of cannabis or cannabis resin in accordance with conditions specified in the notice;
(c) if the suspended licence authorised the manufacture of a cannabis drug—engage in specified manufacture of a cannabis drug in accordance with conditions specified in the notice;
(d) if the suspended licence authorised activities relating to the cultivation of cannabis plants, the production of cannabis or cannabis resin or the manufacture of a cannabis drug—engage in specified activities relating to such cultivation, production or manufacture in accordance with conditions specified in the notice.
27A Secretary may permit specified activities to occur during suspension of medicinal cannabis permits
(1) This section applies if a medicinal cannabis permit is suspended by the Secretary under subsection 26(1) and the permit relates to a medicinal cannabis licence that has not been suspended under that subsection.
(2) The Secretary may, in the notice given under subsection 26(1) relating to the suspension, permit the licence holder during the period of the suspension to do any of the following:
(a) if the suspended permit relates to a licence that authorises the cultivation of cannabis plants—engage in specified cultivation of cannabis plants authorised by the licence in accordance with the permit in accordance with conditions specified in the notice;
(b) if the suspended permit relates to a licence that authorises the production of cannabis or cannabis resin—engage in specified production of cannabis or cannabis resin authorised by the licence in accordance with the permit in accordance with conditions specified in the notice;
(c) if the suspended permit relates to a licence that authorises the manufacture of a cannabis drug—engage in specified manufacture of a cannabis drug authorised by the licence in accordance with the permit in accordance with conditions specified in the notice.
28 Secretary to notify of proposed suspension of medicinal cannabis licences and medicinal cannabis permits
(1) Before suspending under section 26 a medicinal cannabis licence, or a medicinal cannabis permit that relates to a medicinal cannabis licence, the Secretary must give written notice of the proposed suspension to the licence holder.
(2) Subsection (1) does not apply if the licence or permit is suspended in the circumstances mentioned in paragraph 26(3)(b).
(3) A notice under subsection (1) in relation to a medicinal cannabis licence or a medicinal cannabis permit must:
(a) state that the Secretary proposes to suspend the licence or permit, as the case requires, and the reasons for the proposed suspension; and
(b) invite the licence holder to make a written submission to the Secretary about the proposed suspension.
(4) A notice under subsection (1) must specify a period within which the licence holder may make a submission under paragraph (3)(b). The period must be a reasonable period in the circumstances.
(5) In deciding whether to suspend a medicinal cannabis licence or a medicinal cannabis permit, the Secretary must have regard to any submission made under paragraph (3)(b).
(6) If this section requires a notice to be given to a licence holder stating the reasons for a proposed suspension, the Secretary:
(a) must not disclose information identified as sensitive law enforcement information under subsection 14LA(1) or (2) of the Act in the notice; and
(b) if the Secretary relies upon such information in relation to the proposed suspension—must, in the case of information identified under subsection 14LA(1) of the Act, consult the giver of the information before giving the notice.
29 Effect of suspension of medicinal cannabis licences
(1) If a medicinal cannabis licence is suspended under subsection 26(1):
(a) activities authorised by the licence must not be carried out during the period of the suspension; and
(b) any medicinal cannabis permit that relates to the licence is suspended while the licence is suspended; and
(c) the licence, and any permit that relates to the licence, remains in force while the licence is suspended.
(2) Despite subsection (1), the licence holder may during the period of the suspension:
(a) if the Secretary specified activities in the notice given to the licence holder under subsection 26(1) in relation to the suspended licence—engage in the specified activities subject to any conditions specified in the notice; and
(b) if the suspended licence authorised the cultivation of cannabis plants—tend, nurture, harvest or store cannabis plants in the licence holder’s possession or control as authorised by the licence at the time of the suspension of the licence; and
(c) if the suspended licence authorised the production of cannabis or cannabis resin—store, possess and control cannabis or cannabis resin in the licence holder’s possession or control as authorised by the licence at the time of the suspension of the licence; and
(d) if the suspended licence authorised the manufacture of a cannabis drug—store, possess and control:
(i) the cannabis drugs in the licence holder’s possession or control as authorised by the licence at the time of the suspension of the licence; and
(ii) starting material relating to such drugs in the licence holder’s possession or control at the time of the suspension of the licence.
29A Effect of suspension of medicinal cannabis permits
(1) If a medicinal cannabis permit is suspended under subsection 26(1) and the permit relates to a medicinal cannabis licence that is not suspended under that subsection:
(a) activities authorised by the licence to be undertaken in accordance with the permit must not be carried out during the period that the permit is suspended; and
(b) the permit remains in force while it is suspended.
(2) Despite subsection (1), the licence holder may during the period of the suspension:
(a) if the Secretary specified activities in the notice given to the licence holder under subsection 26(1) in relation to the suspended permit—engage in the specified activities subject to any conditions specified in the notice; and
(b) if the suspended permit relates to a licence that authorises the cultivation of cannabis plants—tend, nurture, harvest or store cannabis plants in the licence holder’s possession or control as authorised by the licence at the time of the suspension of the permit; and
(c) if the suspended permit relates to a licence that authorises the production of cannabis or cannabis resin—store, possess and control cannabis or cannabis resin in the licence holder’s possession or control as authorised by the licence at the time of the suspension of the permit; and
(d) if the suspended permit relates to a licence that authorises the manufacture of a cannabis drug—store, possess and control:
(i) the cannabis drugs in the licence holder’s possession or control as authorised by the licence at the time of the suspension of the permit; and
(ii) starting material relating to such drugs in the licence holder’s possession or control at the time of the suspension of the permit.
30 Revocation of suspension of medicinal cannabis licences and medicinal cannabis permits
Revocation of suspension
(1) If a medicinal cannabis licence, or a medicinal cannabis permit that relates to the licence, is suspended, the Secretary may revoke the suspension, by written notice given to the licence holder:
(a) on the Secretary’s own initiative; or
(b) on application by the licence holder.
Applicant must provide reasons for revocation
(2) An application under paragraph (1)(b) must include reasons why the applicant considers the suspension should be revoked.
Grounds for revoking suspension
(3) The Secretary may revoke the suspension of the licence or permit if the Secretary is satisfied on reasonable grounds that:
(a) the grounds for suspending the licence or permit no longer exist; and
(b) no other grounds exist for suspending the licence or permit.
31 Matters not affected by suspension of medicinal cannabis licences and medicinal cannabis permits
(1) To avoid doubt, the following continue to have effect according to their terms during a period of suspension of a medicinal cannabis licence or a medicinal cannabis permit that relates to the licence:
(a) a condition to which the medicinal cannabis licence is subject under Division 3 of Part 2 of Chapter 2 of the Act (other than the condition under section 10J of the Act);
(b) a notice under subsection 14J(2) of the Act requiring a holder of a licence to give the Secretary further information or documents;
(c) a direction under Part 3 of Chapter 5 of the Act given to a person who is a licence holder.
(2) To avoid doubt, the suspension of a medicinal cannabis licence, or a medicinal cannabis permit that relates to the licence, does not affect the powers of an authorised inspector under Part 4 of Chapter 4 of the Act in relation to licensed premises.
32 Offence and civil penalty—breach of condition of permitted activity during suspension of licence or permit
(1) A person contravenes this subsection if:
(a) the person is the holder of a medicinal cannabis licence; and
(b) the licence, or a medicinal cannabis permit that relates to the licence, is suspended under subsection 26(1); and
(c) the Secretary permitted specified activities to occur during the period of the suspension in accordance with conditions specified in the notice given under subsection 26(1); and
(d) the person fails to comply with a condition.
Fault‑based offence
(2) A person commits an offence if the person contravenes subsection (1).
Penalty: 50 penalty units.
Civil penalty provision
(3) A person is liable to a civil penalty if the person contravenes subsection (1).
Civil penalty: 50 penalty units.
Subdivision C—Surrender of medicinal cannabis licences and medicinal cannabis permits
33 Surrender of medicinal cannabis licences and medicinal cannabis permits
For the purposes of section 11A of the Act, this Subdivision makes provision for and in relation to the surrender of medicinal cannabis licences and medicinal cannabis permits.
34 Licence holder may surrender medicinal cannabis licences and medicinal cannabis permits
(1) The holder of a medicinal cannabis licence or medicinal cannabis permit may surrender the licence or permit by giving the Secretary a written notice of surrender in accordance with this section.
(2) The notice must be signed by the holder and must contain the following information:
(a) details of the licence or permit to be surrendered;
(b) the day on which the surrender is proposed to take effect;
(c) if the activities authorised by the licence or permit have not ceased—the day the activities are expected to cease;
(d) if the activities authorised by the licence or permit have ceased—the day the activities ceased;
(e) details of the manner in which any cannabis plants or cannabis drug (the authorised product), in the holder’s possession or control as authorised by the licence or permit, have been, or will be, dealt with by the holder, including the following details:
(i) if the authorised product has been supplied, or will be supplied, to another holder of a medicinal cannabis licence—the name of that other holder, when the authorised product was, or will be, supplied to that other holder, and the amount of authorised product supplied, or that will be supplied, to that other holder;
(ii) if the authorised product has been supplied, or will be supplied, to an end user of the authorised product—the name of that end user, when the authorised product was, or will be, supplied to that end user, and the amount of authorised product supplied, or to be supplied, to that end user;
(iii) if the authorised product has been, or will be, disposed of or destroyed—the day on which, and the location at which, the disposal or destruction took place, or will take place, and details of all persons who carried out, or will carry out, the disposal or destruction;
(f) details of the manner in which any equipment or material used for the cultivation, production or manufacture of the authorised product has been, or will be, disposed of by the holder;
(g) the address at which the holder’s records, books, electronic data and other documents relating to the licence or permit will be kept after the licence or permit is surrendered;
(h) the name, address, telephone number and email address of a person who the Secretary may contact for further information after the licence or permit has been surrendered.
(3) If the holder notifies the Secretary in accordance with this section, the licence or permit ceases to be in force on the later of the following:
(a) the day specified in the notice as the day on which the surrender is to take effect;
(b) if, on the day the person gives the Secretary the notice of surrender, the activities authorised by the licence or permit have ceased and the authorised product has been disposed of or destroyed—20 business days after the day the holder gives the Secretary the notice of surrender;
(c) if, on the day the person gives the Secretary the notice of surrender, the activities authorised by the licence or permit have not ceased and the authorised product has not been disposed of or destroyed—20 business days after the day the holder gives the Secretary a further notice in writing stating that the activities authorised by the licence or permit have ceased and the authorised product has been disposed of or destroyed.
(4) However, if, after the holder notifies the Secretary in accordance with this section, the Secretary gives the holder written notice that the licence or permit is to cease to be in force on a specified day that:
(a) is earlier or later than the day worked out under subsection (3); and
(b) is agreed by the holder and the Secretary;
the licence or permit ceases to be in force on the specified day.
Part 3—Licensing the manufacturing of narcotic drugs
Division 1—Manufacture licences and permits
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.
Note: A person may commit an offence if the person provides false or misleading information (see section 137.1 of the Criminal Code).
36 Application for manufacture licence—document requirements
(1) For the purposes of paragraph 11G(2)(c) of the Act, the documents specified in this section are prescribed as the documents that must accompany an application by a person (the applicant) for a manufacture licence.
(2) The following documents must accompany the application:
(b) documents that provide evidence that the applicant has a sound and stable financial background and is not in financial circumstances that may significantly limit the applicant’s capacity to comply with the applicant’s obligations under a licence;
Note: Such documents could include, for example, bank statements or audited financial statements.
(c) a site plan showing how land at the location where the activities will be undertaken will be utilised;
(d) a detailed floor plan of the premises and facilities at the location where the activities will be undertaken;
(f) a risk management plan to manage risks associated with the activities, including risks posed to the health and safety of people, or to the environment.
Note: A person may commit an offence if the person provides false or misleading documents (see section 137.2 of the Criminal Code).
36A Application for manufacture licence—general grounds for refusal of licence
For the purposes of paragraph 11J(1)(f) of the Act, a circumstance in which a licence must not be granted is that the applicant for the licence is reasonably likely:
(a) not to be a resident of Australia; and
(b) not to carry on business in Australia;
at a time when the licence is proposed to be in force.
37 Matters to be specified in a manufacture licence—persons prescribed
For the purposes of paragraph 11N(e) of the Act, the following persons are prescribed as persons who are authorised by a manufacture licence to engage in the activities authorised by the licence:
(a) the licence holder;
(b) the person who holds a managerial or supervisory position that has direct control over the activities authorised by the licence;
(c) the person responsible for controlling on a daily basis the activities authorised by the licence.
38 Application for manufacture permit—information requirements
(1) For the purposes of paragraph 12(2)(a) of the Act, the information specified in this section is prescribed in relation to an application by the holder of a manufacture licence (the applicant) for a manufacture permit.
(2) The application must contain the following information:
(a) the name of the applicant;
(b) the licence number of the manufacture licence held by the applicant;
(c) details of the narcotic drug proposed to be manufactured;
(d) details of the proposed end use of the manufactured drugs;
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.
(e) details of the starting materials to be used, the source of the starting materials and the amounts of the starting materials required, to manufacture the narcotic drug;
(f) details of the maximum quantities of the narcotic drug that is to be manufactured;
(g) details of the maximum quantities of the narcotic drug that, in the opinion of the applicant, having regard to prevailing market conditions, it will be necessary for the applicant to have in the applicant’s possession or control at any time for the normal conduct of business;
(h) the period during which the narcotic drug is to be manufactured;
(i) the period for which the permit is proposed to be in force.
Division 2—Conditions of manufacture licences
39 Condition that manufacture licence holder employ or engage suitable staff
Classes of unsuitable persons
(1) Each of the following classes of persons is prescribed for the purposes of paragraph 12H(1)(d) of the Act:
(b) persons who have a drug addiction;
(c) persons who are undischarged bankrupts under the Bankruptcy Act 1966.
Circumstances in which persons are taken not to be suitable
(2) For the purposes of subsection 12H(2) of the Act, the following circumstances are prescribed as circumstances in which a person is taken not to be suitable to carry out activities authorised by a manufacture licence at a particular time:
(a) the person has, during the period of 5 years (the exclusion period) before that time, used illicit drugs;
(b) the person has, during the exclusion period, been convicted of a drug related offence;
(c) the person has, during the exclusion period, been convicted of an offence against a law of the Commonwealth, a State or a Territory that:
(i) involves theft; and
(ii) is punishable by a maximum penalty of imprisonment for not less than 3 months.
40 Condition that manufacture licence holder notify the Secretary of certain matters
(1) For the purposes of paragraph 12N(1)(d) of the Act, the following matters are prescribed in relation to a manufacture licence:
(a) a security breach, a suspected security breach, an unauthorised access or a suspected unauthorised access, in relation to the location, premises or facilities covered by the licence;
(b) a theft, or a suspected theft, of narcotic drugs or starting materials in relation to such drugs from the location, premises or facilities covered by the licence;
(c) a loss, or a suspected loss, of narcotic drugs or starting materials in relation to such drugs at the location, premises or facilities covered by the licence;
(d) a discrepancy, or a suspected discrepancy, in the quantity of narcotic drugs or starting materials in relation to such drugs in the possession or under the control of the licence holder;
(e) a loss, or a suspected loss, of narcotic drugs or starting materials in relation to such drugs in the possession or under the control of the licence holder, other than at the location, premises or facilities covered by the licence, including during transportation of the narcotic drugs or starting materials;
(f) a serious incident involving a narcotic drug or starting material in relation to such a drug in the possession or under the control of the licence holder during transportation of the narcotic drugs or starting materials;
(g) an adverse finding or a recommendation, relating to security matters, made in a security audit report or other report relating to the location, premises or facilities covered by the licence;
(h) a change made, or proposed to be made, by the licence holder in relation to premises, security arrangements, conduct of activities, record‑keeping, staff or contractors, or other arrangements relating to the licence, in response to any of the following:
(i) a direction of the Secretary under section 14P of the Act;
(ii) a new condition imposed on the manufacture licence under the Act;
(iii) a variation of the licence or of a manufacture permit that relates to the licence;
(iv) a finding or a recommendation notified to the licence holder and arising from the monitoring, inspection or investigation of the activities covered by the licence;
(i) the licence holder commences to manufacture a narcotic drug under the licence;
(j) the licence holder ceases to undertake, or proposes to cease undertaking, the manufacture of a narcotic drug or any other activities authorised by the licence;
(k) if the licence holder is a body corporate—a transaction that results in, or a proposed transaction that will result in, a change to the type, name or number of shares in the body corporate that are held by a person;
(l) if the licence holder is a body corporate—a change, or a proposed change, in any of the directors or officers of the body corporate;
(m) the licence holder has been notified that a Commonwealth, State or Territory agency has commenced to inquire into, or investigate, any actions, conduct or activities relating to the location, premises or facilities covered by the licence.
(2) For the purposes of paragraph 12N(2)(a) of the Act, the period for a matter covered by paragraph (1)(a), (b), (c), (d), (e) or (f) of this section is 72 hours starting when the matter comes to the attention of the licence holder.
Division 3—Variation, suspension and surrender of manufacture licences and manufacture permits
Subdivision A—Variation of manufacture licences and permits
41 Circumstances in which a manufacture licence or manufacture permit must not be varied
(1) This section is made for the purposes of paragraph 13(3)(b) of the Act.
(2) A manufacture licence must not be varied on application by the licence holder if, had the proposed variation been included as part of the application for the licence, the Secretary would have been required to refuse to grant the licence under section 11J of the Act.
(3) A manufacture permit that relates to a manufacture licence must not be varied on application by the licence holder if, had the proposed variation been included as part of the application for the permit, the Secretary would have been required to refuse to grant the permit under subsection 12A(4) of the Act.
42 Application for variation of manufacture licence or permit—information requirements
For the purposes of paragraph 13A(1)(a) of the Act, an application by the holder of a manufacture licence for a variation of the manufacture licence or a manufacture permit that relates to the licence must contain information that explains the need for, and the purpose and effect of, the proposed variation.
43 Application for variation of manufacture licence or permit—document requirements
For the purposes of paragraph 13A(1)(c) of the Act, an application by the holder of a manufacture licence for a variation of the manufacture licence or a manufacture permit that relates to the licence must be accompanied by documents that support the application.
Subdivision B—Suspension of manufacture licences and permits
44 Suspension of manufacture licences and permits
For the purposes of section 13D of the Act, this Subdivision makes provision for and in relation to the suspension of manufacture licences and manufacture permits.
45 Secretary may suspend manufacture licences and permits
(1) The Secretary may, by notice in writing given to the holder of a manufacture licence, suspend the licence, or a manufacture permit that relates to the licence, if the Secretary is satisfied on reasonable grounds that a ground exists under subsection 13B(2) of the Act to revoke the manufacture licence or manufacture permit.
(2) The suspension of a manufacture licence or a manufacture permit takes effect on the day specified in the notice under subsection (1).
(3) The day specified in the notice must be:
(a) if paragraph (b) does not apply—at least 20 business days after the day the notice is given to the holder of the manufacture licence; or
(b) if the Secretary is satisfied on reasonable grounds that there is a risk that a narcotic drug or starting material in relation to such a drug may be lost, diverted or stolen if the suspension does not take effect immediately—the day the notice is given to the holder of the licence.
(5) The suspension ends on the earlier of the following:
(a) the day specified in the notice under subsection (1);
(b) if the licence or permit ceases to be in force during the period of the suspension—the day the licence or permit ceases to be in force;
(c) if the suspension is revoked—on the day the suspension is revoked.
(6) The period of the suspension must not be more than 6 months and must be set out in the notice under subsection (1).
46 Secretary to notify of proposed suspension of manufacture licence or permit
(1) Before suspending under section 45 a manufacture licence, or a manufacture permit that relates to the licence, the Secretary must give written notice of the proposed suspension to the licence holder.
(2) Subsection (1) does not apply if the licence or permit is suspended in the circumstances mentioned in paragraph 45(3)(b).
(3) A notice under subsection (1) in relation to a manufacture licence or a manufacture permit must:
(a) state that the Secretary proposes to suspend the licence or permit, as the case requires, and the reasons for the proposed suspension; and
(b) invite the licence holder to make a written submission to the Secretary about the proposed suspension.
(4) A notice under subsection (1) must specify a period within which the licence holder may make a submission under paragraph (3)(b). The period must be a reasonable period in the circumstances.
(5) In deciding whether to suspend a manufacture licence or a manufacture permit, the Secretary must have regard to any submission made under paragraph (3)(b).
(6) If this section requires a notice to be given to a manufacture licence holder stating the reasons for a proposed suspension, the Secretary:
(a) must not disclose information identified as sensitive law enforcement information under subsection 14LA(1) or (2) of the Act in the notice; and
(b) if the Secretary relies upon such information in relation to the proposed suspension—must, in the case of information identified under subsection 14LA(1) of the Act, consult the giver of the information before giving the notice.
47 Effect of suspension of manufacture licences
(1) If a manufacture licence is suspended under subsection 45(1):
(a) activities authorised by the licence must not be carried out during the period of the suspension; and
(b) any manufacture permit that relates to the licence is suspended while the licence is suspended; and
(c) the licence, and any permit that relates to the licence, remain in force while the licence is suspended.
(2) Despite subsection (1), the licence holder is authorised during the period of the suspension to store, possess and control any narcotic drugs in the licence holder’s possession or control as authorised by the licence at the time of the suspension.
47A Effect of suspension of manufacture permit
(1) If a manufacture permit is suspended under subsection 45(1) and the permit relates to a manufacture licence that is not suspended under that subsection:
(a) activities authorised by the licence to be undertaken in accordance with the permit must not be carried out during the period that the permit is suspended; and
(b) the permit remains in force while it is suspended.
(2) Despite subsection (1), the licence holder is authorised during the period of the suspension to store, possess and control any narcotic drugs in the licence holder’s possession or control as authorised by the permit at the time of the suspension.
48 Revocation of suspension of manufacture licence or permit
Revocation of suspension
(1) If a manufacture licence, or a manufacture permit that relates to the licence, is suspended, the Secretary may revoke the suspension, by written notice given to the licence holder:
(a) on the Secretary’s own initiative; or
(b) on application by the licence holder.
Applicant must provide reasons for revocation
(2) An application under paragraph (1)(b) must include reasons why the applicant considers the suspension should be revoked.
Grounds for revoking suspension
(3) The Secretary may revoke the suspension of the licence or permit if the Secretary is satisfied on reasonable grounds that:
(a) the grounds for suspending the licence or permit no longer exist; and
(b) no other grounds exist for suspending the licence or permit.
49 Matters not affected by suspension of manufacture licence or permit
(1) To avoid doubt, the following continue to have effect according to their terms during a period of suspension of a manufacture licence or a manufacture permit that relates to the licence:
(a) a condition to which the manufacture licence is subject under Division 2 of Part 2 of Chapter 3 of the Act;
(b) a notice under subsection 14J(2) of the Act requiring a holder of a licence to give the Secretary further information or documents;
(c) a direction under Part 3 of Chapter 5 of the Act given to a person who is a licence holder.
(2) To avoid doubt, the suspension of a manufacture licence, or a manufacture permit that relates to the licence, does not affect the powers of an authorised inspector under Part 4 of Chapter 4 of the Act in relation to licensed premises.
Subdivision C—Surrender of manufacture licences and permits
50 Surrender of manufacture licences and permits
For the purposes of section 13D of the Act, this Subdivision makes provision for and in relation to the surrender of manufacture licences and manufacture permits.
51 Licence holder may surrender manufacture licence or permit
(1) The holder of a manufacture licence or manufacture permit may surrender the licence or permit by giving the Secretary a written notice of surrender in accordance with this section.
(2) The notice must be signed by the holder and must contain the following information:
(a) details of the manufacture licence or manufacture permit being surrendered;
(b) the day on which the surrender is proposed to take effect;
(c) if the activities authorised by the licence or permit have not ceased—the day the activities are expected to cease;
(d) if the activities authorised by the licence or permit have ceased—the day the activities ceased;
(e) details of the manner in which a narcotic drug (the authorised product), in the holder’s possession or control as authorised by the licence or permit, have been, or will be, dealt with by the holder, including the following details:
(i) if the authorised product has been supplied, or will be supplied, to another holder of a manufacture licence—the name of that other holder, when the authorised product was, or will be, supplied to that other holder, and the amount of authorised product supplied, or that will be supplied, to that other holder;
(ii) if the authorised product has been supplied, or will be supplied, to an end user of the authorised product—the name of that end user, when the authorised product was, or will be, supplied to that end user, and the amount of authorised product supplied, or to be supplied, to that end user;
(iii) if the authorised product has been, or will be, disposed of or destroyed—the day on which, and the location at which, the disposal or destruction took place, or will take place, and details of all persons who carried out, or will carry out, the disposal or destruction;
(f) details of the manner in which any equipment or material used to manufacture the authorised product has been, or will be, disposed of by the holder;
(g) the address and location at which the holder’s records, books, electronic data and other documents relating to the licence or permit will be kept after the licence or permit is surrendered;
(h) the name, address, telephone number and email address of a person who the Secretary may contact for further information after the licence or permit has been surrendered.
(3) If the holder notifies the Secretary in accordance with this section, the licence or permit ceases to be in force on the later of the following:
(a) the day specified in the notice as the day on which the surrender is to take effect;
(b) if, on the day the person gives the Secretary the notice of surrender, the activities authorised by the licence or permit have ceased and the authorised product has been disposed of or destroyed—20 business days after the day the holder gives the Secretary the notice of surrender;
(c) if, on the day the person gives the Secretary the notice of surrender, the activities authorised by the licence or permit have not ceased and the authorised product has not been disposed of or destroyed—20 business days after the day the holder gives the Secretary a further notice in writing stating that the activities authorised by the licence or permit have ceased and the authorised product has been disposed of or destroyed.
(4) However, if, after the holder notifies the Secretary in accordance with this section, the Secretary gives the holder written notice that the licence or permit is to cease to be in force on a specified day that:
(a) is earlier or later than the day worked out under subsection (3); and
(b) is agreed by the holder and the Secretary;
the licence or permit ceases to be in force on the specified day.
Part 4—Review of decisions
52 Reviewable decisions
For the purposes of subsection 15E(2) of the Act, each of the following decisions of the Secretary is a reviewable decision:
(a) a decision under section 26 to suspend a medicinal cannabis licence or a medicinal cannabis permit that relates to the licence;
(b) a decision under subsection 27(2) to refuse to permit specified activities during a period of suspension of a medicinal cannabis licence;
(c) a decision under subsection 27A(2) to refuse to permit specified activities during a period of suspension of a medicinal cannabis permit;
(d) a decision under section 30 to refuse to revoke a suspension of a medicinal cannabis licence or a medicinal cannabis permit that relates to the licence;
(e) a decision under section 45 to suspend a manufacture licence or a manufacture permit that relates to the licence;
(f) a decision under section 48 to refuse to revoke a suspension of a manufacture licence or a manufacture permit that relates to the licence;
(g) a decision under section 53;
(h) a decision under paragraph 54A(1)(c) about whether the activities an applicant proposes to undertake under a medicinal cannabis licence will be undertaken for, or primarily for, medicinal or scientific research that is for a non‑commercial purpose.
Part 5—Other matters
Division 1—Inspection fees
54 Inspection fees
(1) If an inspection of premises is conducted in relation to an application for:
(a) a licence; or
(b) a permit that relates to a licence; or
(c) a variation of a licence; or
(d) a variation of a permit that relates to a licence;
then, for the purposes of paragraph 28(1)(c) of the Act, a fee (the inspection fee) of $9,560 is payable for the inspection.
(2) The inspection fee:
(a) is payable to the Secretary on behalf of the Commonwealth by the applicant; and
(b) must be paid on or before the last day for payment of the fee shown on an invoice issued to the applicant by the Secretary; and
(c) is recoverable as a debt due to the Commonwealth.
Division 1A—Charges
54A Classes of medicinal cannabis licences for the purposes of charge
Non‑commercial medicinal cannabis licence
(1) For the purposes of paragraph 28(1)(e) of the Act, a medicinal cannabis licence is a non‑commercial medicinal cannabis licence if:
(a) if the licence was in effect on the commencement of this section because the licence was preserved under item 2 of Schedule 2 to the Narcotic Drugs Amendment (Medicinal Cannabis) Act 2021—the Secretary had, in relation to the licence, given a notice under subsection 54A(2), 54AA(3) or 54AB(3) of this instrument, as in force immediately before the commencement of this section; or
(b) if the licence was in effect on the commencement of this section because the licence was converted from multiple licences (the original licences) into a single licence under item 3 of Schedule 2 to the Narcotic Drugs Amendment (Medicinal Cannabis) Act 2021—the Secretary had, in relation to one of those original licences, given a notice under subsection 54A(2), 54AA(3) or 54AB(3) of this instrument, as in force immediately before the commencement of this section; or
(c) when granting the licence the Secretary notifies the applicant for the licence in writing that the Secretary is reasonably satisfied that the activities the applicant proposes to undertake under the licence will be undertaken:
(i) for medical or scientific research that is for a non‑commercial purpose; or
(ii) primarily for medical or scientific research that is for a non‑commercial purpose.
(2) In making a decision under paragraph (1)(c) about the activities that the applicant proposes to undertake, the Secretary must have regard to the matters mentioned in paragraph 5(2)(j).
(3) Subsection (2) does not limit the matters to which the Secretary may have regard in making a decision under paragraph (1)(c).
Commercial medicinal cannabis licence
(4) For the purposes of paragraph 28(1)(e) of the Act, a medicinal cannabis licence is a commercial medicinal cannabis licence if a notice referred to in paragraph (1)(a), (b) or (c) has not been given in relation to the licence.
54B Payment of charge
(1) This section is for the purposes of subparagraph 28(1)(e)(i) of the Act.
(2) Charge payable on a licence, or a matter that relates to a licence, is payable to the Secretary on behalf of the Commonwealth.
(3) An amount of charge payable on a licence, or a matter that relates to a licence, is due and payable on the day specified in an invoice for the amount given to the holder of the licence by the Secretary.
54C Recovery of charge
For the purposes of paragraph 28(1)(e) of the Act, an amount of charge that is due and payable:
(a) is a debt due to the Commonwealth; and
(b) may be recovered by the Secretary on behalf of the Commonwealth by action in a court of competent jurisdiction.
Division 2—Other matters
55 Secretary to notify States and Territories of certain matters
For the purposes of subsection 25B(2) of the Act, the following matters are prescribed in relation to a licence or permit that relates to premises situated wholly or partly in a State or Territory:
(a) the granting of the licence or permit;
(b) the following details of the licence or permit:
(i) the name and contact details of the holder of the licence or permit;
(ii) details of the location and premises covered by the licence or permit;
(iii) the conditions of the licence (other than conditions that are specified in the Act or prescribed by these regulations);
(iv) the period during which the licence or permit is in force;
(c) a variation of the licence or permit;
(d) the suspension or revocation of the licence or permit;
(e) a proposal to suspend or revoke the licence or permit (including details of the day on which the licence or suspension is proposed to be suspended or revoked);
(f) the surrender of the licence or permit.
56 Modification of operation of Chapters 2 and 3 of the Act
For the purposes of paragraph 27(4)(g) of the Act:
(a) paragraph 8G(1)(a) of the Act does not apply if the applicant for the medicinal cannabis licence is an agency of the Commonwealth, a State or a Territory; and
(c) paragraph 10K(1)(a) of the Act does not apply if the holder of the medicinal cannabis licence is an agency of the Commonwealth, a State or a Territory; and
(d) paragraphs 10P(1)(b) and (c) of the Act do not apply if the holder of the medicinal cannabis licence is an agency of the Commonwealth, a State or a Territory; and
(e) paragraph 11J(1)(a) of the Act does not apply if the applicant for the manufacture licence is an agency of the Commonwealth, a State or a Territory; and
(f) paragraph 12N(1)(a) of the Act does not apply if the holder of the manufacture licence is an agency of the Commonwealth, a State or a Territory; and
(g) paragraphs 13B(1)(b) and (c) of the Act do not apply if the holder of the manufacture licence is an agency of the Commonwealth, a State or a Territory.
Part 6—Application, saving and transitional provisions
57 Application provisions relating to the Narcotic Drugs Amendment (Cannabis) Regulations 2018
(1) The amendments of section 5 made by the Narcotic Drugs Amendment (Cannabis) Regulations 2018 apply in relation to applications made under section 8E of the Act on or after the commencement of this section.
(2) Sections 7A and 7B, as inserted by the Narcotic Drugs Amendment (Cannabis) Regulations 2018, apply in relation to applications made under section 8E of the Act on or after the commencement of this section.
(3) The amendments of section 11 made by the Narcotic Drugs Amendment (Cannabis) Regulations 2018 apply in relation to applications made under section 9D of the Act on or after the commencement of this section.
(4) Section 13A, as inserted by the Narcotic Drugs Amendment (Cannabis) Regulations 2018, applies in relation to applications made under section 9D of the Act on or after the commencement of this section.
(5) The amendments of sections 14 and 15 made by the Narcotic Drugs Amendment (Cannabis) Regulations 2018 apply in relation to applications made under section 9N of the Act on or after the commencement of this section.
(6) The amendment of section 19 made by the Narcotic Drugs Amendment (Cannabis) Regulations 2018 applies in relation to medicinal cannabis licences granted under the Act on or after the commencement of this section.
(7) Subsection 20(2), as added by the Narcotic Drugs Amendment (Cannabis) Regulations 2018, applies in relation to matters arising on or after the commencement of this section, whether the cannabis licences were granted under the Act before, on or after the commencement of this section.
(8) Subsection 28(6), as added by the Narcotic Drugs Amendment (Cannabis) Regulations 2018, applies in relation to notices given under subsection 28(1) on or after the commencement of this section.
(9) The amendments of sections 35 and 36 made by the Narcotic Drugs Amendment (Cannabis) Regulations 2018 apply in relation to applications made under section 11G of the Act on or after the commencement of this section.
(10) Section 36A, as inserted by the Narcotic Drugs Amendment (Cannabis) Regulations 2018, applies in relation to applications made under section 11G of the Act on or after the commencement of this section.
(11) Section 37, as substituted by the Narcotic Drugs Amendment (Cannabis) Regulations 2018, applies in relation to applications made under section 11G of the Act on or after the commencement of this section.
(12) The amendments of section 38 made by the Narcotic Drugs Amendment (Cannabis) Regulations 2018 apply in relation to applications made under section 12 of the Act on or after the commencement of this section.
(13) Subsection 40(2), as added by the Narcotic Drugs Amendment (Cannabis) Regulations 2018, applies in relation to matters arising on or after the commencement of this section, whether the manufacture licences were granted under the Act before, on or after the commencement of this section.
(14) Subsection 46(6), as added by the Narcotic Drugs Amendment (Cannabis) Regulations 2018, applies in relation to notices given under subsection 46(1) on or after the commencement of this section.
(15) Section 56, as added by the Narcotic Drugs Amendment (Cannabis) Regulations 2018, applies in relation to:
(a) in the case of paragraphs 56(a), (b) and (e)—applications made on or after the commencement of this section; and
(b) in the case of paragraphs 56(c), (d), (f) and (g)—licences granted on or after the commencement of this section.
(16) The amendments of clause 1 of Schedule 1 made by the Narcotic Drugs Amendment (Cannabis) Regulations 2018 apply in relation to applications made on or after the commencement of this section.
58 Application provisions relating to the Narcotic Drugs Amendment (Review Recommendations) Regulations 2019
Amendments etc. affecting applications for medicinal cannabis licences
(1) The amendments of sections 5 and 7B, and the repeal and substitution of section 7A, by the Narcotic Drugs Amendment (Review Recommendations) Regulations 2019 apply in relation to applications for medicinal cannabis licences made on or after 1 January 2020.
Amendments affecting applications for medicinal cannabis permits
(2) The amendments of sections 8 and 9 by the Narcotic Drugs Amendment (Review Recommendations) Regulations 2019 apply in relation to applications for medicinal cannabis permits made on or after 1 January 2020.
Amendments etc. affecting applications for cannabis research licences
(3) The amendments of section 11, and the repeal and substitution of section 13A, by the Narcotic Drugs Amendment (Review Recommendations) Regulations 2019 apply in relation to applications for cannabis research licences made on or after 1 January 2020.
Amendments etc. affecting applications for cannabis research permits
(4) The amendments of sections 14 and 17, and the repeal of section 15, by the Narcotic Drugs Amendment (Review Recommendations) Regulations 2019 apply in relation to applications for cannabis research permits made on or after 1 January 2020.
Amendments affecting conditions on medicinal cannabis licences
(5) The amendments of section 19 by the Narcotic Drugs Amendment (Review Recommendations) Regulations 2019 apply in relation to medicinal cannabis licences granted on or after 1 January 2020.
Amendments affecting surrender of cannabis licences and permits
(6) The amendments of section 34 by the Narcotic Drugs Amendment (Review Recommendations) Regulations 2019 apply in relation to notices, of surrender of cannabis licences or cannabis permits, given on or after 1 January 2020.
Amendments etc. affecting applications for manufacture licences
(7) The amendments of sections 35 and 37, and the repeal and substitution of section 36A, by the Narcotic Drugs Amendment (Review Recommendations) Regulations 2019 apply in relation to applications for manufacture licences made on or after 1 January 2020.
Amendments affecting surrender of manufacture licences and permits
(8) The amendments of section 51 by the Narcotic Drugs Amendment (Review Recommendations) Regulations 2019 apply in relation to notices, of surrender of manufacture licences or manufacture permits, given on or after 1 January 2020.
59 Application provisions relating to the Narcotic Drugs Amendment (Fees) Regulations 2020
(1) The repeal of section 53, and the amendment of Schedule 1, by the Narcotic Drugs Amendment (Fees) Regulations 2020 apply in relation to applications made on or after 15 July 2020.
(2) The amendment of subsection 54(1) made by the Narcotic Drugs Amendment (Fees) Regulations 2020 applies to inspections started on or after 15 July 2020.
(3) The repeal and substitution of section 54B by the Narcotic Drugs Amendment (Fees) Regulations 2020 applies to charge on a licence in force on or after 15 July 2020.
(4) The amendment of section 54C by the Narcotic Drugs Amendment (Fees) Regulations 2020 applies to charge on a licence in force on or after 15 July 2020.
60 Application provisions relating to the Narcotic Drugs Amendment (Cannabis‑Related Manufacture Licences and Permits) Regulations 2020
(1) The amendment of section 35 by the Narcotic Drugs Amendment (Cannabis‑Related Manufacture Licences and Permits) Regulations 2020 applies in relation to applications made on or after 1 November 2020.
(2) Sections 36AA, 38A and 43A apply in relation to applications made on or after 1 November 2020.
(3) The amendments of Schedule 1 by the Narcotic Drugs Amendment (Cannabis‑Related Manufacture Licences and Permits) Regulations 2020 apply in relation to applications made on or after 1 November 2020.
61 Application provisions relating to the Narcotic Drugs Amendment (Fees) Regulations 2021
(1) The amendment of subsection 54(1) by the Narcotic Drugs Amendment (Fees) Regulations 2021 applies to inspections started on or after 1 July 2021.
(2) The amendments of clause 1 of Schedule 1 by the Narcotic Drugs Amendment (Fees) Regulations 2021 apply in relation to applications made on or after 1 July 2021.
62 Application provisions relating to the Narcotic Drugs Amendment (Medicinal Cannabis) Regulations 2021
(1) Sections 17, 17A, 17B, 17C, 17D, 17E and 17F, as inserted by Schedule 1 to the Narcotic Drugs Amendment (Medicinal Cannabis) Regulations 2021, apply in relation to a medicinal cannabis licence held at the commencement of this section or granted on or after the commencement of this section.
(2) The amendments of sections 20 and 40 made by Schedule 1 to the Narcotic Drugs Amendment (Medicinal Cannabis) Regulations 2021 apply in relation to a matter that comes to the attention of a licence holder on or after the commencement of this section, whether in relation to a licence held at the commencement of this section or granted on or after the commencement of this section.
(3) If:
(a) before the commencement of this section the Secretary had, under subsection 26(1) or 45(1), given to the holder of a licence notice in writing of the suspension of the licence or a permit that relates to the licence (the suspension notice); and
(b) immediately before the commencement of this section, either of the following apply:
(i) the suspension had not come into effect because the day specified in the notice of suspension had not occurred;
(ii) the period of the suspension had started but not ended; and
(c) the licence or permit is preserved or converted under item 2 or 3 of Schedule 2 to the Narcotic Drugs Amendment (Medicinal Cannabis) Act 2021;
then, after the commencement of this section:
(d) the preserved or converted licence or permit is taken to be suspended under Subdivision B of Division 4 of Part 2 of this instrument as amended by Schedule 1 to the Narcotic Drugs Amendment (Medicinal Cannabis) Regulations 2021; and
(e) the suspension may be dealt with under that Subdivision as so amended; and
(f) if the suspension is still to come into effect because the day specified in the notice of suspension has not occurred—the suspension takes effect in accordance with the suspension notice; and
(g) if the suspension notice permits specified activities to occur during the period of the suspension—the permitted activities can occur during the period of the suspension in accordance with the conditions specified in the suspension notice.
(4) If:
(a) a decision was made under this instrument before the commencement of this section; and
(b) the decision is a decision of the kind referred to in paragraph 52(b), (c), (h), (i) or (j) as in force immediately before the commencement of this section; and
(c) immediately before the commencement of this section, the period referred to in paragraph 15G(2)(c) of the Act during which a person may apply for review of the decision has not ended;
despite the amendments of section 52 made by Schedule 1 to the Narcotic Drugs Amendment (Medicinal Cannabis) Regulations 2021, Part 4 of Chapter 5 of the Act continues to have effect in relation to the decision as if the amendments had not been made.
(5) If:
(a) a decision (the review decision) was made under section 15H of the Act before the commencement of this section; and
(b) the review decision relates to a decision of the kind referred to in paragraph (4)(b) of this section; and
(c) immediately before the commencement of this section, both of the following apply:
(i) an application for review of the review decision by the Administrative Appeals Tribunal had not been made;
(ii) the time for a person to make such an application has not ended (including any extensions of that time under section 29 of the Administrative Appeals Tribunal Act 1975);
despite the amendments of section 52 made by Schedule 1 to the Narcotic Drugs Amendment (Medicinal Cannabis) Regulations 2021, sections 15L, 15M and 15N of the Act continue, after the commencement of this section, to have effect in relation to the review decision as if the amendments had not been made.
(6) The amendments of section 56, made by Schedule 1 to the Narcotic Drugs Amendment (Medicinal Cannabis) Regulations 2021, apply in relation to:
(a) in the case of paragraphs 56(a) and (e)—applications made on or after the commencement of this section; and
(b) in the case of paragraphs 56(c), (d), (f) and (g)—licences granted on or after the commencement of this section.
(7) Clause 1 of Schedule 1, as amended by Schedule 1 to the Narcotic Drugs Amendment (Medicinal Cannabis) Regulations 2021, applies in relation to applications made on or after the commencement of this section.
63 Application of amendments of the Narcotic Drugs Amendment (Fees) Regulations 2023
(1) The amendments of sections 4, 10 and 24, and clause 1 of Schedule 1, made by the Narcotic Drugs Amendment (Fees) Regulations 2023, apply to applications made on or after 1 August 2023.
(2) The amendment of subsection 54(1) made by the Narcotic Drugs Amendment (Fees) Regulations 2023 applies in relation to inspections commenced on or after 1 August 2023.
(3) The amendments of subsections 54B(2) and (3) made by the Narcotic Drugs Amendment (Fees) Regulations 2023 apply to inspections commenced on or after 1 August 2023.
64 Application provisions relating to the Narcotic Drugs Amendment (Fees) Regulations 2024
(1) The amendment of subsection 54(1) made by the Narcotic Drugs Amendment (Fees) Regulations 2024 applies to inspections started on or after 1 July 2024.
(2) The amendments of clause 1 of Schedule 1 made by the Narcotic Drugs Amendment (Fees) Regulations 2024 apply in relation to applications made on or after 1 July 2024.
65 Application provisions relating to the Narcotic Drugs Amendment (Fees) Regulations 2025
(1) The amendments of subsection 24(4) and clause 1 of Schedule 1, made by the Narcotic Drugs Amendment (Fees) Regulations 2025 (the amending regulations), apply in relation to applications made on or after 1 July 2025.
(2) The amendment of subsection 54(1) made by the amending regulations applies to inspections commenced on or after 1 July 2025.