Source: https://www.legislation.gov.au/Details/F2018C00112
Timestamp: 2019-10-22 11:08:41
Document Index: 265987911

Matched Legal Cases: ['art 2', 'art 3', 'art 2', 'art 3', 'art 4', 'art 5', 'art 6', 'art 2', 'art 3', 'art 4', 'art 2', 'art 3', 'art 4']

Details: F2018C00112
- F2018C00112
Regulations as amended, taking into account amendments up to Narcotic Drugs Amendment (Cannabis) Regulations 2018
Narcotic Drugs Amendment (Cannabis) Regulations 2018 - F2018L00106
Registered 20 Feb 2018
F2018C00112
Part 2—Licensing the cultivation of cannabis plants and the production of cannabis etc.
Part 3—Licensing the manufacturing of drugs
Includes amendments up to: F2018L00106
Registered: 20 February 2018
This is a compilation of the Narcotic Drugs Regulation 2016 that shows the text of the law as amended and in force on 14 February 2018 (the compilation date).
4A......... Prescription of substances............................................................................................. 2
Part 2—Licensing the cultivation of cannabis plants and the production of cannabis etc. 4
Division 1—Medicinal cannabis licences and permits 4
5............ Application for medicinal cannabis licence—information requirements........................ 4
6............ Application for medicinal cannabis licence—document requirements......................... 10
7............ Application fee for medicinal cannabis licences........................................................... 10
7A......... Application for medicinal cannabis licence—general grounds for refusal of licence... 11
7B......... Application for medicinal cannabis licence—particular grounds for refusal of licence 11
8............ Application for medicinal cannabis permit—information requirements....................... 11
9............ Application for medicinal cannabis permit—document requirements.......................... 12
10.......... Application fee for medicinal cannabis permit............................................................. 13
Division 2—Cannabis research licences and permits 14
11.......... Application for cannabis research licence—information requirements........................ 14
12.......... Application for cannabis research licence—document requirements........................... 20
13.......... Application fee for cannabis research licence.............................................................. 21
13A....... Application for cannabis research licence—general grounds for refusal of licence..... 21
14.......... Application for cannabis research permit—information requirements......................... 21
15.......... Application for cannabis research permit—document requirements............................ 22
16.......... Application fee for cannabis research permit............................................................... 23
17.......... Matters to be specified in cannabis research permit..................................................... 23
Division 3—Conditions of cannabis licences 24
18.......... Condition that cannabis licence holder employ or engage suitable staff....................... 24
19.......... Condition that medicinal cannabis licence holder be party to certain contracts............. 24
20.......... Condition that cannabis licence holder notify the Secretary of certain matters............. 26
Division 4—Variation, suspension and surrender of cannabis licences and cannabis permits 29
Subdivision A—Variation of cannabis licences and permits 29
21.......... Circumstances in which a cannabis licence or cannabis permit must not be varied...... 29
22.......... Application for variation of cannabis licence or permit—information requirements.... 29
23.......... Application for variation of cannabis licence or permit—document requirements....... 29
24.......... Application fee for variation of cannabis licence or permit.......................................... 29
Subdivision B—Suspension of cannabis licences and permits 29
25.......... Suspension of cannabis licences and permits.............................................................. 29
26.......... Secretary may suspend cannabis licences and permits................................................. 29
27.......... Secretary may permit specified production to occur during suspension of cannabis licence or permit 30
28.......... Secretary to notify of proposed suspension of cannabis licence or permit................... 31
29.......... Effect of suspension of cannabis licence or permit...................................................... 31
30.......... Revocation of suspension of cannabis licence or permit.............................................. 32
31.......... Matters not affected by suspension of cannabis licence or permit............................... 33
32.......... Offence and civil penalty—breach of condition of permitted production during suspension 33
Subdivision C—Surrender of cannabis licences and permits 34
33.......... Surrender of cannabis licences and permits................................................................. 34
34.......... Licence holder may surrender cannabis licence or permit............................................ 34
Part 3—Licensing the manufacturing of drugs 36
Division 1—Manufacture licences and permits 36
35.......... Application for manufacture licence—information requirements................................. 36
36.......... Application for manufacture licence—document requirements.................................... 41
36A....... Application for manufacture licence—general grounds for refusal of licence.............. 42
37.......... Particular rules about manufacture licences involving cannabis etc.—medicinal cannabis products 42
38.......... Application for manufacture permit—information requirements................................. 43
Division 2—Conditions of manufacture licences 44
39.......... Condition that manufacture licence holder employ or engage suitable staff................. 44
40.......... Condition that manufacture licence holder notify the Secretary of certain matters....... 44
Division 3—Variation, suspension and surrender of manufacture licences and manufacture permits 46
Subdivision A—Variation of manufacture licences and permits 46
41.......... Circumstances in which a manufacture licence or permit must not be varied............... 46
42.......... Application for variation of manufacture licence or permit—information requirements 46
43.......... Application for variation of manufacture licence or permit—document requirements. 46
Subdivision B—Suspension of manufacture licences and permits 46
44.......... Suspension of manufacture licences and permits......................................................... 46
45.......... Secretary may suspend manufacture licences and permits........................................... 46
46.......... Secretary to notify of proposed suspension of manufacture licence or permit............. 47
47.......... Effect of suspension of manufacture licence or permit................................................ 48
48.......... Revocation of suspension of manufacture licence or permit........................................ 48
49.......... Matters not affected by suspension of manufacture licence or permit.......................... 48
Subdivision C—Surrender of manufacture licences and permits 49
50.......... Surrender of manufacture licences and permits........................................................... 49
51.......... Licence holder may surrender manufacture licence or permit...................................... 49
Part 4—Review of decisions 51
52.......... Reviewable decisions.................................................................................................. 51
Part 5—Other matters 52
Division 1—Fees 52
53.......... Reduction of fees......................................................................................................... 52
54.......... Inspection fees............................................................................................................. 52
Division 1A—Charges 53
54A....... Classes of cannabis research licences for the purposes of charge................................ 53
54B....... When charge is payable............................................................................................... 53
54C....... Recovery of charge...................................................................................................... 53
Division 2—Other matters 55
55.......... Secretary to notify States and Territories of certain matters......................................... 55
56.......... Modification of operation of Chapters 2 and 3 of the Act........................................... 55
Part 6—Application, saving and transitional provisions 56
57.......... Application provisions relating to the Narcotic Drugs Amendment (Cannabis) Regulations 2018 56
Schedule 1—Fees 58
1............ Table of application fees.............................................................................................. 58
This is the Narcotic Drugs Regulation 2016.
(a) business associate;
(c) cannabis plant;
(e) drug;
(f) licensed premises;
(g) medicinal cannabis product;
(h) premises;
(i) relevant financial interest;
(j) relevant position;
(k) supply.
Act means the Narcotic Drugs Act 1967.
affected by bankruptcy: an applicant for a licence is affected by bankruptcy if the applicant has ever:
(a) become bankrupt; or
(b) applied to take the benefit of any law for the relief of bankrupt or insolvent debtors; or
(c) compounded with his or her creditors; or
(d) assigned his or her remuneration for the benefit of creditors; or
(e) executed a personal insolvency agreement under Part X of the Bankruptcy Act 1966.
category A document, in relation to an applicant for a licence, means:
(a) a birth certificate issued by a State or a Territory; or
(b) a current passport issued by the Commonwealth; or
(c) a citizenship certificate issued by the Commonwealth, or documentary evidence that the applicant has been registered by the Commonwealth as an Australian citizen by descent; or
(d) a current passport issued by a foreign government.
category B document, in relation to an applicant for a licence, means:
(a) a driver’s licence or a learner’s permit, issued under a law of a State or a Territory, that includes a photograph of the applicant, the applicant’s signature and a street address that is the same as the address stated in the application for the licence; or
(b) a medicare card; or
(c) documentary evidence that the applicant is an Australian permanent resident within the meaning of the Migration Act 1958.
certified true copy: a copy of a document is a certified true copy of the document if the copy is certified to be a true copy by a person who is prescribed under regulation 4 of the Statutory Declarations Regulations 1993.
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.
identification document means a category A document or a category B document.
starting material, in relation to a drug, means a raw material, an intermediate substance, or a form of a drug substance, that is used in the production of the drug.
Note: A starting material may be a plant, cannabis, cannabis resin or other substances that are drugs.
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.
(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;
Note: Under subsection 8E(1) of the Act, an applicant is not restricted to applying for a licence authorising activities expressly mentioned in that subsection and may, in accordance with paragraph 8E(1)(c) of the Act, apply for a licence authorising activities related to cultivation or production. Such activities could include, for example, testing cannabis to determine the concentration of tetrahydrocannabinol in the leaves and flowering heads of cannabis plants, or the transport of such plants to persons carrying out testing of the plants for the purposes of supply.
(g) the following details of the location where the activities will be undertaken under the licence:
(i) the address of the premises at which the obtaining or cultivation of cannabis plants, and the production of cannabis or cannabis resin, as the case requires, will be undertaken;
(ii) the address of the premises at which other activities relating to such obtaining, cultivation or production 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 land, premises and facilities at the location for the purposes of the Secretary inspecting the land, premises and facilities;
(h) details of the arrangements that will be in place to ensure the physical security of:
(i) cannabis plants cultivated or obtained under the licence; or
(ii) cannabis or cannabis resin produced under the licence;
(i) details of the arrangements that will be in place to ensure that loss or theft of:
is detected and reported immediately after detection;
(j) details of the arrangements that will be in place to ensure the safe and secure disposal or destruction of:
(k) details of the arrangements that will be in place to ensure the safety and security of the supply, delivery and transportation (including storage during transportation) of cannabis plants, cannabis or cannabis resin;
(l) details of the arrangements that will be in place with emergency services, police and local government authorities to deal with the loss, theft, spoilage, disposal or destruction of:
(m) if the application is for a licence that will authorise the cultivation of cannabis plants for the purposes of producing cannabis or cannabis resin but will not also authorise the production of cannabis or cannabis resin—details of the arrangements that will be in place between:
(ii) the holder of a medicinal cannabis licence that authorises such production;
for the supply of the cannabis plants to the holder for the purposes of such production;
(n) if the application is for a licence that authorises the production of cannabis or cannabis resin (whether or not the licence is also proposed to authorise cultivation)—details of the arrangements that will be in place between:
(ii) the holder of a manufacture licence;
for the supply of the cannabis or cannabis resin to the holder for either or both of the following purposes:
(iii) the manufacture of one or more drugs that are medicinal cannabis products;
(iv) the manufacture of a drug for the purposes of research relating to medicinal cannabis products;
(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:
(ii) the length of the connection or association with the person;
(iii) 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):
(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:
(h) details of the applicant’s previous business experience;
(i) if the applicant holds any professional qualifications issued under a law of the Commonwealth, a State or a Territory—details of any disciplinary or other action that is being, or has ever been, taken against the applicant by a person or body that is empowered to take such disciplinary action;
(j) whether the applicant is affected by bankruptcy;
(k) details of the applicant’s current financial circumstances including, but not limited to, financial circumstances that may significantly limit the applicant’s capacity to comply with the applicant’s obligations under a licence;
(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:
(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;
(i) if a director or officer of the body corporate holds any professional qualifications issued under a law of the Commonwealth, a State or a Territory—details of any disciplinary or other action that is being, or has ever been, taken against the director or officer by a person or body that is empowered to take such disciplinary action;
(j) details of the body corporate’s current financial circumstances including, but not limited to, financial circumstances that may significantly limit the capacity of the body corporate to comply with its obligations under a licence;
(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.
Information about record‑keeping arrangements
(5) The application must also contain details of the arrangements that will be in place to record the following, as applicable:
(a) the amount of cannabis plants that the applicant cultivates or obtains during the period of the licence;
(b) the amount of cannabis plants that the applicant maintains for the purposes of propagation during the period of the licence;
(c) the amount of cannabis and cannabis resin that the applicant produces and stores during the period of the licence;
(d) the amount of cannabis plants, cannabis or cannabis resin that the applicant supplies to the holder of a manufacture licence, or a medicinal cannabis licence that authorises the production of cannabis or cannabis resin, during the period of the licence;
(e) the amount of cannabis plants, cannabis or cannabis resin that the applicant destroys or disposes of during the period of the licence.
Information about procedures for employing or engaging suitable staff
(6) The application must also contain details of the procedures (including recruitment procedures) that will be used by the applicant to ensure compliance with subsection 10F(1) of the Act in relation to the employment or engagement of persons to carry out activities authorised by the licence.
Information about security arrangements
(7) The application must also contain details of the following:
(a) the security arrangements that will be in place to deal with the following matters:
(i) the prevention of unauthorised access to the location, premises or facilities where the activities will be undertaken;
(ii) the prevention of unauthorised access to any areas within premises or facilities where cannabis plants, cannabis or cannabis resin will be stored;
(b) the arrangements that will be in place to control all persons (including staff and contractors):
(i) entering the location, premises or facilities where the activities will be undertaken; or
(ii) entering areas within the premises or facilities where cannabis plants, cannabis or cannabis resin will be stored; or
(iii) having access to cannabis plants, cannabis or cannabis resin at the location or in the premises or facilities at the location;
(c) the equipment (such as visual monitoring equipment, visual recording devices and intrusion detection systems) and any other arrangements that will be used to prevent, monitor, detect and record unauthorised access to:
(i) the location and any premises or facilities at the location; and
(ii) cannabis plants, cannabis or cannabis resin at the location or in the premises or facilities at the location.
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:
(a) if the applicant is a natural person—certified true copies of 3 identification documents identifying the applicant, at least one of which must be a category A document;
(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 for either or both of the following:
(i) cultivation of cannabis plants;
(ii) production of cannabis or cannabis resin;
(d) a detailed floor plan of the premises and facilities at the location where the activities will be undertaken;
(e) a copy of the standard operating procedures and policies that will be used to undertake the activities;
(f) a risk management plan that will be used 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).
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.
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.
(b) the licence number of the medicinal cannabis licence held by the applicant;
(c) the activities, in relation to cultivation or production, or cultivation and production, that are proposed to be authorised by the licence in accordance with the permit.
Medicinal cannabis permits—cultivation
(3) An application for a medicinal cannabis permit that relates to a licence that authorises the cultivation of cannabis plants must also contain the following information:
(a) the types and strains of cannabis plants (the proposed plants) proposed to be cultivated in accordance with the permit;
(b) the range of concentration of tetrahydrocannabinol and cannabidiol that will be contained in the proposed plants;
(c) if the proposed plants will contain other cannabinoids that will be used as the active components, or one of the active components, in a medicinal cannabis product—the range of concentration of those other cannabinoids;
(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;
(h) details of the source (whether in Australia or in another country) of the proposed plants, including:
(i) the name, address and contact details of the supplier of the plants; and
(ii) the amount of plants proposed to be supplied by the supplier during the period of the permit; and
(iii) if any plants will be propagated by the applicant from existing plants in the applicant’s possession during the period of the permit—the number of plants proposed to be so propagated.
Medicinal cannabis permits—production
(4) An application for a medicinal cannabis permit that relates to a 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, including for the lawful supply of cannabis or cannabis resin;
(c) the period during which cannabis or cannabis resin is proposed to be produced in accordance with the permit.
9 Application for medicinal cannabis permit—document requirements
(1) For the purposes of paragraph 8P(2)(c) of the Act, the documents specified in this section are prescribed as the documents that must accompany an application by the holder of a medicinal cannabis licence (the applicant) for a medicinal cannabis permit.
(a) copies of all relevant contracts that are in place between the applicant and the holder of a licence under the Act that authorises:
(i) the supply of cannabis plants; or
(ii) the production of cannabis or cannabis resin; or
(iii) the manufacture of one or more drugs that are medicinal cannabis products; or
(b) if the applicant proposes to cultivate cannabis plants in accordance with the permit—evidence of the following:
(i) the types and strains of cannabis plants proposed to be cultivated;
(ii) the range of concentration of tetrahydrocannabinol, cannabidiol and other cannabinoids that are likely to be contained in the cannabis plants proposed to be cultivated.
Note: The evidence could be in the form of a certificate issued by a government authority, a government accredited laboratory or the supplier of the cannabis plants.
10 Application fee for medicinal cannabis permit
For the purposes of subsection 8P(3) of the Act, the application fee set out in the table in clause 1 of Schedule 1 for a medicinal cannabis permit is prescribed.
Division 2—Cannabis research licences and permits
11 Application for cannabis research licence—information requirements
(1) For the purposes of paragraph 9D(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 cannabis research licence.
(f) details of the activities the applicant proposes to undertake under the licence, being activities mentioned in subsection 9D(1) of the Act;
Note: Under subsection 9D(1) of the Act, an applicant is not restricted to applying for a licence authorising activities expressly mentioned in that subsection and may, in accordance with paragraph 9D(1)(c) of the Act, apply for a licence authorising activities related to cultivation or production. Such activities could include, for example, testing cannabis to determine the concentration of tetrahydrocannabinol in the leaves and flowering heads of cannabis plants, or the transport of such plants to persons carrying out testing of the plants for the purposes of supply.
(fa) if the applicant seeks a decision of the Secretary under subsection 54A(2) in relation to the research that the applicant proposes to undertake under the licence—the following details about the research:
(i) the primary purpose of the research;
(ii) who will benefit from the research;
(iii) how any products that may be developed as a result of the research will be used;
(iv) the source of the funds for the research;
(v) who owns or operates the research facilities in which the research will be undertaken;
(g) if the application is for a licence that will authorise the cultivation of cannabis plants—details of how the research that the applicant proposes to undertake relates to medicinal cannabis;
(h) if the application is for a licence that will authorise the production of cannabis or cannabis resin—details of how the research that the applicant proposes to undertake relates to medicinal cannabis or medicinal cannabis products;
(i) details of the applicant’s financial resources, other resources and expertise that will enable the applicant to carry out the research mentioned in paragraphs (g) and (h) (as applicable);
(j) the following details of the location where the activities will be undertaken under the licence:
(k) details of the arrangements that will be in place to ensure the physical security of:
(l) details of the arrangements that will be in place to ensure that loss or theft of:
(m) details of the arrangements that will be in place to ensure the safe and secure disposal or destruction of:
(n) details of the arrangements that will be in place to ensure the safety and security of the supply, delivery and transportation (including storage during transportation) of cannabis plants, cannabis or cannabis resin;
(o) details of arrangements that will be in place with emergency services, police and local government authorities to deal with the loss, theft, spoilage, disposal or destruction of:
(p) if applicable, details of an approval from a research committee, or a research grant issued by a research institution or government organisation, in relation to the medicinal cannabis research;
(q) whether the applicant has applied, or proposes to apply, for any other licence under the Act and, if so, the kind of licence.
(d) the amount of cannabis plants, cannabis or cannabis resin that the applicant destroys or disposes of during the period of the licence;
(e) the amount of cannabis plants, cannabis or cannabis resin that the applicant supplies to the holder of a manufacture licence, or a medicinal cannabis licence that authorises the production of cannabis or cannabis resin, during the period of the licence.
12 Application for cannabis research licence—document requirements
(1) For the purposes of paragraph 9D(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 cannabis research licence.
13 Application fee for cannabis research licence
For the purposes of subsection 9D(3) of the Act, the application fee set out in the table in clause 1 of Schedule 1 for a cannabis research licence is prescribed.
14 Application for cannabis research permit—information requirements
(1) For the purposes of paragraph 9N(2)(a) of the Act, the information specified in this section is prescribed in relation to an application by the holder of a cannabis research licence (the applicant) for a cannabis research permit.
(b) the licence number of the cannabis research licence held by the applicant;
(c) the activities, in relation to cultivation or production, or cultivation and production, that are proposed to be authorised by the licence in accordance with the permit;
(d) if one of those activities is an activity covered by subparagraph 9D(1)(c)(ia) of the Act—the following information:
Cannabis research permits—cultivation
(3) An application for a cannabis research permit that relates to a licence that authorises the cultivation of cannabis plants must also contain the following information:
Cannabis research permits—production
(4) An application for a cannabis research permit that relates to a 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 proposed to be produced in accordance with the permit;
(b) the maximum quantity of cannabis or cannabis resin that it is necessary for the licence holder to produce at any time for conducting the research authorised by the licence;
(c) the period during which the cannabis or cannabis resin is proposed to be produced in accordance with the permit.
15 Application for cannabis research permit—document requirements
(1) For the purposes of paragraph 9N(2)(c) of the Act, the documents specified in this section are prescribed as the documents that must accompany an application by the holder of a cannabis research licence (the applicant) for a cannabis research permit.
16 Application fee for cannabis research permit
For the purposes of subsection 9N(3) of the Act, the application fee set out in the table in clause 1 of Schedule 1 for a cannabis research permit is prescribed.
17 Matters to be specified in cannabis research permit
Cannabis research permit—cultivation
(1) For the purposes of paragraph 10A(1)(f) of the Act, the following matters are prescribed:
(a) the research activity that may be undertaken in relation to particular types or strains of cannabis plants;
(b) the purpose of the research that may be undertaken.
Cannabis research permit—production
(2) For the purposes of paragraph 10A(2)(e) of the Act, the following matters are prescribed:
(a) the research activity that may be undertaken in relation to cannabis or cannabis resin;
Division 3—Conditions of cannabis licences
18 Condition that 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:
(a) persons who are undertaking, or who have undertaken, treatment for drug addiction;
(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 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 mentioned in that subsection:
(a) the types and strains of cannabis plants to be supplied;
(b) the range of concentration of tetrahydrocannabinol and cannabidiol that will be contained in the cannabis plants to be supplied;
(c) the number of cannabis plants to be supplied;
(d) the delivery, dealing in any way with, transportation, storage, security or disposal of cannabis plants to be supplied.
Licences authorising production
(2) For the purposes of subsection 10J(2) of the Act, the following matters are prescribed as matters that must be dealt with by a contract mentioned in that subsection:
(a) the types and strains of cannabis plants to be used to produce the cannabis or cannabis resin to be supplied;
(b) the range of concentration of tetrahydrocannabinol, cannabidiol and other cannabinoids that will be contained in the cannabis plants to be used to produce the cannabis or cannabis resin to be supplied;
(c) the number of cannabis plants proposed to be used to produce the cannabis or cannabis resin to be supplied;
(d) the delivery, dealing in any way with, transportation, storage, security or disposal of the cannabis or cannabis resin to be supplied;
(e) the parts of cannabis plants that are to be used for the production of the cannabis or cannabis resin to be supplied;
(f) the quantity of cannabis or cannabis resin to be supplied;
(g) the part or parts of the cannabis plants to be used for the manufacture of the medicinal cannabis product.
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) 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) are prescribed as circumstances in which a contract referred to in subsection 10J(2) of the Act is not required to be in existence.
(7) For the purposes of subsection (6), the circumstances are that:
(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 a licence under the Act that authorises the manufacture of one or more drugs that are medicinal cannabis products or the manufacture of a drug for the purposes of research in relation to medicinal cannabis products;
has ceased to be in existence and the first licence holder is taking steps to arrange a new contract with another holder of a licence under the Act that authorises such manufacture; or
(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.
20 Condition that 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 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 or cannabis resin from the location, premises or facilities covered by the licence;
(c) a loss, or a suspected loss, of cannabis plants, cannabis or cannabis resin 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 or cannabis resin in the possession or under the control of the licence holder;
(e) a loss, or a suspected loss, of cannabis plants, cannabis or cannabis resin 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 or cannabis resin;
(f) a serious incident involving cannabis plants, cannabis or cannabis resin in the possession or under the control of the licence holder during transportation of the cannabis plants, cannabis or cannabis resin;
(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 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 ceases to undertake, or proposes to cease undertaking, cultivation, production or any other activities 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
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:
is no longer in existence or is proposed to be terminated.
Division 4—Variation, suspension and surrender of cannabis licences and cannabis permits
Subdivision A—Variation of cannabis licences and permits
21 Circumstances in which a cannabis licence or cannabis permit must not be varied
For the purposes of paragraph 10M(3)(b) of the Act, a cannabis licence or cannabis permit must not be varied on application by a licence holder if, had the proposed variation been included as part of the application for a cannabis licence, the Secretary would have been required to refuse to grant the licence under section 8G, 8J, 9F or 9H of the Act.
22 Application for variation of cannabis licence or permit—information requirements
For the purposes of paragraph 10N(1)(a) of the Act, an application by the holder of a cannabis licence for a variation of the cannabis licence or a 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 cannabis licence or permit—document requirements
For the purposes of paragraph 10N(1)(c) of the Act, an application by the holder of a cannabis licence for a variation of the cannabis licence or a cannabis permit that relates to the licence must be accompanied by documents that support the application.
24 Application fee for variation of cannabis licence or permit
For the purposes of subsection 10N(2) of the Act, the application fee set out in the table in clause 1 of Schedule 1 for a variation of a cannabis licence or cannabis permit is prescribed.
Subdivision B—Suspension of cannabis licences and permits
25 Suspension of cannabis licences and permits
For the purposes of section 11A of the Act, this Subdivision makes provision for and in relation to the suspension of cannabis licences and cannabis permits.
26 Secretary may suspend cannabis licences and permits
(1) The Secretary may, by notice in writing given to the holder of a cannabis licence, suspend the licence, or a 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 cannabis licence or a 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 cannabis licence; or
(b) if the Secretary is satisfied on reasonable grounds that there is a risk that cannabis plants, cannabis or cannabis resin 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.
(4) If a cannabis licence is suspended, any cannabis permit that relates to the licence is taken to be suspended at the time of the suspension 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 ceases to be in force during the period of suspension—on the day the licence ceases to be in force;
(c) if the suspension is revoked—on the day the suspension is revoked.
(6) The period of suspension must not be more than 6 months and must be set out in the notice under subsection (1).
27 Secretary may permit specified production to occur during suspension of cannabis licence or permit
Specified production may be permitted while cannabis licence is suspended
(1) If a cannabis licence that authorises the production of cannabis or cannabis resin is suspended, the Secretary may, in the notice under subsection 26(1), permit the licence holder to engage in specified production of cannabis or cannabis resin during the period of the suspension in accordance with conditions specified in the notice.
Specified production may be permitted while cannabis permit is suspended
(2) If a cannabis permit that relates to a cannabis licence that authorises the production of cannabis or cannabis resin in accordance with the permit is suspended, the Secretary may, in the notice under subsection 26(1), permit the permit holder to engage in specified production of cannabis or cannabis resin authorised by the licence in accordance with the permit during the period of the suspension in accordance with conditions specified in the notice.
28 Secretary to notify of proposed suspension of cannabis licence or permit
(1) Before suspending under section 26 a cannabis licence, or a cannabis permit that relates to a 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 cannabis licence or a 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 cannabis licence or a cannabis permit, the Secretary must have regard to any submission made under paragraph (3)(b).
29 Effect of suspension of cannabis licence or permit
(1) During the period of suspension of a cannabis licence or cannabis permit, the licence or permit has no force or effect, but the period of currency of the licence or permit continues to run.
Effect of suspension of cannabis licence
(2) Despite subsection (1), if, under section 26, the Secretary suspends a cannabis licence that authorises either or both of the following activities:
(a) the cultivation of cannabis plants (whether or not it also authorises the obtaining of cannabis plants for the purposes of such cultivation);
(b) the production of cannabis or cannabis resin;
the following provisions have effect during the period of suspension:
(c) if the licence authorises the cultivation of cannabis plants—the licence holder is authorised to 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;
(d) if the licence authorises the production of cannabis or cannabis resin—the licence holder is authorised to engage in the production of cannabis or cannabis resin if, but only if, under section 27, the Secretary permits that production to occur in accordance with conditions specified in the notice of suspension.
Effect of suspension of cannabis permit
(3) Despite subsection (1), if, under section 26, the Secretary suspends a cannabis permit that relates to a cannabis licence that authorises either or both of the following activities:
(c) if the permit relates to a licence that authorises the cultivation of cannabis plants—the permit holder is authorised to tend, nurture, harvest or store cannabis plants covered by the permit and in the permit holder’s possession or control at the time of the suspension of the permit;
(d) if the permit relates to a licence that authorises the production of cannabis or cannabis resin—the permit holder is authorised to engage in the production of cannabis or cannabis resin covered by the permit if, but only if, under section 27, the Secretary permits that production to occur in accordance with conditions specified in the notice of suspension.
(4) The suspension of a cannabis licence or cannabis permit does not prevent the revocation of the licence or permit.
30 Revocation of suspension of cannabis licence or permit
(1) If a cannabis licence, or a cannabis permit that relates to the licence, is suspended, the Secretary may revoke the suspension, by written notice given to the licence holder:
(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 cannabis licence or permit
(1) To avoid doubt, the following continue to have effect according to their terms during a period of suspension of a cannabis licence or a cannabis permit that relates to the licence:
(a) a condition to which the 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 cannabis licence, or a 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 production during suspension
(a) the person is the holder of a cannabis licence; and
(b) the licence authorises the production of cannabis or cannabis resin in accordance with a cannabis permit; and
(c) the cannabis licence or cannabis permit is suspended under subsection 26(1); and
(d) under section 27 the Secretary permits specified production of cannabis or cannabis resin to occur during the period of suspension in accordance with conditions specified in the notice under subsection 26(1); and
(e) the person fails to comply with a condition.
Note: If a body corporate contravenes subsection (1), subsection 82(5) of the Regulatory Powers (Standard Provisions) Act 2014 allows a court to order the body corporate to pay a pecuniary penalty of up to 5 times the pecuniary penalty stated above.
Subdivision C—Surrender of cannabis licences and permits
33 Surrender of cannabis licences and permits
For the purposes of section 11A of the Act, this Subdivision makes provision for and in relation to the surrender of cannabis licences and cannabis permits.
34 Licence holder may surrender cannabis licence or permit
(1) The holder of a cannabis licence or 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, being a day that is not less than 20 business days after the day the notice is given to the Secretary;
(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, cannabis or cannabis resin (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 licence under the Act—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 or production 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.
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.
(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 drugs proposed to be manufactured;
(h) 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.
(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 drugs will be manufactured;
(ii) the address of the premises at which other activities relating to such manufacture will be undertaken;
(j) details of the arrangements that will be in place to ensure the physical security of drugs manufactured under the licence and starting materials used in such manufacture;
(k) details of the arrangements that will be in place to ensure that loss or theft of drugs manufactured under the licence, or starting materials used in such manufacture, is detected and reported immediately after detection;
(l) details of the arrangements that will be in place to ensure the safe and secure disposal or destruction of drugs manufactured under the licence and starting materials used in such manufacture;
(m) details of the arrangements that will be in place to ensure the safety and security of the supply, delivery and transportation (including storage during transportation) of drugs manufactured under the licence and starting materials used in such manufacture;
(n) details of arrangements that will be in place with emergency services, police and local government authorities to deal with loss, theft, spoilage, disposal or destruction of drugs manufactured under the licence and starting materials used in such manufacture;
(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;
(a) the quantities of drugs that the applicant manufactures under the licence;
(b) the amount of starting material in the possession of, or under the control of, the applicant at any time for the manufacture of drugs under the licence.
(6) The application must also contain details of the procedures (including recruitment procedures) that will be used by the applicant to ensure compliance with subsection 12H(1) of the Act in relation to the employment or engagement of persons to carry out activities authorised by the manufacture licence.
(a) the security arrangements that the will be in place to deal with the following matters:
(ii) the prevention of unauthorised access to all areas within the premises or facilities where drugs manufactured under the licence will be stored;
(i) entering the location, premises or facilities where the activities will be undertaken; and
(ii) entering areas within the premises or facilities where drugs manufactured under the licence will be stored; and
(iii) having access to drugs manufactured under the licence;
(c) the equipment (such as visual monitoring equipment, visual recording devices and intrusion detection systems) and any other arrangements that will be used to monitor, detect and prevent unauthorised access to:
(ii) drugs manufactured under the licence.
Additional information required if applicant proposes to manufacture medicinal cannabis product for research, clinical trial or supply to the public
(8) If the applicant proposes to manufacture a drug that includes, or is derived from, any part of a cannabis plant, the application must also contain the following:
(a) if the drug is for the purpose of research relating to medicinal cannabis products—information about:
(i) the research proposed to be carried out and the purpose of such research; and
(ii) the applicant’s financial resources and other resources to enable the applicant to carry out such research; and
(iii) the qualifications and expertise of the persons employed or engaged by the applicant to carry out such research;
(b) if the drug is a medicinal cannabis product—information about:
(i) if the product is to be used in a clinical trial—the clinical trial in which the product is to be used; or
(ii) if the drug is to be supplied to the public—information about the authority or approval under the Therapeutic Goods Act 1989 under which the supply is to occur; or
(iii) if the drug is to be supplied to a person as mentioned in paragraph 37(c)—details of that supply and details of any arrangements in place between the applicant and that person relating to the proposed end use of the medicine referred to in that paragraph.
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.
(c) a site plan showing how land at the location where the activities will be undertaken will be utilised;
(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.
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.
(b) the licence number of the manufacture licence held by the applicant;
(c) details of the drugs proposed to be manufactured;
(d) details of the proposed end use of the manufactured drugs;
(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 drugs;
(f) details of the maximum quantities of the drugs that are proposed to be manufactured;
(g) details of the maximum quantities of the drugs 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 drugs are 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
(1) Each of the following classes of persons is prescribed for the purposes of paragraph 12H(1)(d) of the Act:
(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:
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:
(b) a theft, or a suspected theft, of drugs or starting material from the location, premises or facilities covered by the licence;
(c) a loss, or a suspected loss, of drugs or starting material at the location, premises or facilities covered by the licence;
(d) a discrepancy, or a suspected discrepancy, in the quantity of drugs or starting material in the possession or under the control of the licence holder;
(e) a loss, or a suspected loss, of drugs or starting material 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 drugs or starting material;
(f) a serious incident involving drugs or starting material in the possession or under the control of the licence holder during transportation of the drugs or starting material;
(ii) a new condition imposed on the manufacture licence under the Act;
(iii) a variation of the licence or of a permit that relates to the licence;
(i) the licence holder commences to manufacture drugs under the licence;
(j) the licence holder ceases to manufacture drugs, or ceases to undertake any other activities, under 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.
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 permit must not be varied
For the purposes of paragraph 13(3)(b) of the Act, a manufacture licence or manufacture permit must not be varied on application by a licence holder if, had the proposed variation been included as part of the application for a manufacture licence, the Secretary would have been required to refuse to grant the licence under section 11J or 11K 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 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).
(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 drugs or narcotic preparations or starting materials 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.
(4) If a manufacture licence is suspended, any manufacture permit that relates to the licence is taken to be suspended at the time of the suspension of the licence.
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:
(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).
47 Effect of suspension of manufacture licence or permit
(1) During the period of suspension of a manufacture licence or manufacture permit, the licence or permit has no force or effect, but the period of currency of the licence or permit continues to run.
(2) Despite subsection (1), if, under section 45, the Secretary suspends a manufacture licence that authorises the manufacture of a drug, the licence holder is authorised during the period of suspension to store, possess and control any drugs, narcotic preparations or starting materials in the licence holder’s possession or control as authorised by the licence at the time of the suspension.
(3) The suspension of a manufacture licence or manufacture permit does not prevent the revocation of the licence or permit.
48 Revocation of suspension of manufacture licence or permit
(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:
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 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.
(a) details of the manufacture licence or manufacture permit being surrendered;
(e) details of the manner in which any drugs, narcotic preparations or starting materials (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;
(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;
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 cannabis licence or a cannabis permit that relates to the licence;
(b) a decision under subsection 27(1) to refuse to permit specified production of cannabis or cannabis resin during a period of suspension of a cannabis licence;
(c) a decision under subsection 27(2) to refuse to permit specified production of cannabis or cannabis resin during a period of suspension of a cannabis permit;
(d) a decision under section 30 to refuse to revoke a suspension of a cannabis licence or a 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 subsection 54A(2) about whether research that an applicant proposes to undertake will be undertaken for non‑commercial purposes, or primarily for non‑commercial purposes.
Division 1—Fees
53 Reduction of fees
(1) The Secretary may reduce by up to 75% the amount of an application fee specified in the table in clause 1 of Schedule 1 that is payable by an applicant in relation to an application of a kind mentioned in an item in the table if the following apply:
(a) the applicant makes an application for a medicinal cannabis licence and a cannabis research licence at the same time;
(b) the activities proposed to be authorised by each licence will be undertaken at the same licensed premises;
(c) the Secretary is reasonably satisfied that the information and documents provided by the applicant in support of each application are sufficiently similar to enable assessment of each application to be undertaken simultaneously.
(2) The reduced application fee applies only to one of the applications.
54 Inspection fees
(1) If an inspection of land or premises is conducted in relation to an application for:
(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 $470 in respect of each person conducting the inspection is payable for each hour, or part of an hour, the person spends conducting 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 cannabis research licences for the purposes of charge
Commercial cannabis research licence
(1) For the purposes of paragraph 28(1)(e) of the Act, a cannabis research licence is a commercial cannabis research licence if, when granting the licence, the Secretary does not notify the applicant for the licence in accordance with subsection (2).
Non‑commercial cannabis research licence
(2) For the purposes of paragraph 28(1)(e) of the Act, a cannabis research licence is a non‑commercial cannabis research licence if, when granting the licence, the Secretary notifies the applicant for the licence in writing that the Secretary is reasonably satisfied that the research that the applicant proposes to undertake will be undertaken for non‑commercial purposes, or primarily for non‑commercial purposes.
Matters to which the Secretary must have regard
(3) In making a decision under subsection (2) about research that an applicant proposes to undertake, the Secretary must have regard to the following:
(a) the primary purpose of the research;
(b) who will benefit from the research;
(c) how any products that may be developed as a result of the research will be used;
(d) the source of the funds for the research;
(e) who owns or operates the research facilities in which the research will be undertaken.
(4) Subsection (3) does not limit the matters to which the Secretary may have regard in making a decision under subsection (2).
54B When charge is payable
For the purposes of subparagraph 28(1)(e)(i) of the Act, charge payable in respect of a licence:
(a) is payable to the Secretary on behalf of the Commonwealth; and
(b) is due and payable on the day specified in an invoice 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, charge that is due and payable:
(b) may be recovered by the Secretary on behalf of the Commonwealth by action in a court of competent jurisdiction.
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 land or 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);
(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.
Note: See sections 7, 10, 13, 16, 24 and 54.
1 Table of application fees
The following table specifies application fees for applications specified in the table.
Application for a medicinal cannabis licence
Application for a medicinal cannabis permit
Application for a cannabis research licence
Application for a cannabis research permit
Application for a variation of a medicinal cannabis licence
Application for a variation of a medicinal cannabis permit
Application for a variation of a cannabis research licence
Application for a variation of a cannabis research permit
14 Oct 2016 (F2016L01613)
9 Dec 2016 (F2016L01894)
13 Feb 2018 (F2018L00106)
14 Feb 2018 (s 2(1) item 1)
ad F2018L00106
am F2018L00106
am F2016L01894; F2018L00106
rs F2018L00106
am F2016L01894
ad F2016L01894
s 54C........................................