This is the Narcotic Drugs Regulation 2016.

(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1. The whole of this instrument	At the same time as Schedule 1 to the Narcotic Drugs Amendment Act 2016 commences.	29 October 2016

Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under the Narcotic Drugs Act 1967.

4 Definitions

Note: A number of expressions used in this instrument are defined in the Act, including the following:

(a) business associate;

(b) cannabis;

(d) cannabis resin;

(e) drug;

(f) licensed premises;

(g) medicinal cannabis product;

(h) premises;

(i) relevant financial interest;

(j) relevant position;

(k) supply.

In this instrument:

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.

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

(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.

ARBN has the meaning given by section 9 of the Corporations Act 2001.

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.

medicare card has the meaning given by subsection 84(1) of the National Health Act 1953.

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.

Part 2—Licensing the cultivation of cannabis plants and the production of cannabis etc.

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;

(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:

(i) cannabis plants cultivated or obtained under the licence; or

(ii) cannabis or cannabis resin produced under the licence;

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:

(i) cannabis plants cultivated or obtained under the licence; or

(ii) cannabis or cannabis resin produced under the licence;

(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:

(i) cannabis plants cultivated or obtained under the licence; or

(ii) cannabis or cannabis resin produced under the licence;

(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:

(i) the applicant; and

(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:

(i) the applicant; and

(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 (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 person mentioned in paragraph (d) with whom the applicant is connected or associated:

(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;

(f) the name and date of birth of each person who holds a relevant financial interest, or who is entitled to exercise a relevant power (whether in his or her own right or on someone else’s behalf):

(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;

(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;

(n) the applicant’s history of compliance with 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;

(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 (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 person mentioned in paragraph (f) with whom the body corporate, its directors or officers are connected or associated:

(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;

(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;

(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.

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, 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;

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.

(2) The following documents must accompany the application:

(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

(iv) the manufacture of a drug for the purposes of research relating to medicinal cannabis products;

(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.

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;

(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 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.

(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:

(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;

(k) 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;

(l) details of the arrangements that will be in place to ensure that loss or theft of:

(i) cannabis plants cultivated or obtained under the licence; or

(ii) cannabis or cannabis resin produced under the licence;

is detected and reported immediately after detection;

(m) details of the arrangements that will be in place to ensure the safe and secure disposal or destruction of:

(i) cannabis plants cultivated or obtained under the licence; or

(ii) cannabis or cannabis resin produced under the licence;

(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:

(i) cannabis plants cultivated or obtained under the licence; or

(ii) cannabis or cannabis resin produced under the licence;

(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.

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;

(e) the following details in relation to each person mentioned in paragraph (d) with whom the applicant is connected or associated:

(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;

(f) the name and date of birth of each person who holds a relevant financial interest, or who is entitled to exercise a relevant power (whether in his or her own right or on someone else’s behalf):

(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;

(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;

(j) whether the applicant is affected by bankruptcy;

(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;

(n) the applicant’s history of compliance with 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;

(e) the names, and dates of birth, of the directors and officers of the body corporate;

(g) the following details in relation to each person mentioned in paragraph (f) with whom the body corporate, its directors or officers are connected or associated:

(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;

(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;

(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.