Commonwealth: Narcotic Drugs Amendment Act 2016 (Cth)

Narcotic Drugs Amendment Act 2016 No. 12, 2016 An Act to amend the Narcotic Drugs Act 1967, and for related purposes Contents 1 Short title 2 Commencement 3 Schedules Schedule 1—Amendments relating to medicinal cannabis Narcotic Drugs Act 1967 Schedule 2—Amendments relating to authorisation of State and Territory agencies Narcotic Drugs Act 1967 Schedule 3—Transitional provisions Schedule 4—Amendments relating to Schedules Narcotic Drugs Act 1967 Schedule 5—Consequential amendments Therapeutic Goods Act 1989 Narcotic Drugs Amendment Act 2016 No. 12, 2016 An Act to amend the Narcotic Drugs Act 1967, and for related purposes [Assented to 29 February 2016] The Parliament of Australia enacts: 1 Short title This Act may be cited as the Narcotic Drugs Amendment Act 2016. 2 Commencement (1) Each provision of this Act 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. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day this Act receives the Royal Assent. 29 February 2016 2. Schedule 1 A single day to be fixed by Proclamation. 29 October 2016 However, if the provisions do not commence within the period of 8 months beginning on the day this Act receives the Royal Assent, they commence on the day after the end of that period. 3. Schedule 2 The earlier of: 1 May 2016 (a) the start of a single day to be fixed by Proclamation; and (F2016N00004) (b) immediately before the provisions covered by table item 2. 4. Schedules 3 to 5 At the same time as the provisions covered by table item 2. 29 October 2016 Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act. (2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act. 3 Schedules Legislation that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. Schedule 1—Amendments relating to medicinal cannabis Narcotic Drugs Act 1967 1 Title Repeal the title, substitute: An Act to make provision in relation to narcotic drugs in accordance with the Single Convention on Narcotic Drugs, 1961, as in force from time to time, and for other purposes 2 Part I (heading) Repeal the heading, substitute: Chapter 1—Preliminary Part 1—General provisions 3 After section 2 Insert: 2A Object of this Act The object of this Act is to give effect to certain of Australia's obligations under the Single Convention on Narcotic Drugs, 1961, as in force from time to time. 4 Section 3 Repeal the section, substitute: 3 Simplified outline of this Act This Act gives effect to certain of Australia's obligations under the Single Convention on Narcotic Drugs, 1961, as in force from time to time. The Convention, as amended by the 1972 Protocol, is set out in Schedule 1 to this Act. A licensing and permit scheme regulates the cultivation of cannabis plants and the production of cannabis and cannabis resin. Cultivation and production, and related activities, under the scheme are for medicinal purposes or for research relating to medicinal cannabis. A separate licensing and permit scheme regulates the manufacture of drugs covered by the Convention. Authorised inspectors have monitoring, inspection and enforcement powers under the Regulatory Powers Act to ensure this Act is being complied with. The Secretary has comprehensive powers to give directions to licence holders and former licence holders. 5 Subsection 4(1) Repeal the subsection, substitute: (1) In this Act: 1972 Protocol means the Protocol Amending the Single Convention on Narcotic Drugs, 1961, done at Geneva on 25 March, 1972. agency of the Commonwealth, a State or a Territory includes the following: (a) the Crown in right of the Commonwealth, a State or a Territory; (b) a Minister of the Commonwealth, a State or a Territory; (c) a Commonwealth, State or Territory government department; (d) an instrumentality of the Commonwealth, a State or a Territory, including a body corporate established for a public purpose by or under a law of the Commonwealth, a State or a Territory; (e) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together: (i) the Crown in right of the Commonwealth, a State or a Territory; (ii) a person or body covered by paragraph (b) or (d); (f) a court, tribunal or parole board of the Commonwealth, a State or a Territory. authorised inspector means a person appointed as an authorised inspector under section 13H. business associate: 2 or more persons are business associates, in relation to a business, if each person: (a) both: (i) holds a relevant financial interest, or is entitled to exercise a relevant power (whether in his or her own right or on someone else's behalf), in the business; and (ii) because of that interest or power, is able to exercise a significant influence over, or with respect to, the management or operation of the business; or (b) holds any relevant position (whether in his or her own right or on someone else's behalf) in the business. cannabis has the same meaning as in the Convention. cannabis licence means a cannabis research licence or a medicinal cannabis licence. cannabis permit means a cannabis research permit or a medicinal cannabis permit. cannabis plant means the following: (a) any plant of the genus cannabis; (b) any part of a plant of the genus cannabis including, but not limited to, the seeds, stems or leaves of the plant. cannabis research licence: see subsection 9D(1). cannabis research permit: see subsection 9N(1). cannabis resin has the same meaning as in the Convention. civil penalty provision has the same meaning as in the Regulatory Powers Act. coca leaves has the same meaning as in the Convention. Collector has the same meaning as in the Customs Act 1901. Comptroller‑General of Customs means the person who is the Comptroller‑General of Customs in accordance with subsection 11(3) or 14(2) of the Australian Border Force Act 2015. Convention means the Single Convention on Narcotic Drugs, 1961, done at New York on 30 March 1961, as amended by the Protocol and as in force from time to time. Note: A copy of the English text of the Convention, as amended and in force at the commencement of section 1 of the Narcotic Drugs Amendment Act 2016, is set out in Schedule 1. cultivate a cannabis plant includes the following: (a) sow a seed of a cannabis plant; (b) plant, grow, tend, nurture or harvest a cannabis plant; (c) graft, divide or transplant a cannabis plant; but does not include the separation of cannabis or cannabis resin from a cannabis plant. decision on review: see subsection 15H(5). drug means any substance that is a drug for the purposes of the Convention, and includes any substance prescribed by regulations under section 8 of this Act. fit and proper person: see sections 8A and 8B. handling includes stacking, stowing, storing, transporting, loading, unloading and any operation incidental to, or arising out of, any of those operations. head of an agency means: (a) if the agency is a court—the registrar (however described) of the court; or (b) otherwise—the principal officer (however described) of the agency. internal reviewer: see subsection 15H(1). issuing officer means: (a) a Judge of a court created by the Parliament; or (b) a Deputy President of the Administrative Appeals Tribunal; or (c) a non‑presidential member of the Administrative Appeals Tribunal who: (i) is enrolled as a legal practitioner of the High Court, or the Supreme Court of a State or Territory; and (ii) has been so enrolled for at least 5 years. licence means the following: (a) a cannabis research licence; (b) a manufacture licence: (c) a medicinal cannabis licence. licensed premises means premises at which activities authorised under a licence take place. manufacture licence: see subsection 11G(1). manufacture permit: see subsection 12(1). medicinal cannabis licence: see subsection 8E(1). medicinal cannabis permit: see subsection 8P(1). medicinal cannabis product means a product, including but not limited to a substance, composition, preparation or mixture, that: (a) includes, or is from, any part of the cannabis plant; and (b) is for use for the purposes of curing, or alleviating the symptoms of, a disease, ailment or injury. narcotic preparation means any mixture, whether solid or liquid, that contains a drug. offence against this Act includes an offence against the Crimes Act 1914 or the Criminal Code that relates to this Act. opium has the same meaning as in the Convention. permit means the following: (a) a cannabis research permit; (b) a manufacture permit; (c) a medicinal cannabis permit. premises includes the following: (a) a structure or building; (b) a vehicle, vessel or aircraft; (c) a place (whether or not enclosed or built on), including a place situated underground or under water; (d) a part of a thing referred to in paragraph (a), (b) or (c). production has the same meaning as in the Convention. Regulatory Powers Act means the Regulatory Powers (Standard Provisions) Act 2014. relative of a person includes a spouse, parent, step‑parent, child, step‑child, adopted child, sibling or step‑sibling of the person. relevant court means: (a) the Federal Court of Australia; or (b) the Federal Circuit Court of Australia; or (c) a court of a State or Territory that has jurisdiction in relation to matters arising under this Act. relevant financial interest, in relation to a business, means: (a) a share in the capital of the business; or (b) an entitlement to receive any income derived from the business. relevant position, in relation to a business, means a position (however described) of director, partner, trustee, manager or other executive position, or secretary. relevant power, in relation to a business, means any power, whether exercisable by voting or otherwise and whether exercisable alone or in association with others: (a) to participate in any directorial, managerial or executive decision of the business; or (b) to elect or appoint any person to any relevant position in relation to the business. reviewable decision: see section 15E. Secretary means the Secretary of the Department administered by the Minister administering the National Health Act 1953. serious offence means the following: (a) an offence against a law of the Commonwealth, a State, a Territory or another country that: (i) involves dishonesty, fraud or cultivation of, or trafficking in, drugs; and (ii) is punishable by a maximum penalty of imprisonment for not less than 3 months; (b) an offence against a law of the Commonwealth, a State, a Territory or another country that is punishable by a maximum penalty of imprisonment for not less than 5 years. spouse of a person includes: (a) another person (whether of the same sex or a different sex) with whom the person is in a relationship that is registered under a law of a State or Territory prescribed for the purposes of section 2E of the Acts Interpretation Act 1901 as a kind of relationship prescribed for the purposes of that section; and (b) another person who, although not legally married to the person, lives with the person on a genuine domestic basis in a relationship as a couple. supply includes the following, whether free of charge or otherwise: (a) supply by way of sale, exchange, gift, lease, loan, hire or hire‑purchase; (b) supply by way of sample; (c) supply in the course of testing safety or efficacy; (d) supply by way of administration to, or application in the treatment of, a person. this Act includes: (a) instruments made under this Act; (b) the Regulatory Powers Act as it applies because of this Act. (1A) To avoid doubt, a reference to a drug in this Act includes a reference to a medicinal cannabis product that is a drug. 6 Sections 5 and 6 Repeal the sections, substitute: 5 Crown to be bound (1) This Act binds the Crown in each of its capacities. (2) This Act does not make the Crown liable to be prosecuted for an offence. 6 Extension to external Territories This Act extends to every external Territory. 7 Section 7 Omit "section 12 or 13", substitute "this Act". 8 After section 7 Insert: 7A Interaction with State and Territory laws (1) Despite section 7, Chapter 2 and section 25A of this Act, and other provisions of this Act so far as they relate to those provisions, apply to the exclusion of a law, or a provision of a law, of a State or a Territory to the extent that the law or provision purports to do one or more of the following: (a) provide for the grant of a licence (however described) authorising the cultivation of cannabis plants for the purposes of producing cannabis or cannabis resin for medicinal or related scientific purposes, or otherwise authorise such cultivation; (b) provide for the grant of a licence (however described) authorising the production of cannabis or cannabis resin for medicinal or related scientific purposes, or otherwise authorise such production; (c) prohibit an activity, or prevent a person from engaging in an activity, that is authorised under Chapter 2 or section 25A of this Act, or another provision of this Act so far as it relates to Chapter 2 or section 25A. (2) Subsection (1) does not apply to a law, or a provision of a law, prescribed by the regulations for the purposes of this subsection. (3) Regulations made for the purposes of subsection (2) may prescribe a law, or a provision of a law, in relation to its operation in prescribed circumstances. 9 Section 8A Repeal the section, substitute: Part 2—Fit and proper person requirements 8A Matters to be taken into account in deciding whether a natural person is a fit and proper person Without limiting the matters to which the Secretary may have regard in deciding whether a natural person is a fit and proper person to hold a licence, or to be associated with the holder of a licence, the Secretary may have regard to the following: (a) any conviction of the person for an offence against a law of the Commonwealth, a State or a Territory; (b) any civil penalty (however described) imposed upon the person under a law of the Commonwealth, a State or a Territory; (c) any revocation or suspension of a licence or permit (however described) held by the person 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) the connections and associations that the person has with other persons (including but not limited to the person's relatives); (e) the person's previous business experience; (f) the capacity of the person to comply with conditions of the licence; (g) whether the person has a sound and stable financial background or is in financial circumstances that may significantly limit the person's capacity to comply with his or her obligations under a licence; (h) whether the person is of good repute, having regard to matters going to their character, honesty and professional and personal integrity; (i) the person's history of compliance with this Act. Note: The Secretary must refuse to grant a licence to a person if the Secretary is not satisfied on reasonable grounds that the person and his or her business associates are fit and proper, and must revoke the licence if satisfied on reasonable grounds that they are not fit and proper. 8B Matters to be taken into account in deciding whether a body corporate is a fit and proper person Without limiting the matters to which the Secretary may have regard in deciding whether a body corporate is a fit and proper person to hold a licence, or to be associated with the holder of a licence, the Secretary must have regard to the following: (a) any conviction of the body corporate for an offence against a law of the Commonwealth, a State or a Territory; (b) any civil penalty (however described) imposed upon the body corporate 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) 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 connections and associations that the body corporate, and its directors and officers, have with other persons (including but not limited to relatives of such directors and officers); (f) 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; (g) whether the body corporate has a sound and stable financial background or is in financial circumstances that may significantly limit the capacity of the body corporate to comply with its obligations under a licence; (h) the capacity of the body corporate to meet the conditions of the licence; (i) whether the directors and officers of the body corporate are of good repute, having regard to matters going to their character, honesty and professional and personal integrity; (j) the body corporate's history of compliance with this Act. Note: The Secretary must refuse to grant a licence to a person if the Secretary is not satisfied on reasonable grounds that the person and his or her business associates are fit and proper, and must revoke the licence if satisfied on reasonable grounds that they are not fit and proper. 8C Part does not affect spent convictions provisions Nothing in this Part affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them). 10 Part II Repeal the Part, substitute: Chapter 2—Licensing the cultivation of cannabis plants and the production of cannabis etc. Part 1—Introduction 8D Simplified outline of this Chapter There are 2 types of cannabis licence. A medicinal cannabis licence may authorise: (a) the cultivation of cannabis plants for producing cannabis or cannabis resin for medicinal purposes and the obtaining of cannabis plants for that purpose; or (b) the production of cannabis or cannabis resin for medicinal purposes; or (c) all of the above; and activities related to such cultivation, obtaining or production. A cannabis research licence may authorise: (a) the cultivation of cannabis plants for producing cannabis or cannabis resin for research relating to medicinal cannabis and the obtaining of cannabis plants for that purpose; or (b) the production of cannabis or cannabis resin for research relating to medicinal cannabis; or (c) all of the above; and activities related to such cultivation, obtaining or production. Before a licence holder can cultivate cannabis plants, or produce cannabis or cannabis resin, the licence holder must obtain a cannabis permit. Permits deal with matters such as the types of cannabis plants that can be cultivated and the quantities of cannabis and cannabis resin that can be produced. Certain conditions are imposed on all cannabis licences, and the Secretary may impose additional conditions. Cannabis licences and cannabis permits can be varied or revoked in certain circumstances. There are offences and civil penalties relating to the cultivation and obtaining of cannabis plants and the production of cannabis and cannabis resin. Part 2—Licences and permits Division 1—Medicinal cannabis licences and permits 8E Person may apply for a medicinal cannabis licence (1) A person may apply to the Secretary for a licence (a medicinal cannabis licence) that authorises one or more of the following activities: (a) the cultivation of cannabis plants, in accordance with one or more medicinal cannabis permits, for the purpose of producing cannabis or cannabis resin for medicinal purposes and, if appropriate, the obtaining of cannabis plants for the purpose of such cultivation; (b) the production of cannabis or cannabis resin for medicinal purposes, in accordance with one or more medicinal cannabis permits; (c) activities relating to such obtaining, cultivation or production, including but not limited to the following (as applicable): (i) the supply of cannabis plants, cannabis or cannabis resin; (ii) the packaging, transport, storage, possession and control of cannabis plants, cannabis or cannabis resin; (iii) the disposal or destruction of cannabis plants, cannabis or cannabis resin. Note: A cannabis plant includes the seeds of a cannabis plant (see subsection 4(1)). (2) The application must be made in the form or manner approved in writing by the Secretary, and must: (a) contain the information (if any) prescribed by the regulations; and (b) contain the information (if any) specified in writing by the Secretary; and (c) be accompanied by the documents (if any) prescribed by the regulations; and (d) be accompanied by the documents (if any) specified in writing by the Secretary. Note: The Secretary may also require additional information and documents from the applicant at any time: see subsection 14J(1). (3) The application must be accompanied by the application fee (if any) prescribed by the regulations. (4) The application may be withdrawn at any time before a decision is made on the application, but the application fee is not refundable. 8F Secretary must make a decision on an application for a medicinal cannabis licence (1) If a person has made an application for a medicinal cannabis licence, the Secretary must decide whether to grant, or refuse to grant, the licence. (2) The Secretary may, subject to sections 8G and 8J, grant a medicinal cannabis licence if the Secretary considers it appropriate in all the circumstances to do so. (3) For the purposes of deciding whether to grant, or refuse to grant, a medicinal cannabis licence, the Secretary: (a) must have regard to the following: (i) the information and documents provided by the applicant; (ii) any advice, information or documents received in response to a request or requirement under section 14J, 14K or 14L including, in particular, any advice provided by an agency of a State or Territory in which any activities proposed to be authorised by the licence will take place; (iii) any other matter prescribed by the regulations; and (b) may have regard to any other matter relating to the conduct of activities authorised by the licence or the distribution, use and possession of cannabis plants cultivated or obtained, or cannabis or cannabis resin produced, under the licence; and (c) may have regard to any other matter the Secretary considers relevant; and (d) may require the applicant to provide access to land or premises at which activities proposed to be authorised by the licence will take place, for the purposes of inspecting the land or premises. 8G General circumstances in which Secretary must refuse to grant a medicinal cannabis licence (1) The Secretary must refuse to grant a medicinal cannabis licence if: (a) the Secretary is not satisfied on reasonable grounds that: (i) the applicant is a fit and proper person to hold the licence; and (ii) each of the applicant's relevant business associates for the application (see subsection (2)), whether in relation to a business relating to the medicinal cannabis licence, or in relation to any other business, is a fit and proper person to be associated with the holder of a medicinal cannabis licence; or (b) subject to section 8H—the Secretary is satisfied on reasonable grounds that: (i) the applicant; or (ii) if the applicant is a body corporate, any of the directors of the body corporate; has engaged in conduct that constitutes a serious offence during the 10 years immediately before the date of the application; or (c) the Secretary is satisfied on reasonable grounds that the grant of the licence would not be consistent with Australia's obligations under the Convention; or (d) the Secretary is not satisfied on reasonable grounds that the applicant will take all reasonable measures to ensure the physical security of cannabis plants, cannabis or cannabis resin: (i) in the applicant's possession or control; and (ii) obtained, cultivated or produced under, or purportedly under, the licence; or (e) the Secretary is not satisfied on reasonable grounds of the suitability of the location, facilities or proposed security arrangements at the land or premises where activities authorised by the licence will take place; or (f) the Secretary is satisfied on reasonable grounds that one or more circumstances exist that are prescribed by the regulations as circumstances in which a licence must not be granted; or (g) the application fee (if any) has not been paid; or (h) the applicant has not complied with a requirement under subsection 14J(1) (additional information) in relation to the application. Relevant business associate (2) A business associate of an applicant is a relevant business associate for the application if the Secretary considers it is reasonable, in the circumstances of the application, to take that business associate into account. 8H Exception in special circumstances Paragraph 8G(1)(b) does not prevent the Secretary from granting a medicinal cannabis licence if the Secretary is satisfied: (a) that the conduct referred to in that paragraph: (i) constitutes a serious offence solely because it involves the cultivation or obtaining of the cannabis plant, or the production or supply of cannabis or cannabis resin or of products containing cannabis or cannabis resin; and (ii) was fully disclosed in the application; and (b) that if the licence were granted, the applicant could comply with all the requirements of the licence and this Act. However, this section does not require the Secretary to grant the licence even if the Secretary is so satisfied. 8J Particular circumstances in which Secretary must refuse to grant a medicinal cannabis licence Licence authorising cultivation but not production (1) The Secretary must refuse to grant a medicinal cannabis licence that: (a) authorises the cultivation of cannabis plants (whether or not it also authorises the obtaining of cannabis plants); and (b) does not also authorise the production of cannabis or cannabis resin; if the Secretary is not satisfied on reasonable grounds that the cultivation of the cannabis plants is: (c) for the purposes of supply to the holder of a medicinal cannabis licence that authorises such production; or (d) for a purpose prescribed by the regulations. Licence authorising production (2) The Secretary must refuse to grant a medicinal cannabis licence that authorises the production of cannabis or cannabis resin (whether or not it also authorises the cultivation of cannabis plants) if the Secretary is not satisfied on reasonable grounds that: (a) the production of the cannabis or cannabis resin for medicinal purposes is for the purposes of supply to the holder of a licence under this Act that authorises: (i) the manufacture of one or more drugs that are medicinal cannabis products; or (ii) the manufacture of a drug for the purposes of research relating to medicinal cannabis products; or (b) the applicant holds a licence that authorises such manufacture; or (c) the production of the cannabis or cannabis resin for medicinal purposes is for a purpose prescribed by the regulations. 8K Secretary may impose conditions If the Secretary decides to grant a medicinal cannabis licence, the Secretary may impose conditions to which the licence is subject including, but not limited to, conditions relating to matters set out in section 10D. Note 1: For requirements for a notice of a decision to impose conditions on a medicinal cannabis licence, see section 15F. Note 2: Conditions are also specified in this Act (see sections 10E to 10K), and may also be prescribed by the regulations (see paragraph 10C(b)). 8L Notification of decision If the Secretary decides to grant a medicinal cannabis licence, the Secretary must, as soon as practicable: (a) notify the applicant for the licence, in writing, of the Secretary's decision; and (b) provide a copy of the licence, specifying the matters as mentioned in section 8M, to the applicant. Note: For requirements for a notice of a decision to refuse to grant a medicinal cannabis licence, see section 15F. 8M Matters to be specified in a medicinal cannabis licence A medicinal cannabis licence must specify the following: (a) the name of the licence holder; (b) the activities authorised by the licence, and the extent to which those activities are authorised only in accordance with one or more medicinal cannabis permits held by the licence holder; (c) the extent of the land on which, and the premises at which, the obtaining and cultivation of cannabis plants, and the production of cannabis or cannabis resin, as the case requires, is authorised by the licence in accordance with one or more medicinal cannabis permits; (d) the premises at which other activities relating to such obtaining, cultivation or production is authorised by the licence; (e) the persons authorised by the licence to engage in activities authorised by the licence; (f) the conditions (if any) imposed by the Secretary under section 8K; (g) the period for which the licence is in force; (h) that the Secretary may, in accordance with section 15, require the destruction of cannabis plants, cannabis or cannabis resin in the possession of, or under the control of, the licence holder. 8N Period in force of a medicinal cannabis licence A medicinal cannabis licence ceases to be in force: (a) at the end of the period for which it is expressed to be in force; or (b) if it is revoked earlier—when it is revoked. 8P Holder of a medicinal cannabis licence may apply for a medicinal cannabis permit (1) The holder of a medicinal cannabis licence may apply for a permit (a medicinal cannabis permit) in relation to activities that are authorised by the licence only in accordance with such a permit. (2) The application must be made in the form or manner approved in writing by the Secretary, and must: (a) contain the information (if any) prescribed by the regulations; and (b) contain the information (if any) specified in writing by the Secretary; and (c) be accompanied by the documents (if any) prescribed by the regulations; and (d) be accompanied by the documents (if any) specified in writing by the Secretary. Note: The Secretary may also require additional information and documents from the applicant at any time: see subsection 14J(1). (3) The application must be accompanied by the application fee (if any) prescribed by the regulations. (4) The application may be withdrawn at any time before a decision is made on the application, but the application fee is not refundable. 9 Secretary must make a decision on an application for a medicinal cannabis permit (1) If a person has made an application for a medicinal cannabis permit, the Secretary must decide whether to grant, or refuse to grant, the permit. (2) The Secretary may, subject to subsections (3) and (4), grant a medicinal cannabis permit if the Secretary considers it appropriate in all the circumstances to do so. (3) The Secretary may refuse to grant a medicinal cannabis permit if the Secretary is satisfied on reasonable grounds that the holder of the medicinal cannabis licence to which the permit relates has breached a condition of the licence. (4) The Secretary must refuse to grant a medicinal cannabis permit if: (a) the application fee (if any) has not been paid; or (b) the applicant has not complied with a requirement under subsection 14J(1) (additional information) in relation to the application. 9A Notification of decision If the Secretary decides to grant a medicinal cannabis permit that relates to a medicinal cannabis licence, the Secretary must, as soon as practicable: (a) notify the licence holder, in writing, of the Secretary's decision; and (b) provide a copy of the permit, specifying the matters as mentioned in section 9B, to the licence holder. Note: For requirements for a notice of a decision to refuse to grant a medicinal cannabis permit, see section 15F. 9B Matters to be specified in a medicinal cannabis permit Medicinal cannabis permits—cultivation (1) Without limiting the matters that the Secretary may specify in a medicinal cannabis permit that relates to a licence that authorises the cultivation of cannabis plants, the Secretary may specify one or more of the following that are authorised by the licence in accordance with the permit: (a) the types and strains of cannabis plants that may be cultivated; (b) the maximum size of the cannabis crop that may be cultivated; (c) the maximum number of cannabis plants that, in the opinion of the Secretary, having regard to Australia's obligations under the Convention, it is necessary for the licence holder to have in the holder's possession or control at any time for the normal conduct of business; (d) the period during which cannabis plants may be cultivated; (e) the period for which the permit is in force; (f) any matter prescribed by the regulations. Note 1: Section 10J provides that (in general) it is a condition of a medicinal cannabis licence that certain contracts are in force while a medicinal cannabis permit is in force. Note 2: A cannabis plant includes the seeds of a cannabis plant (see subsection 4(1)). Medicinal cannabis permits—production (2) Without limiting the matters that the Secretary may specify in a medicinal cannabis permit that relates to a licence that authorises the production of cannabis or cannabis resin, the Secretary may specify one or more of the following that are authorised by the licence in accordance with the permit: (a) the maximum quantity of cannabis or cannabis resin that may be produced; (b) the maximum quantity of cannabis or cannabis resin that, in the opinion of the Secretary, having regard to Australia's obligations under the Convention, it is necessary for the licence holder to have in the holder's possession or control at any time for the normal conduct of business; (c) the period during which the cannabis or cannabis resin may be produced; (d) the period for which the permit is in force; (e) any matter prescribed by the regulations. Note: Section 10J provides that (in general) it is a condition of a medicinal cannabis licence that certain contracts are in force while a medicinal cannabis permit is in force. 9C Period in force of a medicinal cannabis permit A medicinal cannabis permit ceases to be in force: (a) at the end of the period for which it is expressed to be in force; or (b) if it is revoked or taken to be revoked earlier—when it is revoked or taken to be revoked. Note: A medicinal cannabis permit is taken to be revoked if the medicinal cannabis licence to which the permit relates is revoked: see subsection 10P(4). Division 2—Cannabis research licences and permits 9D Person may apply for a cannabis research licence (1) A person may apply to the Secretary for a licence (a cannabis research licence) that authorises one or more of the following activities: (a) the cultivation of cannabis plants, in accordance with one or more cannabis research permits, for the purpose of producing cannabis or cannabis resin for research relating to medicinal cannabis and, if appropriate, the obtaining of cannabis plants for the purpose of such cultivation; (b) the production of cannabis or cannabis resin for research relating to medicinal cannabis, in accordance with one or more cannabis research permits; (c) activities relating to such cultivation, obtaining or production, including but not limited to the following (as applicable): (i) the packaging, transport, storage, possession and control of cannabis plants, cannabis or cannabis resin; (ii) the disposal or destruction of cannabis plants, cannabis or cannabis resin. Note: A cannabis plant includes the seeds of a cannabis plant (see subsection 4(1)). (2) The application must be made in the form or manner approved in writing by the Secretary, and must: (a) contain the information (if any) prescribed by the regulations; and (b) contain the information (if any) specified in writing by the Secretary; and (c) be accompanied by the documents (if any) prescribed by the regulations; and (d) be accompanied by the documents (if any) specified in writing by the Secretary. Note: The Secretary may also require additional information and documents from the applicant at any time: see subsection 14J(1). (3) The application must be accompanied by the application fee (if any) prescribed by the regulations. (4) The application may be withdrawn at any time before a decision is made on the application, but the application fee is not refundable. 9E Secretary must make a decision on an application for a cannabis research licence (1) If a person has made an application for a cannabis research licence, the Secretary must decide whether to grant, or refuse to grant, the licence. (2) The Secretary may, subject to sections 9F and 9H, grant the cannabis research licence if the Secretary considers it appropriate in all the circumstances to do so. (3) For the purposes of deciding whether to grant, or refuse to grant, a cannabis research licence, the Secretary: (a) must have regard to the following: (i) the information and documents provided by the applicant; (ii) any advice, information or documents received in response to a request or requirement under section 14J, 14K or 14L including, in particular, any advice provided by an agency of a State or Territory in which any activities proposed to be authorised by the licence will take place; (iii) any other matter prescribed by the regulations; and (b) may have regard to any other matter relating to the distribution, use, possession and control of cannabis plants cultivated or obtained, or cannabis or cannabis resin produced under the licence; and (c) may have regard to any other matter the Secretary considers relevant; and (d) may require the applicant to provide access to land or premises at which activities proposed to be authorised by the licence will take place, for the purposes of inspecting the land or premises. 9F General circumstances in which Secretary must refuse to grant a cannabis research licence (1) The Secretary must refuse to grant a cannabis research licence if: (a) the Secretary is not satisfied on reasonable grounds that: (i) the applicant is a fit and proper person to hold the licence; and (ii) each of the applicant's relevant business associates for the application (see subsection (2)), whether in relation to a business relating to the cannabis research licence, or in relation to any other business, is a fit and proper person to be associated with the holder of a cannabis research licence; or (b) subject to section 9G—the Secretary is satisfied on reasonable grounds that: (i) the applicant; or (ii) if the applicant is a body corporate, any of the directors of the body corporate; has engaged in conduct that constitutes a serious offence during the 10 years immediately before the date of the application; or (c) the Secretary is satisfied on reasonable grounds that the grant of the licence would not be consistent with Australia's obligations under the Convention; or (d) the Secretary is not satisfied on reasonable grounds that the applicant will take all reasonable measures to ensure the physical security of cannabis plants, cannabis or cannabis resin: (i) in the applicant's possession or control; and (ii) obtained, cultivated or produced under, or purportedly under, the licence; or (e) the Secretary is not satisfied on reasonable grounds of the suitability of the location, facilities or proposed security arrangements at the land or premises where activities authorised by the licence will take place; or (f) the Secretary is satisfied on reasonable grounds that one or more circumstances exist that are prescribed by the regulations as circumstances in which a licence must not be granted; or (g) the application fee (if any) has not been paid; or (h) the applicant has not complied with a requirement under subsection 14J(1) (additional information) in relation to the application. Relevant business associate (2) A business associate of an applicant is a relevant business associate for the application if the Secretary considers it is reasonable, in the circumstances of the application, to take that business associate into account. 9G Exception in special circumstances Paragraph 9F(1)(b) does not prevent the Secretary from granting a cannabis research licence if the Secretary is satisfied that: (a) the conduct referred to in that paragraph: (i) constitutes a serious offence solely because it involves the cultivation or obtaining of the cannabis plant, or the production or supply of cannabis or cannabis resin or of products containing cannabis or cannabis resin; and (ii) was fully disclosed in the application; and (b) if the licence were granted, the applicant could comply with all the requirements of the licence and this Act. However, this section does not require the Secretary to grant the licence even if the Secretary is so satisfied. 9H Particular circumstances in which Secretary must refuse to grant cannabis research licence The Secretary must refuse to grant a cannabis research licence if the Secretary is not satisfied on reasonable grounds of the following: (a) if the licence will authorise the cultivation of cannabis plants—the cultivation so authorised is for the purposes of research relating to medicinal cannabis; (b) if the licence will authorise the production of cannabis or cannabis resin—the production of cannabis or cannabis resin authorised by the licence is: (i) for the purposes of research relating to medicinal cannabis by the applicant; or (ii) for the purposes of research relating to medicinal cannabis products; (c) the applicant: (i) has the appropriate financial resources, other resources and expertise that are necessary to carry out such research; or (ii) is included in a class of persons prescribed by the regulations. 9J Secretary may impose conditions If the Secretary decides to grant a cannabis research licence, the Secretary may impose conditions to which the licence is subject including, but not limited to, conditions set out in section 10D. Note 1: For requirements for a notice of a decision to impose conditions on a cannabis research licence, see section 15F. Note 2: Conditions are also specified in this Act (see sections 10E to 10K), and may also be prescribed by the regulations (see paragraph 10C(b)). 9K Notification of decision If the Secretary decides to grant a cannabis research licence, the Secretary must, as soon as practicable: (a) notify the applicant for the licence, in writing, of the Secretary's decision; and (b) provide a copy of the licence, specifying the matters as mentioned in section 9L, to the applicant. Note: For requirements for a notice of a decision to refuse to grant a cannabis research licence, see section 15F. 9L Matters to be specified in a cannabis research licence A cannabis research licence must specify the following: (a) the name of the licence holder; (b) the activities authorised by the licence, and the extent to which those activities are authorised only in accordance with one or more cannabis research permits held by the licence holder; (c) the extent of the land on which, and the premises at which, the obtaining and cultivation of cannabis plants, and the production of cannabis or cannabis resin, as the case requires, is authorised by the licence in accordance with a cannabis research permit; (d) the premises at which other activities relating to such obtaining, cultivation or production is authorised by the licence; (e) the persons authorised by the licence to engage in activities authorised by the licence; (f) the conditions (if any) imposed by the Secretary under section 9J; (g) the period for which the licence is in force; (h) that the Secretary may, in accordance with section 15, require the destruction of cannabis plants, cannabis or cannabis resin in the licence holder's possession or control. 9M Period in force of a cannabis research licence A cannabis research licence ceases to be in force: (a) at the end of the period for which it is expressed to be in force; or (b) if it is revoked earlier—when it is revoked. 9N Holder of a cannabis research licence may apply for a cannabis research permit (1) The holder of a cannabis research licence may apply for a permit (a cannabis research permit) in relation to activities that are authorised by the licence only in accordance with such a permit. (2) The application must be made in the form or manner approved in writing by the Secretary, and must: (a) contain the information (if any) prescribed by the regulations; and (b) contain the information (if any) specified in writing by the Secretary; and (c) be accompanied by the documents (if any) prescribed by the regulations; and (d) be accompanied by the documents (if any) specified in writing by the Secretary. Note: The Secretary may also require additional information and documents from the applicant at any time: see subsection 14J(1). (3) The application must be accompanied by the application fee (if any) prescribed by the regulations. (4) The application may be withdrawn at any time before a decision is made on the application, but the application fee is not refundable. 9P Secretary must make a decision on an application for a cannabis research permit (1) If a person has made an application for a cannabis research permit, the Secretary must decide whether to grant, or refuse to grant, the permit. (2) The Secretary may, subject to subsections (3) and (4), grant a cannabis research permit if the Secretary considers it appropriate in all the circumstances to do so. (3) The Secretary may refuse to grant a cannabis research permit if the Secretary is satisfied on reasonable grounds that the holder of the cannabis research licence to which the permit relates has breached a condition of the licence. (4) The Secretary must refuse to grant a cannabis research permit if: (a) the application fee (if any) has not been paid; or (b) the applicant has not complied with a requirement under subsection 14J(1) (additional information) in relation to the application. 10 Notification of decision If the Secretary decides to grant a cannabis research permit that relates to a cannabis research licence, the Secretary must, as soon as practicable: (a) notify the licence holder, in writing, of the Secretary's decision; and (b) provide a copy of the permit, specifying the matters as mentioned in section 10A, to the licence holder. Note: For requirements for a notice of a decision to refuse to grant a cannabis research permit, see section 15F. 10A Matters to be specified in a cannabis research permit Cannabis research permits—cultivation (1) Without limiting the matters that the Secretary may specify in a cannabis research permit that relates to a licence that authorises the cultivation of cannabis plants, the Secretary may specify one or more of the following that are authorised by the licence in accordance with the permit: (a) the types and strains of cannabis plants that may be cultivated; (b) the maximum size of the cannabis crop that may be cultivated; (c) the maximum number of cannabis plants that, in the opinion of the Secretary, having regard to Australia's obligations under the Convention, it is necessary for the licence holder to have in the holder's possession or control at any time for conducting the research authorised by the licence; (d) the period during which cannabis plants may be cultivated; (e) the period for which the permit is in force; (f) any matters prescribed by the regulations. Note: A cannabis plant includes the seeds of a cannabis plant (see subsection 4(1)). Cannabis research permits—production (2) Without limiting the matters that the Secretary may specify in a cannabis research permit that relates to a licence that authorises the production of cannabis or cannabis resin, the Secretary may specify one or more of the following that are authorised by the licence in accordance with the permit: (a) the maximum quantity of cannabis or cannabis resin that may be produced; (b) the maximum quantity of cannabis or cannabis resin that, in the opinion of the Secretary, having regard to Australia's obligations under the Convention, 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 may be produced; (d) the period for which the permit is in force; (e) any matters prescribed by the regulations. 10B Period in force of a cannabis research permit A cannabis research permit ceases to be in force: (a) at the end of the period for which it is expressed to be in force; or (b) if it is revoked or taken to be revoked earlier—when it is revoked or taken to be revoked. Note: A cannabis research permit is taken to be revoked if the cannabis research licence to which the permit relates is revoked: see subsection 10P(4). Division 3—Conditions of cannabis licences 10C Cannabis licence is subject to conditions A cannabis licence is subject to the following conditions: (a) the conditions set out in sections 10E to 10K; (b) the conditions (if any) prescribed by the regulations; (c) the conditions (if any) imposed by the Secretary (see sections 8K, 9J, 10D and 10M). 10D Conditions that may be prescribed or imposed (1) The conditions of a cannabis licence that may be prescribed or imposed may relate to, but are not limited to, the following: (a) matters relating to the activities authorised by the licence, including activities authorised in accordance with a permit; (b) the supply, delivery, dealing in any way with, transportation and disposal of cannabis plants cultivated or obtained, or cannabis or cannabis resin produced, under the licence in accordance with a permit; (c) the use of names or symbols that may suggest or imply a particular effect upon humans of cannabis or cannabis resin, but not so as to prevent the specification of factual material; (d) waste disposal; (e) the destruction of cannabis plants, parts of cannabis plants, cannabis or cannabis resin, including the specification of the circumstances in which: (i) destruction must not occur without the Secretary's permission; or (ii) destruction must occur; (f) documentation and record‑keeping in respect of activities to which the licence relates; (g) facilities and containment in respect of the cultivation or production authorised by the licence, including requirements relating to the following: (i) the security of premises; (ii) the certification of premises or facilities to specified containment levels; (h) the safety, security and surveillance of land and premises; (i) access to land and premises on which activities authorised by the licence are, are to be, or have been, undertaken; (j) measures to manage risks posed to the health and safety of people, or to the environment; (k) data collection, including studies to be conducted; (l) information that is to be provided, whether on request by the Secretary, on a regular basis or on the occurrence of a particular event, and the times at which, or periods within which, such information is to be provided; (m) the taking of samples of any thing to which the licence relates and the removal and testing of such samples; (n) auditing and reporting; (o) actions to be taken in case of loss, theft, spoilage or destruction (however occurring) of cannabis plants cultivated or obtained, or cannabis or cannabis resin produced, under (or purportedly under) the licence; (p) compliance with the following (however described): (i) a code of practice; (ii) a technical or procedural guideline (however described); (iii) a prescribed quality standard; (q) contingency planning; (r) matters relating to the employment of staff or the engagement of contractors; (s) advertising to the public by the licence holder in relation to cannabis plants, cannabis or cannabis resin. (2) Cannabis licence conditions may include conditions requiring the licence holder to be adequately insured against any loss, damage, or injury that may be caused to human health, property or the environment by activities undertaken under (or purportedly under) the licence. 10E Condition that cannabis licence holder inform people of obligations (1) It is a condition of a cannabis licence that the licence holder inform any person authorised by the licence: (a) to engage in the obtaining or cultivation of cannabis plants, or activities related to such obtaining or cultivation; or (b) to engage in the production of cannabis or cannabis resin, or activities related to such production; of the following: (c) each condition that is relevant to that person, including each variation or revocation of such a condition; (d) the revocation of the licence and of any permit that relates to the licence and is relevant to the person; (e) the giving of one or more directions in relation to the licence under Part 3 of Chapter 5. (2) Requirements in relation to the manner in which information is provided under subsection (1) may be: (a) prescribed by the regulations; or (b) specified by the Secretary. (3) A reference in subsection (1) to a licence holder or a person authorised under a cannabis licence is, in the case of revocation of the licence, taken to be a reference to a person who was the licence holder, or was so authorised, immediately before that revocation. 10F Condition that cannabis licence holder employ or engage suitable staff (1) It is a condition of a cannabis licence that the licence holder take all reasonable steps not to employ or engage a person to carry out activities authorised by the licence if: (a) the person is aged under 18 years; or (b) the person has been convicted of a serious offence during the period of 5 years before the employment or engagement; or (c) the person is taken not to be suitable to carry out activities authorised by a cannabis licence under regulations made for the purposes of subsection (2); or (d) the person is included in a class of persons prescribed by the regulations for the purposes of this paragraph. (2) The regulations may prescribe circumstances in which a person is taken not to be suitable to carry out activities authorised by a cannabis licence, including but not limited to circumstances relating to the following: (a) a person's criminal record; (b) a person's employment history. 10G Condition that certain activities are undertaken in accordance with a cannabis permit Medicinal cannabis licence (1) It is a condition of a medicinal cannabis licence that the licence holder, and other persons authorised by the licence to obtain or cultivate cannabis plants, or to produce cannabis or cannabis resin, do so in accordance with a medicinal cannabis permit. Cannabis research licence (2) It is a condition of a cannabis research licence that the licence holder, and other persons authorised by the licence to obtain or cultivate cannabis plants, or to produce cannabis or cannabis resin, do so in accordance with a cannabis research permit. 10H Condition about monitoring and inspection It is a condition of a cannabis licence that, if a person is authorised by the licence: (a) to obtain or cultivate cannabis plants or to produce cannabis or cannabis resin; or (b) to engage in activities related to such obtaining, cultivation or production; the person allow the Secretary, or a person authorised by the Secretary, to: (c) enter land or premises at which the person is present and where the obtaining, cultivation, production or activity is being undertaken, for the purposes of the following: (i) inspecting or monitoring the obtaining, cultivation, production or activity; (ii) checking whether the obtaining, cultivation, production or activity is being carried out as authorised by the licence in accordance with a cannabis permit, and whether licence conditions are being complied with; and (d) take samples of any thing at such land or premises and remove and test such samples. 10J Condition that medicinal cannabis licence holder be a party to certain contracts Licence authorising cultivation but not production (1) If, at a particular time: (a) a medicinal cannabis licence authorises the obtaining or cultivation of cannabis plants for the purposes of producing cannabis or cannabis resin, but does not also authorise the production of cannabis or cannabis resin; and (b) a medicinal cannabis permit that relates to such cultivation is in force; it is a condition of the licence that a contract that deals with matters prescribed by the regulations is in existence between: (c) the holder of the medicinal cannabis licence; and (d) the holder of another medicinal cannabis licence that authorises the production of cannabis or cannabis resin. Licence authorising production (2) If, at a particular time: (a) a medicinal cannabis licence authorises the production of cannabis or cannabis resin; and (b) a medicinal cannabis permit that relates to such production is in force; it is a condition of the licence that: (c) a contract that deals with matters prescribed by the regulations is in existence between the holder of the medicinal cannabis licence and the holder of a licence under this Act that authorises: (i) the manufacture of one or more drugs that are medicinal cannabis products; or (ii) the manufacture of a drug for the purposes of research in relation to medicinal cannabis products; or (d) the holder of the medicinal cannabis licence holds a licence that authorises such manufacture. (3) A contract of a kind referred to in subsection (1) or (2) is not required to be in existence: (a) in the circumstances (if any) prescribed by the regulations; or (b) if the Secretary determines in a particular case that such a contract is not required to be in existence. 10K Condition that licence holder notify the Secretary of certain matters It is a condition of a cannabis licence that the licence holder notify the Secretary as soon as reasonably practicable after any of the following matters comes to the attention of the licence holder: (a) a matter that may affect whether the licence holder is a fit and proper person to hold the licence, or whether a business associate of the licence holder (in relation to a business relating to the licence or in relation to any other business) is a fit and proper person to be associated with the holder of such a licence; (b) a breach of the licence; (c) any other matter that may require or permit the Secretary to revoke the licence or a permit to which the licence relates; (d) any matter prescribed by the regulations. Note: Section 24B deals with the privilege against self‑incrimination. 10L Sections 10E to 10K do not limit conditions that may be imposed or prescribed Sections 10E to 10K do not limit the conditions that may be imposed by the Secretary or prescribed by the regulations. Division 4—Variation and revocation of cannabis licences and cannabis permits 10M Variation of cannabis licences and cannabis permits (1) The Secretary may vary a cannabis licence, or a cannabis permit that relates to a cannabis licence, by notice in writing given to the licence holder: (a) at any time, on the Secretary's own initiative; or (b) on application by the licence holder. Note: For requirements for a notice of a decision under paragraph (1)(a) to vary a cannabis licence or cannabis permit, see section 15F. (2) The Secretary may vary a cannabis licence or a cannabis permit if the Secretary considers it appropriate in all the circumstances to do so. (3) Despite subsection (2), the Secretary must not vary a cannabis licence or a cannabis permit if: (a) the Secretary is satisfied on reasonable grounds that the variation of the licence or permit would not be consistent with Australia's obligations under the Convention; or (b) the Secretary is satisfied on reasonable grounds that one or more circumstances exist that are prescribed by the regulations as circumstances in which a licence or permit must not be varied; or (c) if an application was made for the variation: (i) the application fee (if any) has not been paid; or (ii) the applicant has not complied with a requirement under subsection 14J(1) (additional information) in relation to the application. (4) Without limiting subsection (1), the Secretary may: (a) vary a cannabis licence to impose licence conditions or additional licence conditions, or (b) vary a cannabis licence to remove or vary licence conditions that were imposed by the Secretary under section 8K or 9J or paragraph (a) of this subsection; or (c) vary a cannabis licence to extend, modify or reduce the activities authorised by the licence or the persons authorised by the licence to engage in activities authorised by the licence. (5) If the Secretary decides to vary a cannabis licence or a cannabis permit to which the licence relates, the Secretary must give the licence or permit as varied to the licence holder. (6) A variation of a cannabis licence or a cannabis permit takes effect on the day specified in the notice under subsection (1). 10N Applications for variation of cannabis licences and permits (1) An application for a variation of a cannabis licence or a cannabis permit must be in writing, and must: (a) contain the information (if any) prescribed by the regulations