Division 2Conditions of manufacture licences

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 Chapter 1—Preliminary ## Part 1—General provisions #### 1 Short title This Act may be cited as the Narcotic Drugs Act 1967. #### 2 Commencement This Act shall come into operation on a date to be fixed by Proclamation, which shall not be a date earlier than the date on which the Convention comes into force in respect of the Commonwealth. #### 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. #### 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, the production of cannabis and cannabis resin, the manufacture of cannabis drugs, and activities relating to such cultivation, production and manufacture. Cultivation and production under the scheme may be undertaken for medicinal or scientific purposes whereas the manufacture of cannabis drugs may be undertaken for a permitted supply. A separate licensing and permit scheme regulates the manufacture of narcotic 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. #### 4 Interpretation (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 drug means: (a) cannabis; or (b) cannabis resin; or (c) extracts of cannabis; or (d) tinctures of cannabis; or (e) another drug that includes, or is from, any part of the cannabis plant. > cannabis plant has the same meaning as in the Convention. > cannabis resin has the same meaning as in the Convention. > charge means charge imposed by the Narcotic Drugs (Licence Charges) Act 2016. > 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 the following: (a) any substance prescribed by the regulations for the purposes of this paragraph; (b) any substance prescribed by the regulations under section 8 of this Act. > fit and proper person: see sections 8A and 8B. > guidelines means guidelines issued by the Minister under section 26C. > 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 Review Tribunal; or (c) a senior member or general member of the Administrative Review 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. > law enforcement agency means the following: (a) a body, agency or organisation that is responsible for, or deals with, law enforcement, criminal intelligence, criminal investigation, fraud or security intelligence in, or in a part of, Australia; (b) a body, agency or organisation prescribed by the regulations. > licence means: (a) a manufacture licence; or (b) 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). > narcotic drug means a drug other than a cannabis drug. > 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: (a) a manufacture permit; or (b) a medicinal cannabis permit. > permitted supply means: (a) the supply of a cannabis drug for use in a clinical trial that is, or is likely to be, approved under the Therapeutic Goods Act 1989 or notified to the Secretary under that Act; or (b) the supply of a cannabis drug in accordance with an approval or authority under that Act; or (c) the supply of a cannabis drug for use in medical or scientific research where that research: (i) is not a clinical trial of a kind referred to in paragraph (a); and (ii) does not involve the drug being administered to humans; or (d) the supply of a cannabis drug for use as a reference standard for medical or scientific testing purposes; or (e) the supply of a cannabis drug in circumstances prescribed by the regulations. > premises includes the following: (a) a structure or building; (b) a vehicle, vessel or aircraft; (c) an area of land or any other 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 and Family Court of Australia (Division 2); 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. > sensitive law enforcement information means information the disclosure of which is reasonably likely to prejudice Australia’s law enforcement interests, including Australia’s interests in the following: (a) avoiding disruption to national and international efforts relating to law enforcement, criminal intelligence, criminal investigation, foreign intelligence, security intelligence or the integrity of law enforcement agencies; (b) protecting the technologies and methods used to collect, analyse, secure or otherwise deal with, criminal intelligence, foreign intelligence, security intelligence or intelligence relating to the integrity of law enforcement agencies; (c) the protection and safety of: (i) informants or witnesses, or persons associated with informants or witnesses; or (ii) persons involved in the protection or safety of informants or witnesses; (d) ensuring that intelligence and law enforcement agencies are not discouraged from giving information to a nation’s government and government agencies. > 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. > standards means standards issued by the Minister under section 26B. > 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. (2) For the purposes of this Act, the manufacturing of a drug consists of the carrying out of any process by which the drug may be obtained, and includes the refining of a drug and the transformation of one drug into another drug, but does not include the separation of opium, coca leaves, cannabis or cannabis resin from the plants from which it is or they are obtained. #### 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 Inconsistency with State and Territory laws This Act, regulations under this Act and directions given under this Act do not apply to the exclusion of any law of a State or Territory or any regulation in force under an Act except in so far as that law or that regulation is inconsistent with an express provision of this Act, those regulations or those directions. #### 7A Interaction with State and Territory laws (1) Despite section 7, Chapter 2 of this Act, and other provisions of this Act so far as they relate to that Chapter, 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 (whether expressly or impliedly) 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 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 scientific purposes, or otherwise authorise such production; (c) prohibit an activity, or prevent a person from engaging in an activity, that: (i) is authorised under that Chapter or another provision of this Act so far as it relates to that Chapter; and (ii) is, or is related to, the cultivation of cannabis plants or the production of cannabis or cannabis resin. (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. #### 8 Provisional application of Act to substances Where the Commission on Narcotic Drugs of the Economic and Social Council of the United Nations decides, in accordance with paragraph 3 of Article 3 of the Convention, that the Parties to the Convention shall apply provisionally to a substance all measures of control applicable to drugs in Schedule I annexed to the Convention, the regulations may provide that the substance is a drug for the purposes of this Act. ## 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 may 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 Act does not affect spent conviction provisions Nothing in this Act 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). Chapter 2—Medicinal cannabis licences and permits ## Part 1—Introduction #### 8D Simplified outline of this Chapter This Chapter deals with medicinal cannabis licences and medicinal cannabis permits. A medicinal cannabis licence may authorise one or more of the following activities: (a) the cultivation of cannabis plants for the purpose of producing cannabis or cannabis resin for medicinal or scientific 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 or scientific purposes; (c) the manufacture of a cannabis drug for one or more permitted supplies; (d) activities relating to such obtaining, cultivation, production or manufacture. Before a licence holder can engage in any such activities, the licence holder must obtain a medicinal cannabis permit. Medicinal cannabis permits specify matters relating to the activities that are authorised by the licence. Certain conditions are imposed on all medicinal cannabis licences, and the Secretary may also impose additional conditions. Medicinal cannabis licences and permits can be varied or revoked in certain circumstances. There are offences and civil penalties relating to the cultivation and obtaining of cannabis plants, the production of cannabis and cannabis resin and the manufacture of cannabis drugs. #### 8DA Purpose of this Chapter A purpose of this Chapter is to enable the following activities to be undertaken in order to ensure that medicinal cannabis products are available to patients in Australia for therapeutic purposes: (a) the cultivation and obtaining of cannabis plants for the purposes of producing cannabis or cannabis resin for medicinal or scientific purposes; (b) the production of cannabis or cannabis resin for medicinal or scientific purposes; (c) the manufacture of a cannabis drug for a permitted supply. ## 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 or scientific 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 or scientific purposes, in accordance with one or more medicinal cannabis permits; (c) the manufacture of a cannabis drug for one or more permitted supplies, in accordance with one or more medicinal cannabis permits; (d) activities relating to such obtaining, cultivation, production or manufacture, including but not limited to the following (as applicable): (i) the supply of cannabis plants or a cannabis drug; (ii) the packaging, transport, storage, possession and control of cannabis plants or a cannabis drug; (iii) the taking of samples from cannabis plants or a cannabis drug and the testing of such samples; (iv) the disposal or destruction of cannabis plants or a cannabis drug. (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: (i) cannabis plants cultivated or obtained under the licence; or (ii) cannabis or cannabis resin produced under the licence; or (iii) a cannabis drug manufactured 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 premises at which activities proposed to be authorised by the licence will take place, for the purposes of inspecting the premises. > Note: The Secretary must have regard to any applicable guidelines (see subsection 26C(2)). #### 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 or cannabis drugs that: (i) are in the applicant’s possession or control; and (ii) are obtained, cultivated, produced or manufactured 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 premises where activities authorised by the licence will take place; or (ea) the Secretary is not satisfied on reasonable grounds that applicable standards have been or will be met, as the case requires; 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), or any other fee that has become payable, has not been paid; or (ga) the Secretary is satisfied on reasonable grounds that the application for the licence contains information, or information has been given by the applicant in relation to the application, that: (i) is false or misleading in a material particular; or (ii) omits any matter or thing without which the application is misleading in a material respect; 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 that authorises the manufacture of a cannabis drug The Secretary must refuse to grant a medicinal cannabis licence that authorises the manufacture of a cannabis drug unless the Secretary is satisfied on reasonable grounds that the drug will be manufactured for a permitted supply. #### 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) for each of the following activities that are authorised by the licence, the premises at which the activity is authorised by the licence in accordance with one or more medicinal cannabis permits: (i) the obtaining and cultivation of cannabis plants; (ii) the production of cannabis or cannabis resin; (iii) the manufacture of a cannabis drug; (d) the premises at which other activities relating to such obtaining, cultivation, production or manufacture is authorised by the licence; (da) if the licence authorises the cultivation of cannabis plants—the extent of the land on which the cultivation of cannabis plants is authorised by the licence in accordance with one or more medicinal cannabis permits; (e) the persons prescribed by the regulations as the persons who are authorised by the licence to engage in the activities authorised by the licence; (f) the conditions (if any) imposed by the Secretary under section 8K; (g) the day on which the licence comes into force; (h) if the licence is to be in force for a specified period—that period; (i) that the Secretary may, in accordance with section 15, require the destruction of any of the following that are in the possession of, or under the control of, the licence holder: (i) cannabis plants; (ii) a cannabis drug; (iii) a narcotic preparation that contains such a drug; (j) if the licence authorises the manufacture of a cannabis drug for one or more permitted supplies—those permitted supplies. #### 8N Period for which a medicinal cannabis licence is in force (1) If a medicinal cannabis licence is revoked under subsection 10P(1) or (2), the licence ceases to be in force on the day specified in the notice given under that subsection revoking the licence. (2) If: (a) a medicinal cannabis licence is surrendered in accordance with regulations made for the purposes of section 11A; and (b) as a result of that surrender, the licence is to cease to be in force on a particular day, or at a particular time, under those regulations; the licence ceases to be in force on that day, or at that time, unless it ceases to be in force under subsection (1) of this section on an earlier day. (3) If a medicinal cannabis licence specifies a period during which the licence is to remain in force, the licence ceases to be in force at the end of that period unless it ceases to be in force under subsection (1) or (2) on an earlier day or at an earlier time. #### 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 (aa) the Secretary is not satisfied on reasonable grounds that applicable standards have been or will be met, as the case requires; or (ab) the Secretary is satisfied on reasonable grounds that one or more circumstances exist that are prescribed by the regulations as circumstances in which a permit must not be granted; or (ac) the Secretary is satisfied on reasonable grounds that the application for the permit contains information, or information has been given by the applicant in relation to the application, that: (i) is false or misleading in a material particular; or (ii) omits any matter or thing without which the application is misleading in a material respect; or (b) the applicant has not complied with a requirement under subsection 14J(1) (additional information) in relation to the application; or (c) if the application for the permit relates to a medicinal cannabis licence that authorises the cultivation of cannabis plants but does not authorise the production of cannabis or cannabis resin—the Secretary is not satisfied on reasonable grounds that the cultivation of the cannabis plants is: (i) for the purposes of supply to the holder of a medicinal cannabis licence that authorises such production; or (ii) for a purpose prescribed by the regulations; or (d) if the application for the permit relates to a medicinal cannabis licence that authorises the production of cannabis or cannabis resin but does not authorise the manufacture of a cannabis drug—the Secretary is not satisfied on reasonable grounds that the production of the cannabis or cannabis resin is: (i) for the purposes of supply to another holder of a medicinal cannabis licence that authorises such manufacture; or (ii) for a purpose prescribed by the regulations. > Note: The Secretary must have regard to any applicable guidelines (see subsection 26C(2)). (5) For the purposes of deciding whether to grant, or refuse to grant, a medicinal cannabis permit, the Secretary may require the applicant to provide access to premises at which activities authorised by the medicinal cannabis licence to which the permit relates will take place, for the purposes of inspecting the premises. #### 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 medicinal cannabis 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 day on which the permit comes into force; (ea) if the permit is to be in force for a specified period—that period; (f) 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. Medicinal cannabis permits—production (2) Without limiting the matters that the Secretary may specify in a medicinal cannabis permit that relates to a medicinal cannabis 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 day on which the permit comes into force; (da) if the permit is to be in force for a specified period—that period; (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. Medicinal cannabis permits—manufacture (3) Without limiting the matters that the Secretary may specify in a medicinal cannabis permit that relates to a medicinal cannabis licence that authorises the manufacture of a cannabis drug, 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 the cannabis drug that may be manufactured at premises specified in the permit; (b) the maximum quantity of the cannabis drug that, in the opinion of the Secretary, having regard to prevailing market conditions, 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 drug may be manufactured; (d) the day on which the permit comes into force; (e) if the permit is to be in force for a specified period—that period; (f) any matter prescribed by the regulations. #### 9C Period for which a medicinal cannabis permit is in force (1) If a medicinal cannabis permit is revoked under subsection 10P(2), the permit ceases to be in force on the day specified in the notice given under that subsection revoking the permit. (2) If a medicinal cannabis permit is taken to be revoked under subsection 10P(4), the permit ceases to be in force at the time referred to in that subsection. (3) If: (a) a medicinal cannabis permit is surrendered in accordance with regulations made for the purposes of section 11A; and (b) as a result of that surrender, the permit is to cease to be in force on a particular day, or at a particular time, under those regulations; the permit ceases to be in force on that day, or at that time, unless it ceases to be in force under subsection (1) or (2) of this section on an earlier day or at an earlier time. (4) If a medicinal cannabis permit specifies a period during which the permit is to remain in force, the permit ceases to be in force at the end of that period unless it ceases to be in force under subsection (1), (2) or (3) on an earlier day or at an earlier time. ### Division 3—Conditions of medicinal cannabis licences #### 10C Medicinal cannabis licence is subject to conditions A medicinal 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, 10D and 10M). #### 10D Conditions that may be prescribed or imposed (1) The conditions of a medicinal 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: (i) cannabis plants cultivated or obtained under the licence in accordance with a permit; or (ii) cannabis or cannabis resin produced under the licence in accordance with a permit; or (iii) a cannabis drug manufactured 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 a cannabis drug or a narcotic preparation that contains such a drug, 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 drugs, narcotic preparations that contain such a drug or by‑products of cannabis drugs or such narcotic preparations, 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, production or manufacture 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 premises; (i) access to 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: (i) cannabis plants cultivated or obtained under, or purportedly under, the licence; or (ii) cannabis or cannabis resin produced under, or purportedly under, the licence; or (iii) a cannabis drug manufactured under, or purportedly under, the licence; or (iv) a narcotic preparation that contains such a drug; (p) compliance with a code of practice; (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, a cannabis drug or a narcotic preparation that contains such a drug; (t) the labelling of a cannabis drug. (2) The conditions of a medicinal cannabis licence that authorises the cultivation of cannabis plants, or the production of cannabis or cannabis resin, 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 medicinal cannabis licence holder inform people of obligations (1) It is a condition of a medicinal 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; or (ba) to engage in the manufacture of a cannabis drug, or activities related to such manufacture; 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) a licence holder; or (b) a person authorised by a medicinal cannabis licence to engage in a particular activity; is, in the case of the revocation or surrender of the licence, taken to be a reference to a person who was the licence holder, or was so authorised, immediately before the revocation or surrender (as the case may be). #### 10F Condition that medicinal cannabis licence holder employ or engage suitable staff (1) It is a condition of a medicinal 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 medicinal 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 medicinal 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 activities authorised by medicinal cannabis licence are undertaken in accordance with medicinal cannabis permit It is a condition of a medicinal cannabis licence that an activity authorised by the licence (other than an activity of the kind mentioned in paragraph 8E(1)(d)) is undertaken by the licence holder, or by any other person authorised by the licence to undertake the activity, in accordance with a medicinal cannabis permit. #### 10H Condition about monitoring and inspection It is a condition of a medicinal cannabis licence that, if a person is authorised by the licence: (a) to obtain or cultivate cannabis plants, to produce cannabis or cannabis resin or to manufacture a cannabis drug; or (b) to engage in activities relating to such obtaining, cultivation, production or manufacture; the person allow the Secretary, or a person authorised by the Secretary, to: (c) enter premises at which the person is present and where the obtaining, cultivation, production, manufacture or activity is being undertaken, for the purposes of the following: (i) inspecting or monitoring the obtaining, cultivation, production, manufacture or activity; (ii) checking whether the obtaining, cultivation, production, manufacture or activity is being carried out as authorised by the licence in accordance with a medicinal cannabis permit, and whether licence conditions are being complied with; and (d) take samples of any thing at the 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 (the primary licence holder) and another holder of a medicinal cannabis licence that authorises the manufacture of a cannabis drug; or (d) the medicinal cannabis licence of the primary licence holder 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. #### 10JA Condition for medicinal cannabis licence authorising the manufacture of cannabis drugs It is a condition of a medicinal cannabis licence that authorises the manufacture of a cannabis drug for one or more permitted supplies that the licence holder must not supply the drug other than for those permitted supplies. #### 10K Condition that licence holder notify the Secretary of certain matters (1) It is a condition of a medicinal cannabis licence that the licence holder notify the Secretary if 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. (2) The licence holder must notify the Secretary of a matter referred to in subsection (1): (a) if the regulations prescribe a period within which the matter must be notified to the Secretary—before the end of that period; or (b) otherwise—as soon as reasonably practicable after the matter comes to the attention of the licence holder. #### 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 medicinal cannabis licences and medicinal cannabis permits #### 10M Variation of medicinal cannabis licences and medicinal cannabis permits (1) The Secretary may vary a medicinal cannabis licence, or a medicinal cannabis permit that relates to a medicinal 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 medicinal cannabis licence or medicinal cannabis permit, see section 15F. (2) The Secretary may vary a medicinal cannabis licence or a medicinal 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 medicinal cannabis licence or a medicinal 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 medicinal cannabis licence to impose licence conditions or additional licence conditions; or (b) vary a medicinal cannabis licence to remove or vary licence conditions that were imposed by the Secretary under section 8K or this section; or (c) vary a medicinal 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 medicinal cannabis licence or a medicinal 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 medicinal cannabis licence or a medicinal cannabis permit takes effect on the day specified in the notice under subsection (1). #### 10N Applications for variation of medicinal cannabis licences and medicinal cannabis permits (1) An application for a variation of a medicinal cannabis licence or a medicinal cannabis permit must be in writing, 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). (2) The application for a variation must be accompanied by the application fee (if any) prescribed by the regulations. (3) The application may be withdrawn at any time before a decision is made on the application, but the application fee is not refundable. (4) If an application has been made for variation of a medicinal cannabis licence or a medicinal cannabis permit, the Secretary may refuse to vary the licence or permit. > Note: For requirements for a notice of a decision to refuse to vary a medicinal cannabis licence or a medicinal cannabis permit on application, see section 15F. #### 10P Revocation of medicinal cannabis licence and medicinal cannabis permit (1) The Secretary must, by notice in writing given to the holder of a medicinal cannabis licence, revoke the licence if the Secretary is satisfied on reasonable grounds: (a) that the licence holder, or if the licence holder is a body corporate, any of the directors of the body corporate, has engaged in conduct that constitutes a serious offence since the licence was granted; or (b) that the licence holder is no longer a fit and proper person to hold the licence; or (c) that a relevant business associate of the licence holder is not a fit and proper person (whether in relation to a business relating to the licence or in relation to any other business) to be associated with the holder of a medicinal cannabis licence. (1A) A business associate of a licence holder is a relevant business associate if the Secretary considers it is reasonable, in considering the revocation of the licence, to take that business associate into account. (2) The Secretary may, by notice in writing given to the holder of a medicinal cannabis licence, revoke the licence, or a medicinal cannabis permit that relates to that licence, if the Secretary is satisfied on reasonable grounds: (a) that a condition of the licence has been breached; or (b) that the licence holder has engaged in conduct that constitutes an offence against this Act; or (c) that the licence or permit, as the case requires, was obtained or varied on the basis of information that: (i) was false or misleading in a material particular; or (ii) omitted a matter or thing without which the information was misleading in a material particular; or (ca) that any charge payable in respect of the licence is not paid within 28 days after the due date; or (d) that the continuation in force of the licence or permit, as the case requires, would not be consistent with Australia’s obligations under the Convention; or (e) that the location, facilities or security arrangements at the premises at which activities authorised by the licence take place are not suitable for those activities; or (f) that the licence holder has ceased to carry on all activities authorised by the licence; or (g) that activities authorised by the licence to be undertaken at specified premises by the licence holder or another person have been undertaken by the licence holder or the other person, as the case requires, other than at those premises; or (ga) that applicable standards have not been met; or (h) that the licence holder is not taking all reasonable measures to ensure the physical security of cannabis plants, cannabis drugs or narcotic preparations that contain such a drug in the holder’s possession or control; or (i) that the licence holder has not provided information required by a notice given under subsection 14J(2) within the time specified in the notice; or (j) that circumstances prescribed by the regulations for the purposes of this paragraph exist. > Note: The Secretary must have regard to any applicable guidelines (see subsection 26C(2)). (3) The revocation of a medicinal cannabis licence or a medicinal cannabis permit takes effect on the day specified in the notice under subsection (1) or (2). (4) If a medicinal cannabis licence is revoked, any medicinal cannabis permit that relates to the licence is taken to be revoked at the time of the revocation of the licence. > Note: For requirements for a notice of a decision to revoke a medicinal cannabis licence or a medicinal cannabis permit, see section 15F. #### 11 Secretary to notify of proposed revocation (1) Before revoking under section 10P a medicinal cannabis licence, or a medicinal cannabis permit that relates to a medicinal cannabis licence, the Secretary must give written notice of the proposed revocation to the licence holder. (2) A notice under subsection (1) in relation to a medicinal cannabis licence or a medicinal cannabis permit must: (a) state that the Secretary proposes to revoke the licence or permit, as the case requires; and (aa) subject to subsection (5)—state the reasons for the proposed revocation; and (b) invite the licence holder to make a written submission to the Secretary about the proposed revocation. (3) A notice under subsection (1) must specify a period within which the licence holder may make a submission under paragraph (2)(b). The period must not end earlier than 30 days after the day on which the notice was given. (4) In considering whether to revoke a medicinal cannabis licence or a medicinal cannabis permit, the Secretary must have regard to any submission made under paragraph (2)(b). (5) If subsection (1) requires a notice to be given to a licence holder stating the reasons for a proposed revocation as mentioned in paragraph (2)(aa), the Secretary: (a) must not disclose information identified as sensitive law enforcement information under subsection 14LA(1) or (2) in the notice; and (b) if the Secretary relies upon such information in relation to the proposed revocation—must, in the case of information identified under subsection 14LA(1), consult the giver of the information before giving the notice. #### 11A Suspension or surrender of medicinal cannabis licences and medicinal cannabis permits The regulations may make provision for and in relation to the suspension or surrender of medicinal cannabis licences and medicinal cannabis permits. ## Part 3—Offences and civil penalties relating to cannabis plants and cannabis drugs #### 11B Unauthorised cultivation of cannabis plants etc. (1) A person who is a licence holder contravenes this subsection if: (a) the person obtains or cultivates a cannabis plant for the production of cannabis or cannabis resin, or does a thing in connection with such obtaining or cultivation; and (b) the obtaining or cultivation of the cannabis plant, or the doing of the thing, by the person is not authorised by or under a medicinal cannabis licence. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: Imprisonment for 10 years, or 600 penalty units, or both. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 1,000 penalty units. #### 11C Breach of condition of a medicinal cannabis licence—cultivation (1) A person contravenes this subsection if: (a) the person is authorised by a medicinal cannabis licence to cultivate cannabis plants in accordance with a medicinal cannabis permit, or to engage in activities related to such cultivation; and (b) the person breaches a condition of the medicinal cannabis licence; and (c) the condition is not prescribed by the regulations for the purposes of this paragraph. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: Imprisonment for 10 years, or 600 penalty units, or both. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 1,000 penalty units. #### 11D Unauthorised production of cannabis or cannabis resin (1) A person who is a licence holder contravenes this subsection if: (a) the person produces cannabis or cannabis resin, or does a thing in connection with such production; and (b) the production of the cannabis or the cannabis resin, or the doing of the thing, by the person is not authorised by or under a medicinal cannabis licence. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: Imprisonment for 10 years, or 600 penalty units, or both. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 1,000 penalty units. #### 11E Breach of condition of a medicinal cannabis licence—production (1) A person contravenes this subsection if: (a) the person is authorised by a medicinal cannabis licence to produce cannabis or cannabis resin, in accordance with a medicinal cannabis permit, or to engage in activities related to such production; and (b) the person breaches a condition of the medicinal cannabis licence; and (c) the condition is not prescribed by the regulations for the purposes of this paragraph. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: Imprisonment for 10 years, or 600 penalty units, or both. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 1,000 penalty units. #### 11EA Unauthorised manufacture of cannabis drugs (1) A person who is a licence holder contravenes this subsection if: (a) the person manufactures a cannabis drug or does a thing in connection with such manufacture; and (b) the manufacture of the cannabis drug, or the doing of the thing, by the person is not authorised by or under a medicinal cannabis licence. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: Imprisonment for 10 years, or 600 penalty units, or both. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 1,000 penalty units. #### 11EB Breach of condition of a medicinal cannabis licence—manufacture (1) A person contravenes this subsection if: (a) the person is authorised by a medicinal cannabis licence to manufacture a cannabis drug, in accordance with a medicinal cannabis permit, or to engage in activities related to such manufacture; and (b) the person breaches a condition of the licence; and (c) the condition is not prescribed by the regulations for the purposes of this paragraph. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: Imprisonment for 10 years, or 600 penalty units, or both. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 1,000 penalty units. Chapter 3—Licensing the manufacturing of narcotic drugs ## Part 1—Introduction #### 11F Simplified outline of this Chapter A manufacture licence may authorise the manufacture of a narcotic drug and activities related to such manufacture. Before a licence holder can manufacture a narcotic drug, the licence holder must obtain a manufacture permit. Permits deal with matters such as the types and quantities of narcotic drugs that can be manufactured. Certain conditions are imposed on all manufacture licence holders, and the Secretary may impose additional conditions. Manufacture licences and manufacture permits can be varied or revoked in certain circumstances. There are offences and civil penalties relating to the manufacture of narcotic drugs. ## Part 2—Licences and permits ### Division 1—Manufacture licences and permits #### 11G Person may apply for a manufacture licence (1) A person may apply to the Secretary for a licence (a manufacture licence) that authorises one or more of the following activities: (a) the manufacture of a narcotic drug in accordance with one or more manufacture permits; (b) activities relating to such manufacture, including but not limited to the following (as applicable): (i) the supply of the narcotic drug; (ii) the packaging, transport, storage, possession and control of the narcotic drug; (iii) the disposal or destruction of the narcotic drug. (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. #### 11H Secretary must make a decision on an application for a manufacture licence (1) If a person has made an application for a manufacture licence, the Secretary must decide whether to grant, or refuse to grant, the licence. (2) The Secretary may, subject to section 11J, grant a manufacture 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 manufacture licence, the Secretary: (a) must have regard to the following: (i) the information and documents provided by the applicant; (ii) any advice or information received in response to a request or requirement under section 14J, 14K or 14L including, in particular, 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 and to the distribution, use and possession of narcotic drugs manufactured 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 premises at which activities proposed to be authorised by the licence will take place, for the purposes of inspecting the premises. > Note: The Secretary must have regard to any applicable guidelines (see subsection 26C(2)). #### 11J General circumstances in which Secretary must refuse to grant a manufacture licence (1) The Secretary must refuse to grant a manufacture 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 manufacture licence, or in relation to any other business, is a fit and proper person to be associated with the holder of a manufacture licence; or (b) 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 narcotic drugs or narcotic preparations that contain such a drug: (i) in the applicant’s possession or control; and (ii) manufactured 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 premises where activities authorised by the licence will take place; or (ea) the Secretary is not satisfied on reasonable grounds that applicable standards have been or will be met, as the case requires; 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 (ga) the Secretary is satisfied on reasonable grounds that the application for the licence contains information, or information has been given by the applicant in relation to the application, that: (i) is false or misleading in a material particular; or (ii) omits any matter or thing without which the application is misleading in a material respect; 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. #### 11L Secretary may impose conditions If the Secretary grants a manufacture 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 12F. > Note 1: For requirements for a notice of a decision to impose conditions on a manufacture licence, see section 15F. > Note 2: Conditions are also specified in this Act (see sections 12G to 12N), and may also be prescribed by the regulations (see paragraph 12E(b)). #### 11M Notification of decision If the Secretary decides to grant a manufacture 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 11N, to the applicant. > Note: For requirements for a notice of a decision to refuse to grant a manufacture licence, see section 15F. #### 11N Matters to be specified in a manufacture licence A manufacture licence must specify the following: (a) the name of the licence holder; (b) the activities authorised by the licence, including the manufacture of a specified narcotic drug, and the extent to which those activities are authorised only in accordance with one or more manufacture permits held by the licence holder; (c) the premises at which the manufacture of a narcotic drug is authorised by the licence in accordance with one or more manufacture permits; (d) the premises at which other activities relating to such manufacture is authorised by the licence; (e) the persons prescribed by the regulations as the persons who are authorised by the licence to engage in the activities authorised by the licence; (f) the conditions (if any) imposed by the Secretary under section 11L; (g) the period for which the licence is in force; (h) that the Secretary may, in accordance with section 15, require the destruction of any of the following that are in the possession of, or under the control of, the licence holder: (i) a narcotic drug; (ii) a narcotic preparation that contains such a drug. #### 11P Period for which a manufacture licence is in force (1) If a manufacture licence is revoked under subsection 13B(1) or (2), the licence ceases to be in force on the day specified in the notice given under that subsection revoking the licence. (2) If: (a) a manufacture licence is surrendered in accordance with regulations made for the purposes of section 13D; and (b) as a result of that surrender, the licence is to cease to be in force on a particular day, or at a particular time, under those regulations; the licence ceases to be in force on that day, or at that time, unless it ceases to be in force under subsection (1) of this section on an earlier day. (3) If a manufacture licence specifies a period during which the licence is to remain in force, the licence ceases to be in force at the end of that period unless it ceases to be in force under subsection (1) or (2) on an earlier day or at an earlier time. #### 12 Holder of a manufacture licence may apply for a manufacture permit (1) The holder of a manufacture licence may apply for a permit (a manufacture 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. #### 12A Secretary must make a decision on an application for a manufacture permit (1) If the holder of a manufacture licence has made an application for a manufacture 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 manufacture permit if the Secretary considers it appropriate in all the circumstances to do so. (3) The Secretary may refuse to grant a manufacture permit if the Secretary is satisfied on reasonable grounds that the holder of the manufacture licence to which the permit relates has breached a condition of the licence. (4) The Secretary must refuse to grant a manufacture permit if: (a) the application fee (if any) has not been paid; or (aa) the Secretary is not satisfied on reasonable grounds that applicable standards have been or will be met, as the case requires; or (ab) the Secretary is satisfied on reasonable grounds that one or more circumstances exist that are prescribed by the regulations as circumstances in which a permit must not be granted; or (ac) the Secretary is satisfied on reasonable grounds that the application for the permit contains information, or information has been given by the applicant in relation to the application, that: (i) is false or misleading in a material particular; or (ii) omits any matter or thing without which the application is misleading in a material respect; or (b) the applicant has not complied with a requirement under subsection 14J(1) (additional information) in relation to the application. > Note: The Secretary must have regard to any applicable guidelines (see subsection 26C(2)). #### 12B Notification of decision If the Secretary decides to grant a manufacture permit that relates to a manufacture 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 12C, to the licence holder. > Note: For requirements for a notice of a decision to refuse to grant a manufacture permit, see section 15F. #### 12C Matters to be specified in a manufacture permit Without limiting the matters that the Secretary may specify in a manufacture permit that relates to a licence that authorises the manufacture of a narcotic drug, 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 the narcotic drug that may be manufactured at premises specified in the permit; (b) the maximum quantity of the narcotic drug that, in the opinion of the Secretary, having regard to prevailing market conditions, 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 narcotic drug may be manufactured; (d) the period for which the permit is in force; (e) any matter prescribed by the regulations. #### 12D Period for which a manufacture permit is in force (1) If a manufacture permit is revoked under subsection 13B(2), the permit ceases to be in force on the day specified in the notice given under that subsection revoking the permit. (2) If a manufacture permit is taken to be revoked under subsection 13B(4), the permit ceases to be in force at the time referred to in that subsection. (3) If: (a) a manufacture permit is surrendered in accordance with regulations made for the purposes of section 13D; and (b) as a result of that surrender, the permit is to cease to be in force on a particular day, or at a particular time, under those regulations; the permit ceases to be in force on that day, or at that time, unless it ceases to be in force under subsection (1) or (2) of this section on an earlier day or at an earlier time. (4) If a manufacture permit specifies a period during which the permit is to remain in force, the permit ceases to be in force at the end of that period unless it ceases to be in force under subsection (1), (2) or (3) on an earlier day or at an earlier time. ### Division 2—Conditions of manufacture licences #### 12E Manufacture licence is subject to conditions A manufacture licence is subject to the following conditions: (a) the conditions set out in sections 12G to 12N; (b) the conditions (if any) prescribed by the regulations; (c) the conditions (if any) imposed by the Secretary (see sections 11L, 12F and 13). #### 12F Conditions that may be prescribed or imposed The conditions of a manufacture 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 a narcotic drug manufactured under the licence; (d) waste disposal; (e) the destruction of narcotic drugs, narcotic preparations that contain such a drug and by‑products of such drugs or preparations; (f) documentation and record‑keeping in respect of activities to which the licence relates; (g) facilities and containment in respect of the manufacture 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 premises; (i) access to 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 or on a regular basis, 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 a narcotic drug manufactured, under (or purportedly under) the licence, or of a narcotic preparation that contains such a drug; (p) compliance with a code of practice; (q) contingency planning; (r) matters relating to the employment of staff or the engagement of contractors. #### 12G Condition that manufacture licence holder inform people of obligations (1) It is a condition of a manufacture licence that the licence holder inform any person authorised by the licence to engage in the manufacture of narcotic drugs, or activities related to such manufacture, of the following: (a) each condition that is relevant to that person, including each variation or revocation of such a condition; (b) the revocation of the licence and of any permit that relates to the licence and is relevant to the person; (c) 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 manufacture licence is, in the case of revocation of the licence, taken to be a reference to the person who was the licence holder, or was so authorised, immediately before that revocation. #### 12H Condition that manufacture licence holder employ or engage suitable staff (1) It is a condition of a manufacture 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 manufacture 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 manufacture licence, including but not limited to circumstances relating to the following: (a) a person’s criminal record; (b) a person’s employment history. #### 12J Condition that manufacture of narcotic drugs is in accordance with a manufacture permit It is a condition of a manufacture licence that an activity authorised by the licence (other than an activity of the kind mentioned in paragraph 11G(1)(b)) is undertaken by the licence holder, or by any other person authorised by the licence to undertake the activity, in accordance with a manufacture permit. #### 12K Condition about monitoring and inspection It is a condition of a manufacture licence that, if a person is authorised by the licence: (a) to manufacture a narcotic drug; or (b) to engage in activities related to such manufacture; the person allow the Secretary, or a person authorised by the Secretary, to: (c) enter the premises at which the person is present and where the manufacture or activity is being undertaken, for the purposes of the following: (i) inspecting or monitoring the manufacture or activity; (ii) checking whether the manufacture or activity is being carried out as authorised by the licence in accordance with a manufacture permit, and whether licence conditions are being complied with; and (d) take samples of any thing at such premises and remove and test such samples. #### 12N Condition that licence holder notify the Secretary of certain matters (1) It is a condition of a manufacture licence that the licence holder notify the Secretary if 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; (d) any other matter prescribed by the regulations. > Note: Section 24B deals with the privilege against self‑incrimination. (2) The licence holder must notify the Secretary of a matter referred to in subsection (1): (a) if the regulations prescribe a period within which the matter must be notified to the Secretary—before the end of that period; or (b) otherwise—as soon as reasonably practicable after the matter comes to the attention of the licence holder. #### 12P Sections 12G to 12N do not limit conditions that may be imposed or prescribed Sections 12G to 12N do not limit the conditions that may be imposed by the Secretary or prescribed by the regulations. ### Division 3—Variation and revocation of manufacture licences and manufacture permits #### 13 Variation of manufacture licences and manufacture permits (1) The Secretary may vary a manufacture licence, or a manufacture permit that relates to a manufacture 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 manufacture licence or manufacture permit, see section 15F. (2) The Secretary may vary a manufacture licence or a manufacture permit if the Secretary considers it appropriate in all the circumstances to do so. (3) Despite subsection (2), the Secretary must not vary a manufacture licence or a manufacture 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 manufacture licence to impose licence conditions or additional licence conditions; or (b) vary a manufacture licence to remove or vary licence conditions that were imposed by the Secretary under section 11L or this section; or (c) vary a manufacture licence to extend, modify or reduce the activities authorised by the licence; or (d) vary the persons authorised by the licence to engage in activities authorised by the licence. (5) If the Secretary decides to vary a manufacture licence or a manufacture 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 manufacture licence or a manufacture permit takes effect on the day specified in the notice under subsection (1). #### 13A Applications for variation of manufacture licences and permits (1) An application for a variation of a manufacture licence or a manufacture permit must be in writing, 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). (2) The application for a variation must be accompanied by the application fee (if any) prescribed by the regulations. (3) The application may be withdrawn at any time before a decision is made on the application, but the application fee is not refundable. (4) If an application has been made for variation of a manufacture licence or a manufacture permit, the Secretary may refuse to vary the licence or permit. > Note: For requirements for a notice of a decision to refuse to vary a manufacture licence or a manufacture permit on application, see section 15F. #### 13B Revocation of manufacture licence and manufacture permit (1) The Secretary must, by notice in writing given to the holder of a manufacture licence, revoke the licence if the Secretary is satisfied on reasonable grounds: (a) that the licence holder, or if the licence holder is a body corporate, any of the directors of the body corporate, has engaged in conduct that constitutes a serious offence since the licence was granted; or (b) that the licence holder is no longer a fit and proper person to hold the licence; or (c) that a relevant business associate of the licence holder is not a fit and proper person (whether in relation to a business relating to the licence or in relation to any other business) to be associated with the holder of a manufacture licence. (1A) A business associate of a licence holder is a relevant business associate if the Secretary considers it is reasonable, in considering the revocation of the licence, to take that business associate into account. (2) The Secretary may, by notice in writing given to the holder of a manufacture licence, revoke the licence or a manufacture permit that relates to the licence if the Secretary is satisfied on reasonable grounds: (a) that a condition of the licence has been breached; or (b) that the licence holder has engaged in conduct that constitutes an offence against this Act; or (c) that the licence or permit, as the case requires, was obtained or varied on the basis of information that: (i) was false or misleading in a material particular; or (ii) omitted a matter or thing without which the information was misleading in a material particular; or (ca) that any charge payable in respect of the licence is not paid within 28 days after the due date; or (d) that the continuation in force of the licence or permit, as the case requires, would not be consistent with Australia’s obligations under the Convention; or (e) that the location, facilities or security arrangements at the premises at which activities authorised by the licence take place are not suitable for those activities; or (f) the licence holder has ceased to carry on all activities authorised by the licence; or (g) that activities authorised by the licence to be undertaken at specified premises by the licence holder or another person have been undertaken by the licence holder or the other person, as the case requires, other than at those premises; or (ga) that applicable standards have not been met; or (h) that the licence holder is not taking all reasonable measures to ensure the physical security of a narcotic drug, or a narcotic preparation that contains such a drug, in the holder’s possession or control; or (i) that the licence holder has not provided information required by a notice given under subsection 14J(2) within the time specified in the notice; or (j) that circumstances prescribed by the regulations exist. > Note: The Secretary must have regard to any applicable guidelines (see subsection 26C(2)). (3) The revocation of a manufacture licence or a manufacture permit takes effect on the day specified in the notice under subsection (1) or (2). (4) If a manufacture licence is revoked, any manufacture permit that relates to the licence is taken to be revoked at the time of the revocation of the licence. > Note: For requirements for a notice of a decision to revoke a manufacture licence or a manufacture permit, see section 15F. #### 13C Secretary to notify of proposed revocation (1) Before revoking under section 13B a manufacture licence or a manufacture permit that relates to a manufacture licence, the Secretary must give written notice of the proposed revocation to the licence holder. (2) A notice under subsection (1) in relation to a manufacture licence or a manufacture permit must: (a) state that the Secretary proposes to revoke the licence or permit, as the case requires; and (aa) subject to subsection (5)—state the reasons for the proposed revocation; and (b) invite the licence holder to make a written submission to the Secretary about the proposed revocation. (3) A notice under subsection (1) must specify a period within which the licence holder may make a submission under paragraph (2)(b). The period must not end earlier than 30 days after the day on which the notice was given. (4) In considering whether to revoke a manufacture licence or a manufacture permit, the Secretary must have regard to any submission made under paragraph (2)(b). (5) If subsection (1) requires a notice to be given to a licence holder stating the reasons for a proposed revocation as mentioned in paragraph (2)(aa), the Secretary: (a) must not disclose information identified as sensitive law enforcement information under subsection 14LA(1) or (2) in the notice; and (b) if the Secretary relies upon such information in relation to the proposed revocation—must, in the case of information identified under subsection 14LA(1), consult the giver of the information before giving the notice. #### 13D Suspension or surrender of manufacture licences and manufacture permits The regulations may make provision for and in relation to the suspension or surrender of manufacture licences and manufacture permits. ## Part 3—Offences and civil penalties relating to manufacture of narcotic drugs #### 13E Unauthorised manufacture of narcotic drugs (1) A person who is a licence holder contravenes this subsection if: (a) the person manufactures a narcotic drug, or does a thing in connection with such manufacture; and (b) the manufacture of the narcotic drug, or the doing of the thing, by the person is not authorised by or under a manufacture licence. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: Imprisonment for 10 years, or 600 penalty units, or both. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 1,000 penalty units. #### 13F Breach of condition of a manufacture licence (1) A person contravenes this subsection if: (a) the person is authorised by a manufacture licence to manufacture a narcotic drug in accordance with a manufacture permit, or to engage in activities related to such manufacture; and (b) the person breaches a condition of the manufacture licence; and (c) the condition is not prescribed by the regulations for the purposes of this paragraph. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: Imprisonment for 10 years, or 600 penalty units, or both. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 1,000 penalty units. Chapter 4—Monitoring and enforcement ## Part 1—Introduction #### 13G Simplified outline of this Chapter Authorised inspectors have monitoring, inspection and enforcement powers under the Regulatory Powers Act to ensure this Act is being complied with. Specific powers are included for the monitoring of licensed premises. This Chapter also provides for the application of the Regulatory Powers Act in relation to the following: (a) civil penalties; (b) infringement notices; (c) enforceable undertakings; (d) injunctions. ## Part 2—Appointment of authorised inspectors #### 13H Appointment of authorised inspectors (1) The Secretary may, in writing, appoint any of the following persons as an authorised inspector for the purposes of this Act: (a) an APS employee or an officer or employee of a Commonwealth agency; (b) an officer or employee of an agency of a State or Territory that has functions relating to health, agriculture or law enforcement. (2) An authorised inspector is appointed for the period specified in the instrument of appointment. > Note: An authorised inspector is eligible for reappointment (see section 33AA of the Acts Interpretation Act 1901). ## Part 3—Monitoring, inspection, investigation etc. under the Regulatory Powers Act #### 13J Powers of issuing officers Consent to conferral of powers (1) An issuing officer may, by writing, consent to have powers conferred by this Part. Nomination by Minister (2) The Minister may, by writing, nominate an issuing officer in relation to whom a consent is in force under subsection (1) to exercise powers conferred by this Part. Powers conferred personally (3) A power conferred on an issuing officer by this Part is conferred on the issuing officer: (a) in a personal capacity; and (b) in relation to a Judge of a court created by the Parliament—not as a court or a member of a court. Protection and immunity—Deputy Presidents, senior members and general members (4) An issuing officer who is a Deputy President, senior member or general member of the Administrative Review Tribunal exercising a power conferred by this Part has the same protection and immunity as a Justice of the High Court. > Note: Subsections 34(3) and 75(3) of the Regulatory Powers Act confer protection and immunity on a judge exercising the powers of an issuing officer. #### 13K Monitoring powers under Part 2 of the Regulatory Powers Act Provisions subject to monitoring (1) A provision is subject to monitoring under Part 2 of the Regulatory Powers Act if it is: (a) an offence against this Act; or (b) a civil penalty provision of this Act. > Note 1: Part 2 of the Regulatory Powers Act creates a framework for monitoring whether this Act has been complied with. It includes powers of entry and inspection. > Note 2: Part 4 of this Chapter contains special provisions about monitoring licensed premises. Information subject to monitoring (2) Information given in compliance or purported compliance with a provision of this Act is subject to monitoring under Part 2 of the Regulatory Powers Act. > Note: Part 2 of the Regulatory Powers Act creates a framework for monitoring whether the information is correct. It includes powers of entry and inspection. Authorised applicant, authorised person, issuing officer, relevant chief executive and relevant court (3) For the purposes of Part 2 of the Regulatory Powers Act, as it applies in relation to the provisions of this Act: (a) the Secretary is an authorised applicant; and (b) an authorised inspector is an authorised person; and (c) an issuing officer (as defined in subsection 4(1) of this Act) is an issuing officer; and (d) the Secretary is the relevant chief executive; and (e) each relevant court (as defined in subsection 4(1) of this Act) is a relevant court. Person assisting (4) An authorised person may be assisted by other persons in exercising powers or performing functions or duties under Part 2 of the Regulatory Powers Act in relation to the provisions of this Act. #### 13L Modifications of Part 2 of the Regulatory Powers Act Additional monitoring power (1) For the purposes of Part 2 of the Regulatory Powers Act, the additional powers mentioned in subsection (2) are also taken to be monitoring powers for the purposes of determining: (a) whether a provision mentioned in subsection 13K(1) has been, or is being, complied with; or (b) the correctness of information mentioned in subsection 13K(2). (2) The additional monitoring powers are: (a) the power to sample any thing on premises entered under Part 2 of the Regulatory Powers Act; and (b) the power to remove and test such samples. #### 13M Investigation powers under Part 3 of the Regulatory Powers Act Provisions subject to investigation (1) A provision is subject to investigation under Part 3 of the Regulatory Powers Act if it is: (a) an offence against this Act; or (b) a civil penalty provision of this Act. > Note: Part 3 of the Regulatory Powers Act creates a framework for investigating whether a provision has been contravened. It includes powers of entry, search and seizure. Authorised applicant, authorised person, issuing officer, relevant chief executive and relevant court (2) For the purposes of Part 3 of the Regulatory Powers Act, as it applies in relation to evidential material that relates to a provision mentioned in subsection (1): (a) the Secretary is an authorised applicant; and (b) an authorised inspector is an authorised person; and (c) an issuing officer (as defined in subsection 4(1) of this Act) is an issuing officer; and (d) the Secretary is the relevant chief executive; and (e) each relevant court (as defined in subsection 4(1) of this Act) is a relevant court. Person assisting (3) An authorised person may be assisted by other persons in exercising powers or performing functions or duties under Part 3 of the Regulatory Powers Act in relation to evidential material that relates to a provision mentioned in subsection (1). #### 13N Civil penalties under Part 4 of the Regulatory Powers Act Enforceable civil penalty provisions (1) Each civil penalty provision of this Act is enforceable under Part 4 of the Regulatory Powers Act. > Note: Part 4 of the Regulatory Powers Act allows a civil penalty provision to be enforced by obtaining an order for a person to pay a pecuniary penalty for the contravention of the provision. Authorised applicant (2) For the purposes of Part 4 of the Regulatory Powers Act, the Secretary is an authorised applicant in relation to the civil penalty provisions mentioned in subsection (1). Relevant court (3) For the purposes of Part 4 of the Regulatory Powers Act, each relevant court (as defined in subsection 4(1) of this Act) is a relevant court in relation to the civil penalty provisions mentioned in subsection (1). Crown not liable to pecuniary penalty (4) Part 4 of the Regulatory Powers Act, as that Part applies in relation to the civil penalty provisions mentioned in subsection (1), does not make the Crown liable to a pecuniary penalty. #### 13P Provisions subject to an infringement notice (1) The following provisions are subject to an infringement notice under Part 5 of the Regulatory Powers Act: (a) subsection 11B(3); (aa) subsection 11C(3); (b) subsection 11D(3); (c) subsection 11E(3); (ca) subsection 11EA(3); (cb) subsection 11EB(3); (d) subsection 13E(3); (e) subsection 13F(3); (f) subsection 14F(2); (g) subsection 14G(2); (h) subsection 14M(3); (i) subsection 15C(3); (j) subsection 15D(3); (k) subsection 23(3); (l) subsection 24(3); (m) a provision of the regulations that creates an offence of strict liability. (2) For the purposes of Part 5 of the Regulatory Powers Act: (a) the Secretary is an infringement officer in relation to the provisions mentioned in subsection (1); and (b) the Secretary is the relevant chief executive in relation to the provisions mentioned in subsection (1). #### 14 Enforceable undertakings Enforceable provisions (1) The provisions of this Act are enforceable under Part 6 of the Regulatory Powers Act. > Note: Part 6 of the Regulatory Powers Act creates a framework for accepting and enforcing undertakings relating to compliance with provisions. Authorised person (2) For the purposes of Part 6 of the Regulatory Powers Act, the Secretary is an authorised person in relation to the provisions mentioned in subsection (1). Relevant court (3) For the purposes of Part 6 of the Regulatory Powers Act, each relevant court (as defined in subsection 4(1) of this Act) is a relevant court in relation to the provisions mentioned in subsection (1). Publication of undertaking (4) The Secretary may publish an undertaking that relates to this Act on the Department’s website. #### 14A Injunctions Enforceable provisions (1) The provisions of this Act are enforceable under Part 7 of the Regulatory Powers Act. > Note: Part 7 of the Regulatory Powers Act creates a framework for using injunctions to enforce provisions. Authorised person (2) For the purposes of Part 7 of the Regulatory Powers Act, the Secretary is an authorised person in relation to the provisions mentioned in subsection (1). Relevant court (3) For the purposes of Part 7 of the Regulatory Powers Act, each relevant court (as defined in subsection 4(1) of this Act) is a relevant court in relation to the provisions mentioned in subsection (1). #### 14B Extension to external Territories A Part of the Regulatory Powers Act, as it applies in relation to a provision mentioned in this Part, extends to every external Territory to which the provision extends. ## Part 4—Monitoring and searching licensed premises #### 14C Monitoring licensed premises (1) An authorised inspector may enter licensed premises without consent or a warrant for the following purposes: (a) determining whether this Act has been, or is being, complied with; (b) determining whether information provided for the purposes of this Act is correct; (c) deciding whether to exercise a power under this Act. > Note: The expression this Act includes the Regulatory Powers Act as it applies in relation to this Act: see the definition of this Act in subsection 4(1). (2) The authorised inspector may enter the premises during the business hours of the premises. (3) Subdivision A of Division 2 of Part 2, and section 29, of the Regulatory Powers Act apply in accordance with Part 3 of this Chapter as if: (a) entry to the premises was made under section 18 of that Act under a monitoring warrant; and (b) the purposes for which section 18 of that Act permits the monitoring powers to be exercised included the purpose of deciding whether to exercise a power under this Act; and (c) for the purposes of that Subdivision, relevant data included information relevant to deciding whether to exercise a power under this Act. > Note 1: Subdivision A of Division 2 of Part 2, and section 29, of the Regulatory Powers Act are about monitoring powers and compensation for damage to electronic equipment operated under those powers. > Note 2: Section 13L expands the monitoring powers under Subdivision A of Division 2 of Part 2 of the Regulatory Powers Act. (4) The application of Subdivision A of Division 2 of Part 2, and section 29, of the Regulatory Powers Act under subsection (3) of this section is in addition to their application under Part 3 of this Chapter. #### 14D Announcement before entry Before an authorised inspector enters licensed premises under a provision referred to in section 14C, the authorised inspector must: (a) announce that he or she is authorised to enter the premises; and (b) if the occupier of the premises is present at the premises: (i) ensure that the identity card of the authorised inspector is shown to the occupier; and (ii) explain the reasons for entering the premises. #### 14E Occupier is entitled to observe exercise of powers (1) The occupier of licensed premises entered under section 14C is (subject to subsections (2) and (3) of this section) entitled to observe the exercise of powers while on the premises if the occupier is present at the premises while those powers are being exercised. (2) The right to observe the exercise of powers ceases if the occupier impedes the exercise of those powers. (3) This section does not prevent powers being exercised in 2 or more areas of the premises at the same time. #### 14F Occupier to provide officers etc. with facilities and assistance (1) The occupier of licensed premises entered under section 14C must provide the following persons with all reasonable facilities and assistance for the effective exercise of their powers while on the premises: (a) any authorised inspector who enters the premises; (b) any person assisting the authorised inspector. Strict liability offence (2) A person commits an offence of strict liability if: (a) the person is subject to subsection (1); and (b) the person fails to comply with that subsection. Penalty: 30 penalty units. #### 14G Obstruction or hindrance of authorised inspectors (1) A person must not obstruct or hinder an authorised inspector who is performing functions or exercising powers under this Act. Strict liability offence (2) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 30 penalty units. Chapter 5—General ## Part 1—Introduction #### 14H Simplified outline of this Chapter This Chapter enables the Secretary to obtain information and documents from applicants for licences and licence holders. This Chapter also enables the Secretary to request information and documents from other persons, and to require information and documents from certain agencies. The Secretary is authorised to release information and documents obtained under or for the purposes of this Act. The Secretary has directions powers with respect to the security of premises and the handling and destruction of cannabis plants, cannabis drugs, narcotic drugs and narcotic preparations that contain such drugs. This Chapter also deals with internal and external review of decisions. This Chapter also contains provisions dealing with matters such as: (a) requirements relating to drugs passing through Australia; and (b) delegating powers and functions under this Act; and (c) serving notices; and (d) making regulations for the purposes of this Act. ## Part 2—Obtaining and disclosing information and documents ### Division 1—Obtaining information and documents for purposes relating to licences #### 14J Secretary may require further information or documents (1) The Secretary may, by notice in writing, require an applicant for a licence or a permit, or for a variation of such a licence or permit, to give the Secretary such further information or documents in relation to the application as the Secretary reasonably requires. (2) The Secretary may, by notice in writing, require the holder of a licence to give the Secretary such further information or documents about matters relating to the licence as the Secretary reasonably requires, including but not limited to the following matters: (a) activities engaged in under, or purportedly under, the licence; (b) conditions of the licence; (c) variation or revocation of the licence; (d) matters relating to one or more permits that relate to the licence. (3) A notice under subsection (1) or (2) may specify a period, which must be reasonable in all the circumstances and must not be less than 14 days, within which the information or documents are to be given. (4) The Secretary may require information or documents to be given under this section at any time, and on one or more occasions: (a) if the information or documents relate to an application for a licence or a permit, or for a variation of such a licence or permit—before the Secretary makes a decision on the application, whether before or after the Secretary has begun to consider the application; or (b) if the information or documents otherwise relate to a licence—at any time while the licence is in force. (5) To avoid doubt, the information or documents that the Secretary may require include information or documents about whether a person is a fit and proper person to hold a licence or to be associated with the holder of a licence. > Note: Section 24B deals with the privilege against self‑incrimination. #### 14K Secretary may request information or documents from any source (1) The Secretary may request information, documents or advice relevant to an application for a licence or a permit, or otherwise in relation to a licence or permit, from any source, including an agency of the Commonwealth. (2) If the Secretary requests personal information about an individual, the giving of the information by the person to whom the request is made, and the collection of the information, is taken to be authorised by this Act for the purposes of the Privacy Act 1988 and the Australian Border Force Act 2015. (3) This section is not limited by section 14L. #### 14L Secretary may require information or documents from other sources (1) The Secretary may, by written notice, require the head of a State or Territory agency to give the Secretary information or documents that: (a) are relevant to an application for a licence or a permit, a variation or revocation of a licence or permit or otherwise in relation to a licence or permit; and (b) are of a kind specified in the notice; and (c) relate to a person, location or premises specified in the notice. > Note: For specification by class, see subsection 33(3AB) of the Acts Interpretation Act 1901. (2) The Secretary must not give a notice under subsection (1) to the head of an agency unless the Secretary reasonably believes: (a) that the head of the agency has, or can reasonably acquire, the information or documents; and (b) that the information or documents are relevant for the purposes of considering an application for a licence or permit, or are otherwise relevant to a licence or permit. (3) The head of an agency who is given a notice under subsection (1) must, as soon as practicable after the notice is given, comply with the notice to the extent that he or she has, or can reasonably acquire, the information or documents specified in the notice. (3A) Despite subsection (3), the head of an agency is not required to give the Secretary information if: (a) the holder of the information has advised the head of the agency that the holder knows or believes that the information is sensitive law enforcement information; and (b) the head of the agency informs the Secretary of that advice. (4) Despite subsection (3), the registrar (however described) of a court is not required to comply with a notice under subsection (1) to the extent that the information or documents specified in the notice, in relation to a person specified in the notice, are information or documents that relate to proceedings that have not been finally determined by the court. (5) The head of an agency is authorised to comply with a notice under subsection (1), even if the giving or collecting of the information or documents specified in the notice would contravene a law of a State or a Territory that: (a) primarily relates to the protection of the privacy of individuals; and (b) prohibits or regulates the use or disclosure of personal information. (6) A person is not liable to: (a) any proceedings for contravening a provision of a law referred to in subsection (5); or (b) civil proceedings for loss, damage or injury of any kind suffered by another person; merely because the person gives information or documents to the Secretary, or collects information or documents, for the purposes of ensuring that the head of an agency complies with a notice under subsection (1). (7) If the Secretary requires personal information about an individual, the giving of the information by the person to whom the request is made, and the collection of the information, is taken to be authorised by this Act for the purposes of the Privacy Act 1988. #### 14LA Identification of sensitive law enforcement information (1) If: (a) the Secretary: (i) requests a Commonwealth, State or Territory law enforcement agency to give information, documents or advice to the Secretary under section 14K; or (ii) requires the head of a State or Territory law enforcement agency to give information or documents to the Secretary under section 14L; and (b) such information, documents or advice is given to the Secretary; and (c) the person who gave the information, documents or advice to the Secretary knows or believes that the information is, or the documents or advice include information that is, sensitive law enforcement information; the person must, at the time of giving the information, documents or advice or subsequently, identify the information that the person knows or believes is sensitive law enforcement information. (2) If: (a) the Secretary has information; and (b) the information was not given to the Secretary by a Commonwealth, State or Territory law enforcement agency; and (c) the Secretary knows or believes that the information is sensitive law enforcement information; the Secretary must identify the information that the Secretary knows or believes is sensitive law enforcement information. #### 14M Failure to give information or documents within specified period (1) A person contravenes this subsection if: (a) the person is required by notice under subsection 14J(2) to give information or documents to the Secretary; and (b) the notice specifies the period within which the information or documents are to be given; and (c) the person does not give the information or documents within the specified period. > Note: Division 137 of the Criminal Code creates offences for providing false or misleading information or documents. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: 100 penalty units. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 500 penalty units. ### Division 2—Disclosure of certain information #### 14MA Secrecy—unauthorised disclosures of sensitive law enforcement information (1) A person commits an offence if: (a) the person has information obtained in connection with the performance of a function, or the exercise of a power, by the person under this Act; and (b) the information is information identified as sensitive law enforcement information under subsection 14LA(1) or (2); and (c) the person: (i) discloses the information to another person; or (ii) uses the information. Penalty: Imprisonment for 2 years or 120 penalty units, or both. (2) Subsection (1) does not apply if: (a) the disclosure or use by the person is for the purposes of, or in connection with, the performance of a function or the exercise of a power under this Act; or (b) the disclosure or use by the person is in compliance with a requirement under a law of the Commonwealth; or (c) the person or agency that gave the information to the Secretary consents to the disclosure or use; or (d) the disclosure or use is required by a court or tribunal for the purposes of, or in connection with, proceedings for the purposes of giving effect to this Act or another law of the Commonwealth; or (e) the information, or a document or advice that included the information, was given to the Secretary by a person or an agency under section 14K or 14L, and the use or disclosure is by that person or that agency. > Note: A defendant bears an evidential burden in relation to a matter in subsection (2) (see subsection 13.3(3) of the Criminal Code). #### 14N Authorised disclosures of information Subject to section 14MA, a disclosure by the Secretary of information is authorised for the purposes of the Privacy Act 1988 if: (a) the disclosure is in the course of performing functions or duties, or exercising powers, under this Act; or (b) the disclosure is for the purposes of this Act; or (c) the disclosure is required or authorised by or under a law of the Commonwealth, a State or a Territory; or (d) the person to whom the information relates consents to the disclosure; or (e) the disclosure is to an agency of the Commonwealth, a State or a Territory that is responsible for, or deals with, matters relating to health, therapeutic goods, poisons, industrial chemicals, agriculture, environmental matters, land management or the registration of pharmacies or the regulation of pharmacists; or (f) the disclosure is to a Commonwealth, State or Territory law enforcement agency; or (g) the information has already been lawfully made available to the public; or (h) the disclosure is in circumstances prescribed by the regulations, being circumstances that relate to public safety, research relating to medicinal cannabis or the regulation of health professionals. ## Part 3—Directions powers #### 14P Directions with respect to security of premises and handling of things The Secretary may, by notice in writing given to a person who is a licence holder, or who has been a licence holder: (a) direct the person to take specified measures for ensuring the security of premises at which activities authorised by the licence are, were or may be, occurring; or (b) direct the person to take specified measures for regulating or controlling the entry of persons or vehicles into, or the departure of persons or vehicles from, such premises; or (c) direct the person to take specified measures for preventing the entry of persons or vehicles into, or the departure of persons or vehicles from, such premises other than at specified places; or (d) give such other directions to the person as the Secretary considers appropriate in relation to the following: (i) cannabis plants obtained or cultivated by the person or in the person’s possession or control; (ii) cannabis or cannabis resin produced by the person or in the person’s possession or control; (iii) drugs or narcotic preparations manufactured by the person or in the person’s possession or control, or substances used in such manufacture in the person’s possession or control; including, but not limited to, directions in relation to their handling at a place other than the premises at which the obtaining, cultivation, production or manufacture occurred; or (e) give such other directions to the person, in relation to the licence or a permit that relates to the licence, as the Secretary considers appropriate. > Note: For requirements for a notice of a decision to give a direction under this section, see section 15F. #### 15 Directions with respect to destruction, etc. (1) The Secretary may, by notice in writing given to a person who is, or has been, the holder of a medicinal cannabis licence, require the destruction of, or other dealings with, cannabis plants, cannabis or cannabis resin in the person’s possession or control, if the Secretary is satisfied on reasonable grounds that: (a) the cannabis plants were cultivated or obtained, or the cannabis or cannabis resin was produced, in breach of the licence; or (b) the cannabis plants were cultivated or obtained, or the cannabis or cannabis resin was produced, in circumstances prescribed by the regulations; or (c) circumstances prescribed by the regulations for the purposes of this paragraph exist. (1A) The Secretary may, by notice in writing given to a person who is, or has been, the holder of a licence, require the destruction of, or other dealings with, a drug or a narcotic preparation that contains a drug in the person’s possession or control, if the Secretary is satisfied on reasonable grounds that: (a) the drug or the drug contained in the narcotic preparation was manufactured in breach of the licence; or (b) the drug or the drug contained in the narcotic preparation was manufactured in circumstances prescribed by the regulations; or (c) circumstances prescribed by the regulations for the purposes of this paragraph exist. (2) If the Secretary requires the destruction of, or other dealing with, cannabis plants, cannabis, cannabis resin, drugs or narcotic preparations the Secretary may: (a) direct the person to whom the notice was given under subsection (1) or (1A), or a person in charge of the cannabis plants, cannabis, cannabis resin, drugs or narcotic preparations, to carry out the destruction or dealing; or (b) carry out the destruction or dealing; or (c) arrange for another person with appropriate qualifications or expertise to carry out the destruction or dealing. (3) If the Secretary: (a) directs the destruction of, or other dealing with, cannabis plants, cannabis, cannabis resin, drugs or narcotic preparations as mentioned in paragraph (2)(a); or (b) arranges for such destruction or dealing as mentioned in paragraph (2)(c); the Secretary may supervise the destruction or dealing. (4) If the Commonwealth incurs costs because of a requirement under this section: (a) the person to whom the notice was given under subsection (1) or (1A) is liable to pay to the Commonwealth an amount equal to the costs; and (b) the amount may be recovered by the Commonwealth as a debt due to the Commonwealth in a court of competent jurisdiction. > Note: For requirements for a notice of a decision to give a direction under this section, see section 15F. #### 15A Directions with respect to manufacturing and labelling of drugs The Secretary may, by notice in writing given to a person who is the holder of a licence, give directions to the person with respect to: (a) operations connected with the manufacturing of drugs or narcotic preparations; or (b) the labelling of drugs or narcotic preparations; manufactured by the person. > Note: For requirements for a notice of a decision to give a direction under this section, see section 15F. #### 15B General matters about directions (1) This section applies to a direction under section 14P, 15 or 15A. (2) To avoid doubt, the direction may be given: (a) in respect of cannabis plants, cannabis, cannabis resin, drugs or narcotic preparations generally; or (b) in respect of cannabis plants, cannabis, cannabis resin, drugs or narcotic preparations of a kind specified in the direction; or (c) in respect of particular cannabis plants, cannabis, cannabis resin, drugs or narcotic preparations specified in the direction. (3) If the direction is inconsistent with a condition of a licence (whether the condition is specified in the licence or imposed by this Act), the condition is of no effect to the extent of the inconsistency. #### 15C Failure to comply with a direction (1) A person contravenes this subsection if: (a) the person is given a direction under: (i) section 14P or 15; or (ii) paragraph 15A(a); and (b) the person does not comply with the direction. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: 300 penalty units. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 600 penalty units. #### 15D Supply of a drug or narcotic preparation not labelled in accordance with a direction (1) A person contravenes this subsection if: (a) the person is given a direction under paragraph 15A(b) (labelling of drugs and narcotic preparations); and (b) the person supplies a drug or narcotic preparation that is not labelled in accordance with the direction. Fault‑based offence (2) A person commits an offence if the person contravenes subsection (1). > Note: See section 24A in relation to the physical elements of the offence. Penalty: 300 penalty units. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (1). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (1). Civil penalty: 600 penalty units. ## Part 4—Review of decisions #### 15E Reviewable decisions (1) Each of the following decisions of the Secretary is a reviewable decision: (a) a decision under section 8F to grant a medicinal cannabis licence; (b) a decision under section 8F to refuse to grant a medicinal cannabis licence; (c) a decision under section 8K to impose conditions on a medicinal cannabis licence; (d) a decision under section 9 to grant a medicinal cannabis permit; (e) a decision under section 9 to refuse to grant a medicinal cannabis permit; (k) a decision under subsection 10M(1) to vary a medicinal cannabis licence or a medicinal cannabis permit; (l) a decision under subsection 10N(4) to refuse to vary a medicinal cannabis licence or a medicinal cannabis permit on application; (m) a decision under section 10P to revoke a medicinal cannabis licence or a medicinal cannabis permit; (n) a decision under section 11H to refuse to grant a manufacture licence; (o) a decision under section 11L to impose conditions on a manufacture licence; (p) a decision under section 12A to refuse to grant a manufacture permit; (q) a decision under subsection 13(1) to vary a manufacture licence or a manufacture permit; (r) a decision under subsection 13A(4) to refuse to vary a manufacture licence or a manufacture permit on application; (s) a decision under section 13B to revoke a manufacture licence or a manufacture permit; (t) a decision under section 14P or 15 to give a direction to the holder or former holder of a licence; (u) a decision under section 15A to give a direction to the holder of a licence. (2) The regulations may also provide that a decision made under a specified provision of this Act is a reviewable decision. > Note: The reference to this Act includes a reference to instruments made under this Act (see the definition of this Act in subsection 4(1)). #### 15F Notice of reviewable decisions (1) After a reviewable decision is made, the person who made the decision must, as soon as practicable, give a written notice to the applicant for, or the holder or former holder of, the licence or permit concerned, containing: (a) the terms of the decision; and (b) subject to subsection (2A)—the reasons for the decision; and (c) notice of the person’s right to have the decision reviewed. (2) In addition to giving notice under subsection (1), if: (a) the reviewable decision is a decision referred to in: (i) paragraph 15E(1)(a); or (ii) paragraph 15E(1)(k), to the extent that the paragraph relates to the variation of a medicinal cannabis licence; and (b) the medicinal cannabis licence concerned relates to premises situated wholly or partly in a State or Territory; and (c) a notice under subsection 25B(1), given by the head of a State or Territory agency for that State or Territory, is in force; the person who made the decision must, as soon as practicable, give a written notice to the head of the State or Territory agency, containing: (d) the terms of the decision; and (e) subject to subsection (2A)—the reasons for the decision; and (f) notice of the right of the State or Territory agency to have the decision reviewed. (2A) If subsection (1) or (2) requires a notice to be given stating the reasons for a reviewable decision as mentioned in paragraph (1)(b) or (2)(e), the person who made the decision: (a) must not disclose information identified as sensitive law enforcement information under subsection 14LA(1) or (2) in the notice; and (b) if the person who made the decision relies upon such information in making the reviewable decision—must, in the case of information identified under subsection 14LA(1), consult the giver of the information before giving the notice. (3) This section does not affect any requirement to give notice of a reviewable decision under another provision of this Act. #### 15G Internal review of reviewable decisions—application for review (1) A person to whom a notice is given under subsection 15F(1) or (2) in relation to a reviewable decision may apply to the Minister for review of the decision. (2) An application for review must: (a) be in writing; and (b) set out the reasons for the application; and (c) be made within 90 days after the date of the notice under subsection 15F(1) or (2), as the case requires. > Note: Under section 15K, further information may be required in relation to an application. #### 15H Internal review of reviewable decisions—review of decision (1) On receiving an application for review of a reviewable decision, the Minister must either: (a) review the reviewable decision personally; or (b) cause the reviewable decision to be reviewed by a person (the internal reviewer) who: (i) is a person to whom the Minister’s power to review the decision has been delegated; and (ii) was not involved in making the decision; and (iii) occupies a position at least as senior as the person who actually made the decision. (2) In reviewing the reviewable decision: (a) the Minister or the internal reviewer must take into account any information included in the application for review; and (b) the Minister or the internal reviewer must not take into account any other information provided by, or on behalf of, the applicant after the making of the application, other than information provided in response to a notice under section 15K. (3) Paragraph (2)(b) does not otherwise limit the information the Minister or the internal reviewer may take into account in reviewing the reviewable decision. (4) The Minister or the internal reviewer may: (a) affirm, vary or set aside the reviewable decision; and (b) if he or she sets aside the reviewable decision—make such other decision as he or she thinks appropriate. (5) The decision (the decision on review) of the Minister or the internal reviewer takes effect: (a) on the day specified in the decision on review; or (b) if a day is not specified—on the day the decision on review was made. #### 15J Internal review of reviewable decisions—notice of decision (1) After a decision on review is made under section 15H, the person who made the decision on review must give the applicant a written notice containing: (a) the terms of the decision; and (b) subject to subsection (4)—the reasons for the decision; and (c) notice of the applicant’s right to have the decision reviewed by the Administrative Review Tribunal. Deemed affirmation—failure to give notice (2) For the purposes of section 15L (review by the ART), the Minister is taken to have affirmed a reviewable decision if the applicant does not receive notice of a decision on review within 60 days after the application for review was made. Time does not run while further information being sought (3) If the Minister or the internal reviewer has given a notice under section 15K requiring further information about an application for review, a day is not to be counted for the purposes of subsection (2) if it is: (a) on or after the date of the notice; and (b) on or before the day the Minister or the internal reviewer notifies the applicant that the further information provided satisfies the requirement. (4) If subsection (1) requires a notice to be given stating the reasons for a decision on review as mentioned in paragraph (1)(b), the Minister or internal reviewer: (a) must not disclose information identified as sensitive law enforcement information under subsection 14LA(1) or (2) in the notice; and (b) if the Minister or internal reviewer relies upon such information in making the decision on review—must, in the case of information identified under subsection 14LA(1), consult the giver of the information before giving the notice. #### 15K Minister or internal reviewer may require further information The Minister or an internal reviewer may, by written notice, require a person who has made an application under section 15G to give the Minister or the internal reviewer further information about the application. #### 15L Review of decisions under this Division by Administrative Review Tribunal (1) Applications may be made to the Administrative Review Tribunal for review of decisions of the Minister, or an internal reviewer, under section 15H that relate to a reviewable decision. (2) If the reviewable decision is a decision of a kind referred to in subsection 15F(2) then, for the purposes of an application for review referred to in subsection (1) of this section, the State or Territory concerned may be a person whose interests are affected for the purposes of the Administrative Review Tribunal Act 2024. #### 15M Application by Secretary to Administrative Review Tribunal (1) This section applies if an application is made to the Administrative Review Tribunal for review of a decision of the Minister, or an internal reviewer, that relates to a reviewable decision. (2) The Secretary may, at any time, apply to the Administrative Review Tribunal to make an order under subsection 69(3) or 70(1) or (2) of the Administrative Review Tribunal Act 2024 in relation to the review including, but not limited to, an order in relation to information identified as sensitive law enforcement information under subsection 14LA(1) or (2) of this Act. (3) If the Secretary makes an application under subsection (2), the Administrative Review Tribunal may make an order of a kind referred to in that subsection if the Tribunal is satisfied that to do so is necessary in order to: (a) avoid disruption to national or international efforts relating to law enforcement, criminal intelligence, criminal investigation, foreign intelligence, security intelligence or the integrity of law enforcement agencies; or (b) protect the technologies and methods used to collect, analyse, secure or otherwise deal with criminal intelligence, foreign intelligence, security intelligence or intelligence relating to the integrity of law enforcement agencies; or (c) protect and ensure the safety of: (i) informants or witnesses, or persons associated with informants or witnesses; or (ii) persons involved in the protection or safety of informants or witnesses; or (d) ensure that intelligence and law enforcement agencies are not discouraged from giving information to a nation’s government and government agencies. #### 15N Failure to include information identified as sensitive law enforcement information in certain statements (1) This section applies if an application may be made by a person (the applicant) to the Administrative Review Tribunal for review of a decision of the Minister, or an internal reviewer, that relates to a reviewable decision. (2) The applicant is not entitled to make a request for a statement under section 268 of the Administrative Review Tribunal Act 2024, merely because a document or statement referred to in subsection 269(7) of that Act does not include information identified as sensitive law enforcement information under subsection 14LA(1) or (2) of this Act. (3) If, despite subsection (2), the applicant is entitled to make a request under section 268 of the Administrative Review Tribunal Act 2024 for a statement in relation to the decision: (a) the statement is not required to include information identified as sensitive law enforcement information under subsection 14LA(1) or (2) of this Act; and (b) the applicant is not entitled to be given such information; and (c) merely because the statement does not include such information, the statement is not to be taken to fail to include: (i) adequate particulars of findings on material questions of fact; or (ii) an adequate reference to the evidence or other material on which those findings were based; or (iii) adequate particulars of the reasons for the decision. ## Part 5—Other matters #### 21 Forfeiture Where a court convicts a person of an offence against this Act, the court may, if it thinks fit, in addition to any other punishment, order the forfeiture of any goods in respect of which the offence was committed. #### 21A Operation of natural justice hearing rule If the natural justice hearing rule would, but for the provisions of this Act, require the disclosure of information identified as sensitive law enforcement information under subsection 14LA(1) or (2), this Act is taken to be an exhaustive statement of the requirements of the natural justice hearing rule in relation to the disclosure of that information. #### 22 Drugs passing through Australia (1) Where a drug consigned to a person, or to a place, outside Australia enters Australia, a Collector may, whether or not the drug is unloaded from the vessel or aircraft in which it entered Australia, require a person having possession or control of the drug to produce to the Collector an export authorization, or a copy of an export authorization, relating to the drug. (2) If the export authorization is not produced to the Collector, the Collector may cause the drug to be seized. (3) A drug seized under the last preceding subsection shall be disposed of in accordance with the directions of the Comptroller‑General of Customs. (4) For the purposes of this section, a drug on board a vessel or aircraft, whether or not it is the vessel or aircraft on which the drug entered Australia, shall be deemed to be in the possession of the master of the vessel or captain of the aircraft, as the case requires. (5) In this section, export authorization, in relation to a drug, means any export authorization issued by or on behalf of the government of a country in pursuance of the Convention or the Second Opium Conference Convention signed at Geneva on 19 February 1925, or in pursuance of a law of that country giving effect to either of those Conventions. #### 23 Requirement to keep records and furnish reports (1) The Secretary may, by notice in writing served on a person who is a manufacturer of narcotic preparations (other than a person who is the holder of a medicinal cannabis licence that authorises the manufacture of a cannabis drug or is the holder of a manufacture licence) or a wholesale dealer in drugs or narcotic preparations, require that person to keep such records, and to furnish to the Secretary such returns and information, as are specified in the notice with respect to the following matters or such of those matters as are specified in the notice: (a) the manufacture of narcotic preparations by the person; (b) the acquisition and disposal of, and any other dealings in, drugs and narcotic preparations by the person; and (c) the stocks of drugs and narcotic preparations from time to time in the possession or control of the person. (2) A person contravenes this subsection if: (a) the person is given a notice under subsection (1); and (b) the person does not comply with the notice. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (2). Penalty: 60 penalty units. Civil penalty provision (4) A person is liable to a civil penalty if the person contravenes subsection (2). Civil penalty: 500 penalty units. #### 24 Inspection of certain premises (1) An authorised inspector may, at any reasonable time and on production of his or her identity card, enter the premises of any person who, in accordance with notice served on him or her under the last preceding section, is for the time being required to keep records and furnish returns and information with respect to any matter, being premises on which narcotic preparations are manufactured or the business of a wholesale dealer in drugs is carried on, and may: (a) examine, take stock of and take samples of any drug or narcotic preparation on the premises or any substance on the premises from which any drug or narcotic preparation could be manufactured or which is a by‑product derived from the manufacture of a drug or narcotic preparation; (b) inspect any processes of manufacture of any drug or narcotic preparation carried out on the premises; and (c) inspect any books, documents or other papers on the premises, and take extracts from, or make copies of, any such books, documents or other papers. (2) A person contravenes this subsection if: (a) the person is the occupier of, or is in charge of, premises; and (b) an authorised inspector enters the premises under subsection (1); and (c) the person does not provide the authorised inspector with reasonable facilities and assistance for the effective exercise of the inspector’s powers. Strict liability offence (3) A person commits an offence of strict liability if the person contravenes subsection (2). Penalty: 60 penalty units. Civil penalty provision (3A) A person is liable to a civil penalty if the person contravenes subsection (2). Civil penalty: 500 penalty units. (3C) Subsection (3) does not apply if the occupier or person in charge has a reasonable excuse. > Note: The defendant bears an evidential burden in relation to the matter in subsection (3C). See subsection 13.3(3) of the Criminal Code. #### 24A Physical elements of offences (1) This section applies if a provision of this Act provides that a person contravening another provision of this Act (the conduct rule provision) commits an offence. (2) For the purposes of applying Chapter 2 of the Criminal Code to the offence, the physical elements of the offence are set out in the conduct rule provision. > Note: Chapter 2 of the Criminal Code sets out general principles of criminal responsibility. #### 24B Privilege against self‑incrimination Person not entitled to refuse to provide information (1) A person is not excused from giving information under section 10K, 12N or 14J on the ground that the information might tend to incriminate the person or expose the person to a penalty. Use immunity applies to information (2) However, in the case of an individual: (a) the information given; and (b) giving the information; are not admissible in evidence against the individual in any criminal proceedings, or in proceedings for contravention of a civil penalty provision, except proceedings under, or arising out of any of the following in relation to the giving of the information: (c) subsection 14M(1) of this Act; (d) section 137.1 or 137.2 of the Criminal Code (false or misleading information or documents); (e) subsection 149.1(1) of the Criminal Code (obstruction of Commonwealth public officials). #### 24C Licences not transferable Nothing in this Act permits a licence to be transferred from a licence holder to another person. #### 25 Delegation (1) The Health Minister or the Secretary may, either generally or as otherwise provided by the instrument of delegation, by writing signed by him or her, delegate to a person any of his or her powers and functions under this Act, other than this power of delegation. (2) A power or function so delegated, when exercised or performed by the delegate shall, for the purposes of this Act, be deemed to have been exercised or performed by the Health Minister or the Secretary, as the case may be. (3) A delegation under this section does not prevent the exercise of a power or the performance of a function by the Health Minister or the Secretary, as the case may be. (4) The Minister or the Secretary must not delegate a power or function under subsection (1) to an officer or employee of an agency of a State or a Territory without the agreement of the State or the Territory, as the case requires. (5) The Secretary must not delegate a power or function under subsection 14LA(2) (identifying sensitive law enforcement information) to a person other than an SES employee, or acting SES employee, in the Department. > Note: The expressions SES employee and acting SES employee are defined in the Acts Interpretation Act 1901. #### 25B Secretary to notify States and Territories of certain matters (1) The head of a State or Territory agency may notify the Secretary in writing that the State or Territory wishes to be advised if a licence or permit that relates to premises situated wholly or partly in the State or Territory is granted, varied or revoked. (2) If: (a) a notice under subsection (1) given by the head of a State or Territory agency is in force; and (b) a licence or permit that relates to premises situated wholly or partly in the State or Territory is granted, varied or revoked; the Secretary must advise the head of the State or Territory agency, in writing, of the matters prescribed by the regulations for the purposes of this subsection. #### 26 Service of notices (1) The service on a person of a notice under this Act may be effected: (a) by serving the notice personally on the person or, in the case of a body corporate, on the manager, secretary or other executive officer of the body corporate; or (b) by sending the notice by post to the person at his or her last known place of abode or, in the case of a body corporate having a registered office, at the registered office of the body corporate; or (ba) by sending the notice to the person by fax, email or other electronic means to the last fax number, email address or other electronic address that the Secretary has for the person; or (c) in any other prescribed manner. (2) A notice or document sent to a fax number, email address or other electronic address is taken to have been given on the business day after it is sent. #### 26B Minister may issue standards (1) The Minister may, by legislative instrument, issue standards for the purposes of this Act. (2) Despite section 14 of the Legislation Act 2003, the standards may make provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing as in force or existing from time to time. #### 26C Minister may issue guidelines (1) The Minister may, by written instrument, issue guidelines for the purposes of this Act. > Note: For variation and revocation of the instrument, see subsection 33(3) of the Acts Interpretation Act 1901. (2) A person who performs a function or exercises a power under this Act must have regard to any guidelines that are applicable. (3) Guidelines are not legislative instruments. (4) Despite section 46AA of the Acts Interpretation Act 1901, the guidelines may make provision in relation to a matter by applying, adopting or incorporating any matter contained in an instrument or other writing as in force or existing from time to time. #### 27 Regulations General (1) The Governor‑General may make regulations prescribing matters: (a) required or permitted by this Act to be prescribed by the regulations; or (b) necessary or convenient to be prescribed for carrying out or giving effect to this Act. Requirements for premises at which licensed activities carried out (2) The regulations may prescribe requirements in relation to premises at which activities authorised by licences under this Act are carried out. (3) Without limiting the matters that may be dealt with by regulations made under subsection (2), the regulations may deal with the following: (a) access to the premises by persons; (b) conditions of entry, the issue and use of security passes and other identification systems by employees and other people. Other matters (4) The regulations may provide for or in relation to the following: (a) testing of samples; (aa) scientific uses of samples; (b) authorising people engaged by licence holders, but not otherwise authorised by a licence, to transport cannabis plants, cannabis and cannabis resin obtained, cultivated or produced under a licence; (d) regulating, restricting or prohibiting premises, vehicles, equipment or machines used, or intended to be used, for or in connection with activities relating to licences; (e) regulating, restricting or prohibiting the advertising to the public of cannabis plants, cannabis or cannabis resin by licence holders; (f) regulating the manner in which cannabis plants, cannabis drugs and narcotic preparations that contain such a drug are presented for supply; (g) modifying the operation of Chapters 2 and 3 of this Act if an applicant for a licence, or a licence holder, is an agency of the Commonwealth, a State or a Territory; (h) empowering the Secretary to do things in relation to cannabis plants, cannabis, cannabis resin, drugs and narcotic preparations that have been seized under this Act; (i) how forfeited goods are dealt with. #### 28 General provisions relating to regulations (1) The regulations may provide for: (a) the imposition of penalties of not more than 50 penalty units for a contravention of a provision of the regulations; and (b) the imposition of civil penalties for contraventions of a kind referred to in paragraph (a) of not more than: (i) 50 penalty units for an individual; or (ii) 250 penalty units for a body corporate; and (c) the charging of fees in respect of any matters under this Act; and (d) matters relating to the payment of fees, including the following: (i) time and manner of payment; (ii) pro‑rating, refunds, reduction, remission or waiving; and (e) matters relating to the payment of charge, including the following: (i) the time and manner of payment; (ii) pro‑rating, refunds, reduction, remission or waiving. (2) Despite section 14 of the Legislation Act 2003, the regulations may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other document: (a) as in force or existing at a particular time; or (b) as in force or existing from time to time; even if the instrument or other document does not exist when the regulations come into operation. (3) The regulations may provide for review of decisions under the regulations.