Queensland: Medicines and Poisons Act 2019 (Qld)

Medicines and Poisons Act 2019 An Act to regulate activities in relation to particular substances Chapter 1 Preliminary Part 1 Introduction 1 Short title This Act may be cited as the Medicines and Poisons Act 2019. 2 Commencement This Act commences on a day to be fixed by proclamation. Part 2 Purposes of Act 3 Main purposes The main purposes of this Act are as follows— (a) to ensure particular substances are made, sold, used and disposed of in an appropriate, effective and safe way; (b) to ensure health risks arising from the use of the substances are appropriately managed; (c) to ensure persons who are authorised to carry out activities using the substances have the necessary competencies to carry out the activities safely. 4 How main purposes are to be achieved The main purposes of this Act are to be achieved mainly by— (a) identifying particular activities and substances to be controlled; and (b) authorising classes of persons to use the substances in controlled ways for particular purposes; and (c) providing a scheme to authorise additional activities using the substances under approvals or licences; and (d) requiring persons authorised to use the substances to have competencies and be accountable for the safe and effective use of the substances; and (e) requiring particular things to be done to ensure the appropriate use, quality, safety and disposal of the substances at all stages, from manufacture to supply to the consumer and final disposal as waste; and (f) providing for compliance with this Act to be monitored and enforced. Part 3 Application and operation of Act 5 Act binds all persons (1) This Act binds all persons, including the State and, as far as the legislative power of the Parliament permits, the Commonwealth and the other States. (2) Nothing in this Act makes the State, the Commonwealth or another State liable to be prosecuted for an offence against this Act. 6 Relationship with other Acts This Act does not limit or otherwise affect the application of any of the following Acts— (a) the Agricultural and Veterinary Chemicals (Queensland) Act 1994; (b) the Agricultural Chemicals Distribution Control Act 1966; (c) the Chemical Usage (Agricultural and Veterinary) Control Act 1988; (d) the Drugs Misuse Act 1986; (e) the Public Health Act 2005; (f) the Radiation Safety Act 1999; (g) the Therapeutic Goods Act 2019. 7 Exemption for low-risk activities (1) An activity, of a type prescribed by regulation, with a substance is exempt from the operation of this Act. (2) The Minister may recommend to the Governor in Council the making of a regulation prescribing a type of activity under subsection (1) only if the Minister is satisfied the activity with the substance could reasonably be expected to pose no, or a negligible, health risk to any person. Part 4 Interpretation Division 1 Definitions generally 8 Definitions The dictionary in schedule 1 defines particular words used in this Act. 9 Relationship with Poisons Standard (1) Words and expressions defined in the Poisons Standard and used in this Act have the same meaning in this Act as they have in the Poisons Standard, to the extent the context permits. (2) An interpretation provision in the Poisons Standard applies for interpreting the words and expressions mentioned in subsection (1) for this Act. (3) Subsections (1) and (2) do not apply to the meaning of poison. (4) For this Act, a schedule of the Poisons Standard applies to a substance if— (a) the substance is listed in the schedule; and (b) the schedule does not exclude the substance from the schedule; and (c) if a restriction is mentioned in the Poisons Standard for the substance—the restriction applies in relation to the substance. Division 2 Substances 10 Meaning of substance (1) A substance includes an ingredient, compound, preparation or extract of a substance. (2) For this Act, a substance may be described by reference to any of the following matters— (a) the Poisons Standard; (b) a code, guideline, protocol or other standard; (c) the purpose for which the substance is, or is intended to be, used; (d) the way in which the substance is, or is intended to be, used; (e) the quantity of the substance; (f) the packaging or labelling of the substance; (g) the physical or chemical state or form of the substance. 11 Meaning of medicine (1) A medicine is— (a) a substance to which the Poisons Standard, schedule 2 applies (an S2 medicine); or (b) a substance to which the Poisons Standard, schedule 3 applies (an S3 medicine); or (c) a substance to which the Poisons Standard, schedule 4 applies (an S4 medicine); or (d) a substance to which the Poisons Standard, schedule 8 applies (an S8 medicine). (2) However, a substance mentioned in subsection (1) is not a medicine to the extent it is treated as a poison under section 12(2). (3) A regulation may prescribe another substance to be an S2, S3, S4 or S8 medicine. 12 Meaning of poison (1) A poison is any of the following substances, other than a fumigant or pesticide— (a) a substance to which the Poisons Standard, schedule 5 applies (an S5 poison); (b) a substance to which the Poisons Standard, schedule 6 applies (an S6 poison); (c) a substance to which the Poisons Standard, schedule 7 applies (an S7 poison). (2) A medicine is treated as a poison under this Act if the medicine is not used, or is not intended to be used, for a therapeutic use. Note— See the Poisons Standard, part 1 for the definition therapeutic use. (3) Subsection (2) does not apply to waste from a medicine disposed of because it is not required for a therapeutic use. (4) A regulation may prescribe another substance to be an S5, S6 or S7 poison. 13 Meaning of prohibited substance (1) A prohibited substance is— (a) a substance to which the Poisons Standard, schedule 9 applies (an S9 prohibited substance); or (b) a substance to which the Poisons Standard, schedule 10 applies (an S10 prohibited substance). (2) A regulation may prescribe another substance to be an S9 or S10 prohibited substance. 14 Meaning of fumigant and pesticide (1) A fumigant is a substance that is APVMA approved for use to carry out an activity of a type mentioned in section 19(2). (2) A pesticide is a substance that is APVMA approved for use to carry out an activity of a type mentioned in section 19(3). (3) A regulation may prescribe another substance to be a fumigant or pesticide. (4) In this section— APVMA approved, in relation to a use for a substance, means the substance is approved, registered or permitted for the use by the Australian Pesticides and Veterinary Medicines Authority in the exercise of a function or power under the Agvet Code of Queensland, section 21. 15 Meaning of S7 substance An S7 substance is— (a) an S7 poison; or (b) a fumigant or pesticide containing a substance to which the Poisons Standard, schedule 7 applies. 16 Meaning of hazardous poison A hazardous poison is— (a) an S7 substance; or (b) a medicine treated as a poison under section 12(2). 17 Meaning of regulated substance A regulated substance is a medicine, poison, prohibited substance, fumigant or pesticide. Division 3 Activities 18 Meaning of deals with a regulated substance A person deals with a regulated substance if the person does any of the following activities— (a) manufactures the substance; (b) buys the substance; (c) possesses the substance; (d) supplies the substance; (e) if the substance is a medicine— (i) administers the medicine; or (ii) prescribes or makes a standing order for the medicine; (f) if the substance is a poison—applies the poison; (g) if the substance is a prohibited substance—otherwise uses the substance; (h) disposes of waste from the substance; (i) asks or directs another person to do something mentioned in any of paragraphs (a) to (h). 19 Meaning of pest management activity , fumigation activity and pest control activity (1) A pest management activity is a fumigation activity or a pest control activity. (2) A person carries out a fumigation activity if the person prepares or uses a substance to do any of the following activities when the substance becomes gaseous— (a) kill a pest; (b) sterilise grain or seed to prevent germination; (c) treat soil in which pests might be living; (d) another activity prescribed by regulation. (3) A person carries out a pest control activity if the person prepares or uses a substance to do any of the following activities, other than a fumigation activity— (a) kill, repel or stupefy a pest; (b) inhibit the feeding of a pest; (c) modify the physiology of a pest to alter its natural development or reproductive capacity. 20 Meaning of regulated activity A regulated activity is— (a) a dealing with a regulated substance; or (b) a pest management activity or asking or directing another person to carry out a pest management activity. 21 Meaning of manufacture a regulated substance Manufacture, a regulated substance— (a) means carry out any activity using any substance for the purpose of making the regulated substance; and (b) includes any process or step undertaken to produce the regulated substance or to prepare the regulated substance for supply to the public or a person, including for administration to an animal. Examples for paragraph (b)— • testing batches of manufactured substances • compounding medicines in preparation for supply • repackaging poisons for supply 22 Meaning of buy a regulated substance Buy, a regulated substance, includes— (a) give a purchase order for the substance; and (b) otherwise attempt to obtain the substance, whether or not for consideration. Note— See also section 29 in relation to the distribution or transfer of regulated substances in workplaces. 23 Meaning of possess a regulated substance (1) Possess, a regulated substance, means have custody or control of the substance. (2) To remove any doubt, it is declared that a person may possess a regulated substance jointly with another person. Note— See also section 29 in relation to the distribution or transfer of regulated substances in workplaces. 24 Meaning of supply a regulated substance (1) Supply, a regulated substance, means sell or give the substance to a person. Note— See also section 25 in relation to particular ways of selling and giving regulated substances. (2) However, supply, a regulated substance, does not include— (a) if the substance is a medicine—administer the substance; or (b) if the substance is a poison—apply the substance; or (c) dispose of waste from the substance. Note— See also section 29 in relation to the distribution or transfer of regulated substances in workplaces. 25 Meaning of particular terms for supply (1) Sell, a regulated substance, includes attempt to sell the substance or make the substance available for sale. (2) Dispense, a medicine, means sell the medicine to a person on prescription. (3) Give a treatment dose, of a medicine, means give 1 or more doses of the medicine to a person to be taken by a particular person, or administered to an animal, at a later time. 26 Meaning of administer a medicine (1) Administer, a medicine, means— (a) introduce a dose of the medicine into the body of a person or animal by any means; or (b) give a dose of the medicine to a person to be taken immediately. Examples of administering a medicine— • injecting a medicine into the body of a person or animal • putting cream on the skin of a person or animal • putting drops into the eyes of a person or animal • handing a dose of tablets to a person for the person to swallow immediately • feeding an animal food that has a medicine mixed into it (2) However, administer, a medicine, does not include dispensing the medicine. 27 Meaning of apply a poison Apply, a poison, means add, apply, disperse, inject, spray or spread the poison. Examples of applying a poison— • cleaning an aluminium surface with a poison • electroplating metal using a solution containing a poison • adding a poison to another substance to create a chemical reaction • using a poison to calibrate or test a scientific or analytical instrument 28 Meaning of dispose of waste Dispose, of waste from a regulated substance, means discard, destroy or abandon the waste at a place. 29 Distribution or transfer in workplaces (1) This section applies if— (a) an entity is authorised to carry out a regulated activity with a regulated substance at 1 or more places; and (b) the regulated substance is distributed or transferred between workers for the entity at or between the places. (2) Despite sections 22 and 24, the distribution or transfer of the regulated substance is treated as possessing, rather than buying or supplying, the substance under this Act. Division 4 Authorisations 30 How a person is authorised under this Act (1) Under this Act, the following persons are authorised to carry out a regulated activity with a regulated substance— (a) an approved person; (b) a person acting under an emergency order; (c) the holder of a substance authority; (d) another person acting under a substance authority. Examples for paragraph (d)— • a person employed by the holder of a substance authority • a student or volunteer for the holder of a substance authority Notes— 1 See chapter 3, part 1, division 1 in relation to the authorisation of approved persons. 2 See chapter 3, part 1, division 2 in relation to the authorisation of persons under emergency orders. 3 See chapter 3, part 2, division 1 in relation to the authorisation of holders of substance authorities and other persons acting under substance authorities. (2) This Act authorises a person mentioned in subsection (1) only to the extent the person carries out the regulated activity with the regulated substance in the authorised way. 31 Meaning of authorised way A person carries out a regulated activity with a regulated substance in the authorised way if— (a) the person is authorised under section 54(4), 57 or 62 to carry out the regulated activity with the regulated substance; and (b) the person complies with any requirements prescribed for the person under section 91(1) for carrying out the regulated activity with the regulated substance; and (c) the person complies with any substance management plan that applies to the person. Note— Chapter 4, part 2 provides for substance management plans to be made for regulated places about dealings with regulated substances. Note— See also sections 60 and 74 for other persons who are taken to carry out particular regulated activities in the authorised way. Chapter 2 Offences Part 1 General offences Division 1 Regulated substances 32 Offence to deal with prohibited substances A person must not deal with a prohibited substance unless the person— (a) deals with the substance in the authorised way; or (b) has a reasonable excuse. Maximum penalty—750 penalty units. Examples of a reasonable excuse in relation to possessing a prohibited substance— 1 A health practitioner or employee working in a hospital receives a prohibited substance while treating a patient. 2 A person becomes responsible for the affairs of the holder of a substance authority who is critically ill, dies, is imprisoned or becomes bankrupt. 33 Offence to manufacture medicines or hazardous poisons A person must not manufacture a medicine or hazardous poison unless the person— (a) manufactures the medicine or poison in the authorised way; or (b) has a reasonable excuse. Maximum penalty—750 penalty units. 34 Offence to buy or possess S4 or S8 medicines or hazardous poisons (1) A person must not buy or possess an S4 or S8 medicine or hazardous poison unless the person— (a) buys or possesses the medicine or poison in the authorised way; or (b) has a reasonable excuse. Maximum penalty—200 penalty units. Example of a reasonable excuse— A person becomes responsible for the affairs of the holder of a substance authority who is critically ill, dies, is imprisoned or becomes bankrupt. (2) However, subsection (1) does not apply to a person to whom an S4 or S8 medicine is lawfully supplied for— (a) the person's own therapeutic treatment; or (b) the therapeutic treatment of someone else for whom the person is an agent; or (c) the treatment of an animal. (3) Also, subsection (1) does not apply to a person who— (a) is given an S4 or S8 medicine lawfully supplied for the therapeutic treatment of someone else or an animal; and (b) temporarily possesses the medicine until it is needed for the treatment. 35 Offence to supply medicines or hazardous poisons (1) A person (the supplier) must not supply a medicine or hazardous poison to someone else (the recipient) unless the supplier— (a) lawfully possesses the medicine or poison and supplies the medicine or poison in the authorised way; or (b) has a reasonable excuse. Maximum penalty—500 penalty units. (2) For subsection (1), the following matters are immaterial— (a) the quantity of the medicine or poison supplied; (b) whether or not the supplier and the recipient are in the same place when the medicine or poison is supplied; (c) whether or not the medicine or poison is supplied by indirect means. Division 2 Medicines Subdivision 1 Administration and supply generally 36 Offence to administer medicines A person must not administer a medicine to someone else or an animal unless the person— (a) administers the medicine in the authorised way; or (b) has a reasonable excuse. Maximum penalty—200 penalty units. 37 Offence to supply or administer animal medicines to humans (1) This section applies in relation to the following dealings with an animal medicine— (a) supplying the medicine to a person for human therapeutic use; (b) administering the medicine to a person; (c) self-administering the medicine. (2) A person must not deal with an animal medicine as mentioned in subsection (1) unless the person has a reasonable excuse. Maximum penalty—100 penalty units. (3) It is a reasonable excuse for the person to deal with the animal medicine because no other medicine is available to treat a human ailment, disease or injury. (4) In this section— animal medicine means a medicine— (a) manufactured or supplied for administration to an animal; or (b) labelled with an approved label stating the medicine is for administration to an animal. 38 Offence to prescribe or make standing orders A person must not prescribe, or make a standing order for, a medicine unless the person— (a) prescribes, or makes the standing order, for the medicine in the authorised way; or (b) has a reasonable excuse. Maximum penalty—200 penalty units. Subdivision 2 Particular substances 39 Unlawfully buying diversion-risk medicines (1) A person must not use a document the person has unlawfully prepared, or knows has been unlawfully prepared, for buying a diversion-risk medicine. Maximum penalty—100 penalty units. (2) A person must not, for buying a diversion-risk medicine, give someone who is authorised to prescribe or supply the medicine— (a) a statement the person knows is false or misleading in any way; or (b) a statement that omits anything without which it is false or misleading. Maximum penalty—100 penalty units. 40 Offences for self-prescribing or self-administering high-risk medicines (1) A person who is authorised to prescribe a high-risk medicine must not self-prescribe the medicine unless the person has a reasonable excuse. Maximum penalty—100 penalty units. Examples of a reasonable excuse— 1 A person who is authorised to prescribe a high-risk medicine is injured in an accident and asks someone to urgently administer a high-risk medicine that is an analgesia to the person. 2 A person who is authorised to prescribe a high-risk medicine self-prescribes the medicine because the person urgently needs it to avoid a break in the person's regular treatment for a seizure disorder. (2) A person who is authorised to deal with a high-risk medicine must not self-administer a dose of the medicine unless— (a) someone else who is authorised to prescribe the medicine has prescribed the medicine for the person's treatment; or (b) someone else who is authorised to give a treatment dose of the medicine has given the medicine to the person for the person's treatment; or (c) the person has a reasonable excuse. Maximum penalty—100 penalty units. (3) In this section— high-risk medicine means a medicine prescribed by regulation to be a high-risk medicine. 41 Requirement to check database for particular dealings with monitored medicines (1) This section applies to a relevant practitioner if— (a) the practitioner is authorised to prescribe a monitored medicine and proposes to prescribe the medicine for a person; or (b) the practitioner is authorised to dispense a monitored medicine and proposes to dispense the medicine for a person; or (c) the practitioner is authorised to give a treatment dose of a monitored medicine and proposes to give the treatment dose of the medicine to be taken by a person. (2) Before the proposed dealing happens, the relevant practitioner must check the monitored medicines database to see whether information recorded in the database shows that the person has previously been prescribed, dispensed or given any monitored medicine. Maximum penalty—20 penalty units. (3) Subsection (2) does not apply to the relevant practitioner if— (a) the proposed dealing happens in circumstances prescribed by regulation to be exempt from the subsection; or (b) the relevant practitioner has a reasonable excuse for not complying with the subsection. (4) In this section— relevant practitioner means a health practitioner prescribed by regulation to be a relevant practitioner for this section. 42 Offence to dispose of waste from diversion-risk medicines (1) A person must not dispose of waste from a diversion-risk medicine unless the person— (a) disposes of the waste in the authorised way; or (b) has a reasonable excuse. Maximum penalty—200 penalty units. (2) Subsection (1) does not apply to a person who— (a) discards the waste by placing it under the control of a person authorised to dispose of the waste under this Act; or Example for paragraph (a)— a person who returns the waste to a pharmacist for disposal in a 'return unwanted medicines' bin (b) discards or destroys the waste under another law. Example for paragraph (b)— the holder of an environmental authority under the Environmental Protection Act 1994 who destroys the waste in accordance with the authority Division 3 Poisons and pest management 43 Offence to apply poisons (1) This section applies in relation to a poison other than an S5 or S6 poison. (2) A person must not apply a poison unless the poison is lawfully supplied to the person and the person— (a) applies the poison in the authorised way; or (b) has a reasonable excuse. Maximum penalty—200 penalty units. 44 Offence to carry out pest management activities (1) A person must not carry out a pest management activity unless the person carries out the activity in the authorised way or has a reasonable excuse. Maximum penalty—200 penalty units. (2) Subsection (1) does not apply to a person who is any of the following— (a) a primary producer, or an agent of a primary producer, who carries out a pest control activity using a pesticide on land owned or occupied by the primary producer; Examples for paragraph (a)— • spraying pesticide on an agricultural crop using a motor vehicle with attached spray booms • spraying fruit using a pesticide to protect the fruit from damage by insects (b) a primary producer, or an agent of a primary producer, who carries out a fumigation activity using a fumigant on land owned or occupied by the primary producer; Example for paragraph (b)— sterilising soil by using a fumigant to prepare the soil for planting an agricultural crop (c) a person responsible for caring for or growing a plant who carries out a pest control activity using a pesticide on the plant at a place that is primarily used for horticultural, recreational or sporting activities; Examples for paragraph (c)— • spraying pesticide on trees at a nursery to prevent diseases • spraying a bowling green using a pesticide to protect it from damage by insects (d) a person who carries out a pest control activity using a household pesticide to control a pest, including a pest on an animal, if— (i) the activity is carried out— (A) at residential premises; or (B) incidentally when performing other activities at another place, using a minimal amount of the pesticide; and (ii) the activity is not carried out for a pest management business. Examples for paragraph (d)— • using a household pesticide to kill cockroaches at a house • using a household pesticide to control fleas and ticks on a dog • spraying a household pesticide on a water meter box in a nature strip before working on the box (3) Subsection (2) applies only if the fumigant or pesticide is used in accordance with the approved label of the fumigant or pesticide. (4) In this section— household pesticide means a pesticide ordinarily used in households and available to buy in a retail store. Examples— • bait for killing cockroaches available to buy at a supermarket • flea and tick treatment for dogs available to buy at a pet store primary producer, in relation to land, means a person using the land to commercially produce agricultural or horticultural products. 45 Offence to offer to carry out pest management activities if unauthorised A person must not offer to carry out a pest management activity for a pest management business unless— (a) the person has a pest management licence; or (b) the person employs someone else with a pest management licence to carry out the pest management activity. Maximum penalty—200 penalty units. 46 Offence to require or permit unauthorised persons to carry out pest management activities (1) This section applies to a person (a manager) who— (a) is authorised to carry out a pest management activity; or (b) operates a pest management business. (2) The manager must not permit or require another person to carry out a pest management activity for the manager if the manager knows the other person is not authorised to carry out the activity, unless the manager has a reasonable excuse. Maximum penalty—200 penalty units. 47 Offence to dispose of waste from hazardous poison, pesticide or fumigant (1) A person must not dispose of waste from a hazardous poison, pesticide or fumigant unless the person— (a) disposes of the waste in the authorised way; or (b) has a reasonable excuse. Maximum penalty—200 penalty units. (2) Subsection (1) does not apply to a person who— (a) discards the waste by placing it under the control of a person authorised to dispose of the waste under this Act; or Example for paragraph (a)— a person who returns the waste from a hazardous poison to a manufacturer of the poison for re-use (b) discards or destroys the waste under another law. Example for paragraph (b)— the holder of an environmental authority under the Environmental Protection Act 1994 who destroys the waste in accordance with the authority Division 4 Miscellaneous 48 Offence for giving or keeping false, misleading or incomplete information and records (1) This section applies to a person who— (a) gives information to the chief executive, whether orally or in a document— (i) for the purpose of obtaining or keeping an authorisation under this Act; or (ii) in response to a request for information under this Act; or (b) is required under this Act to keep a record. (2) The person must not— (a) give the chief executive information the person knows is false or misleading in a material particular; or (b) make or keep a record the person knows is false or misleading in a material particular; or (c) make or keep a record the person knows is incomplete in a material particular. Maximum penalty—50 penalty units. (3) Subsection (2)(a) does not apply to a person if the person, when giving information in a document— (a) tells the chief executive, to the best of the person's ability, how the document is false or misleading; and (b) if the person has, or can reasonably obtain, the correct information—gives the correct information. Part 2 Exclusions from offences and defences Division 1 Excluded persons 49 State officers and helpers (1) Subsection (2) applies to the following persons (each a State officer)— (a) an inspector or State analyst; (b) a health Act official; (c) a person employed within a part of the department known as Forensic and Scientific Services; (d) a police officer; (e) the Director of Forensic Science Queensland; (f) a staff member of Forensic Science Queensland. (2) A State officer does not commit an offence against this Act only because the State officer performs the officer's functions or exercises the officer's powers. (3) A person does not commit an offence against this Act if the person helps a State officer to perform the officer's functions or exercise the officer's powers. (4) In this section— health Act official means— (a) a health ombudsman official; or (b) a person appointed as an authorised person or security officer under the Hospital and Health Boards Act 2011; or (c) a person appointed as an authorised person or State analyst under the Public Health Act 2005. 50 Persons authorised under other laws (1) Subsection (2) applies to a person who has an approval, licence, permission or other authority (a related authority) under another Act or a law of the Commonwealth that permits the person to do something that is, or involves, carrying out a regulated activity with a regulated substance. Examples of related authorities— • an authority to aerially distribute an agricultural chemical under the Agricultural Chemicals Distribution Control Act 1966 • an approval under the Chemical Usage (Agricultural and Veterinary) Control Act 1988 • a licence under the Drugs Misuse Act 1986 • a licence under the Radiation Safety Act 1999 • a licence or permit under the Narcotic Drugs Act 1967 (Cwlth) • an approval, licence or permission under the Therapeutic Goods Act 1989 (Cwlth) (2) The person does not commit an offence against this Act to the extent the person acts under the related authority. (3) For subsection (2), if the person's related authority impliedly permits the person to possess a regulated substance without expressly stating that possession is permitted, the related authority is taken to permit possession of the regulated substance to the extent required to act under the related authority. (4) Also, a person does not commit an offence against this Act to the extent the person acts under an authorisation for the person under the Voluntary Assisted Dying Act 2021. 51 Agents and carers supplying or administering medicines (1) A person does not commit an offence against this Act if the person— (a) supplies a medicine by giving it to someone else (a patient) if the medicine has been lawfully supplied for the therapeutic treatment of the patient; or (b) for lawfully helping a patient, administers a medicine in accordance with the approved label of the medicine; or (c) administers a medicine to an animal in accordance with the approved label of the medicine. Examples of persons to whom subsection (1) applies— • a patient's family member who supplies a medicine to the patient in accordance with the medicine's dispensing label or packaging • a child's parent who administers a medicine to the child in accordance with the medicine's dispensing label or packaging • a dog's owner who administers a medicine to the dog in accordance with the medicine's approved label Note— Under section 34(2) and (3), persons in similar circumstances are also excluded from offences for buying or possessing S4 or S8 medicines. (2) However, subsection (1) does not apply to a person to the extent the person is authorised under this Act to supply or administer the medicine. Examples of persons to whom subsection (2) applies— • an approved person administering a medicine in the authorised way • a person to whom an emergency order applies (3) Also, subsection (1) does not apply to a person prescribed by regulation to be a person to whom the subsection does not apply. 52 Clinical trials (1) This section applies to a person who is permitted to deal with a regulated substance for a human clinical trial approved by a human research ethics committee. (2) The person does not commit an offence against this Act to the extent the person acts in accordance with any protocol or guidelines approved for the human clinical trial by the human research ethics committee. (3) In this section— human research ethics committee means a committee— (a) registered with the National Health and Medical Research Council established under the National Health and Medical Research Council Act 1992 (Cwlth), section 5B; and (b) operating in accordance with the human research guidelines issued under the National Health and Medical Research Council Act 1992 (Cwlth), section 10. Division 2 Defence provision 53 Defence for workers In a proceeding for an offence against a provision of this Act, it is a defence for a worker for an entity to prove that the entity did not provide the worker with suitable equipment, facilities, training or other resources that would have allowed the worker to comply with the provision. Note— See also section 214 in relation to the liability of executive officers of corporations. Chapter 3 Authorising regulated activities Part 1 Approved persons and emergency orders Division 1 Approved persons 54 Authorisation of prescribed classes of persons (1) A regulation may prescribe a class of persons to be authorised to carry out a regulated activity with a regulated substance. (2) Without limiting subsection (1), the regulated activity with the regulated substance for the class of persons may be prescribed by reference to— (a) the circumstances in which the regulated activity may be carried out by the class of persons; or (b) the purposes for which the regulated activity may be carried out by the class of persons; or (c) the direction or supervision under which the regulated activity may be carried out by the class of persons; or (d) an extended practice authority that applies to the class of persons. (3) An approved person is a member of a class of persons prescribed under subsection (1) for a regulated activity with a regulated substance for the class of persons. (4) Subject to section 30(2), the approved person is authorised to carry out the regulated activity with the regulated substance. Note— See, however, section 31 for when the approved person carries out the regulated activity with the regulated substance in the authorised way. (5) An authorisation under subsection (4) is an approved person's authorisation. (6) This section is subject to sections 55 and 56. 55 Changes to approved person's authorisation (1) This section applies in relation to an approved person if— (a) the chief executive takes administrative action in relation to the approved person's authorisation; or (b) the approved person is a health practitioner subject to a condition, notation or undertaking (each a condition) on the person's registration under the Health Practitioner Regulation National Law that relates to the approved person's authorisation; or (c) the approved person is a veterinary surgeon subject to a condition on the person's registration under the Veterinary Surgeons Act 1936. (2) The approved person's authorisation— (a) if the administrative action is suspension—ends for the period of the suspension; or (b) otherwise—is changed to the extent necessary to give effect to the administrative action or condition. Examples— 1 An approved person's authorisation authorises the person to deal with an S8 medicine. The chief executive takes administrative action to suspend the approved person's authorisation. The approved person's authorisation does not authorise the person to deal with the S8 medicine. 2 An approved person's authorisation authorises the person to deal with any S8 medicine. The approved person is subject to a condition under the Health Practitioner Regulation National Law stating the person must not deal with a particular S8 medicine. The approved person's authorisation does not authorise the person to deal with the particular S8 medicine. 56 Relationship between different authorisations (1) This section applies if— (a) an approved person's authorisation (the primary authorisation) relates to carrying out a regulated activity with a regulated substance; and (b) the approved person is authorised in another way under another provision of this Act (an alternative authorisation) in relation to the regulated activity with the regulated substance. Examples of when this section applies— 1 An approved person's authorisation does not authorise the person to prescribe an S8 medicine and the person holds a prescribing approval authorising the person to prescribe the S8 medicine in particular circumstances. 2 An approved person's authorisation authorises the person to apply an S7 substance, other than a particular poison, and the person holds a general approval authorising the person to apply the particular poison. (2) To the extent practicable, the primary authorisation and the alternative authorisation are to be read together. (3) However, if the primary authorisation is inconsistent with the alternative authorisation, the primary authorisation does not apply to the approved person to the extent of the inconsistency. Division 2 Emergency orders 57 Authorisation under emergency order Subject to section 30(2), a person is authorised to carry out a regulated activity with a regulated substance if the person is authorised under an emergency order to carry out the activity with the substance. Note— See, however, section 31 for when the person carries out the regulated activity with the regulated substance in the authorised way. 58 Chief executive may make emergency order (1) The chief executive may make an order (an emergency order) authorising a person to carry out a regulated activity with a regulated substance in relation to any of the following events— (a) a biosecurity event for which a biosecurity emergency order applies under the Biosecurity Act 2014, section 113; (b) a disaster situation under the Disaster Management Act 2003; (c) a declared public health emergency under the Public Health Act 2005; (d) an emergency under the Public Safety Preservation Act 1986; (e) another event, at a State or local level, that poses a health risk, including an event that has the potential to cause human disease through exposure to infection. Example for paragraph (e)— an outbreak of a communicable disease (2) An emergency order must state the following things— (a) the event to which the order applies; (b) a description of the area to which the order applies; (c) the day the order starts; (d) the day, no later than 3 months after the order starts, the order ends; (e) the regulated activity with the regulated substance that may be carried out; (f) the class of persons who may carry out the regulated activity; (g) any conditions applying to the regulated activity, including, for example, the circumstances in which a person may carry out the activity. 59 Publication of emergency order (1) The chief executive must, immediately after making the emergency order, take reasonable steps to ensure persons likely to be directly affected by the order are made aware of the order. Examples of taking reasonable steps— publishing media releases, contacting persons affected, advertising in newspapers or other publications (2) Also, the chief executive must publish the emergency order on the department's website as soon as practicable, but no later than 2 business days, after it is made. (3) An emergency order is not invalid only because of a failure of the chief executive to comply with subsection (1). Division 3 Miscellaneous 60 Authorisation for persons subject to work health and safety laws (1) A person is taken to deal with an S7 poison in the authorised way if the dealing is carried out— (a) at, or in connection with, a place that is subject to a work health and safety law; and (b) in the course of performing the person's duties at, or in connection with, the place; and (c) in compliance with the work health and safety law. (2) However, subsection (1) does not apply if— (a) the dealing is the manufacture or supply of an S7 poison; or (b) the S7 poison is an excluded S7 poison; or (c) the dealing is carried out at, or in connection with, an excluded place. (3) In this section— excluded place means— (a) any part of a place that is a person's residence or that is accessible by the general public; or (b) another place prescribed by regulation to be an excluded place for this section. excluded S7 poison means an S7 poison prescribed by regulation to be an excluded S7 poison for this section. resource authority see the Mineral and Energy Resources (Common Provisions) Act 2014, section 10. work health and safety law means— (a) the Work Health and Safety Act 2011; or (b) a provision of an Act relating to safely carrying out activities under a resource authority. Part 2 Authorisation under substance authorities Division 1 Preliminary 61 What is a substance authority A substance authority is— (a) a manufacturing licence; or (b) a wholesale licence; or (c) a retail licence; or (d) a pest management licence; or (e) a prescribing approval; or (f) a general approval. 62 Authorisation under substance authority Subject to section 30(2), a person is authorised to carry out a regulated activity with a regulated substance if the person— (a) is the holder of a substance authority that authorises the holder to carry out the activity; or (b) is stated, or is a member of a class of persons stated, to be authorised under the authority to carry out the activity. Examples for paragraph (b)— • a person employed by the holder of a substance authority • a student or volunteer for the holder of a substance authority Note— See, however, section 31 for when the person carries out the regulated activity with the regulated substance in the authorised way. Division 2 Types of substance authorities 63 What is a manufacturing licence (1) A manufacturing licence is a licence that authorises a person to carry out the following regulated activities with a regulated substance stated in the licence— (a) manufacture of the regulated substance at a place stated in the licence; (b) possession of the regulated substance at a place stated in the licence; (c) possession of the regulated substance for transportation to a place where a person is authorised, or where it is not unlawful for a person, to possess the substance; (d) supply of the regulated substance, primarily by wholesale, to— (i) if the licence states a class of persons to whom the substance may be supplied—a person who is a member of the class; or (ii) otherwise—a person who is authorised, or for whom it is not unlawful, to carry out a regulated activity with the substance; (e) disposal of waste from the regulated substance. (2) A manufacturing licence may, if stated in the licence, authorise— (a) the buying and possession of another stated regulated substance for manufacturing the regulated substance to be manufactured under the licence (the final product); or (b) the manufacture of, and disposal of waste from, another stated regulated substance that is a by-product of the manufacture of the final product. 64 What is a wholesale licence A wholesale licence is a licence that authorises a person to carry out the following regulated activities with a regulated substance stated in the licence— (a) buying stock of the regulated substance; (b) possession of the regulated substance at a place stated in the licence; (c) possession of the regulated substance for transportation to a place where a person is authorised, or where it is not unlawful for a person, to possess the substance; (d) supply of the regulated substance, primarily by wholesale, to— (i) if the licence states a class of persons to whom the substance may be supplied—a person who is a member of the class; or (ii) otherwise—a person who is authorised, or for whom it is not unlawful, to carry out a regulated activity with the regulated substance; (e) disposal of waste from the regulated substance. 65 What is an S2 retail licence or an S7 retail licence (1) An S2 retail licence is a licence that authorises a person to carry out the following regulated activities with an S2 medicine stated in the licence— (a) buying stock of the medicine; (b) selling the medicine by retail at a place stated in the licence. (2) An S7 retail licence is a licence that authorises a person to carry out the following regulated activities with an S7 substance stated in the licence— (a) buying stock of the substance; (b) possession of the substance at a place stated in the licence; (c) possession of the substance for transportation to a place where a person is authorised, or where it is not unlawful for a person, to possess the substance; (d) selling the substance by retail to— (i) if the licence states a class of persons to whom the substance may be sold—a person who is a member of the class; or (ii) otherwise—a person who is authorised, or for whom it is not unlawful, to carry out a regulated activity with the substance; (e) disposal of waste from the substance. 66 What is a pest management licence A pest management licence is a licence that authorises a person to carry out the pest management activities stated in the licence using a fumigant or pesticide stated in the licence. 67 What is a prescribing approval A prescribing approval is an approval that authorises a person to carry out any of the following regulated activities with a medicine stated in the approval— (a) prescribing the medicine for a person, or a class of persons, stated in the approval in the stated circumstances; (b) buying, possessing, administering, dispensing and giving a treatment dose of the medicine in the stated circumstances. 68 What is a general approval (1) A general approval is an approval that authorises a person to carry out a regulated activity with a regulated substance stated in the approval. (2) A regulation may prescribe different classes of general approvals for carrying out different types of regulated activities. Division 3 Duration and conditions of substance authorities 69 Duration A substance authority remains in force for the term decided by the chief executive and stated in the authority, unless sooner suspended, cancelled or surrendered. 70 Conditions (1) A substance authority is subject to— (a) a condition (a standard condition) prescribed by regulation to apply in relation to the substance authority; and (b) any additional condition decided by the chief executive under part 3. Examples of standard conditions— Conditions stating— • how to test batches of regulated substances during manufacturing; or • how a person must dispose of waste from a regulated substance; or • when and how the holder of a substance authority must advise the chief executive of changes to the holder's circumstances (2) If the chief executive decides to change a standard condition under part 3, the substance authority is subject to the changed condition instead of the standard condition. (3) For subsection (1), the regulation may prescribe a standard condition for a substance authority by reference to a code, guideline, protocol or standard, including a departmental standard. 71 Failure to comply with substance authority conditions A person to whom a substance authority applies must comply with the conditions of the authority unless the person has a reasonable excuse. Maximum penalty—200 penalty units. Division 4 Changes of circumstances 72 Transfer unavailable (1) A substance authority can not be transferred. (2) If the sole holder of a substance authority dies, the authority is cancelled. 73 Changes affecting substance authority (1) This section applies if the holder of a substance authority notifies the chief executive of a change in circumstances in relation to the authority. (2) The chief executive may require the holder to apply to amend the substance authority in a stated way, or apply for a new substance authority, by a stated reasonable day. (3) The chief executive must give the holder an information notice for the decision to make a request under subsection (2). (4) The substance authority is cancelled— (a) if the holder does not comply with the request before the stated day—on the stated day; or (b) if the holder applies for a new substance authority—on the day the application is decided. 74 Finalising a substance authority (1) This section applies if a person stops being the holder of a substance authority. Example— The holder of a manufacturing licence surrenders the licence. (2) The chief executive may give the person a notice authorising the person to carry out a stated regulated activity with the regulated substance in a stated way for a stated period. Example of a notice— A notice states that a person who has surrendered a manufacturing licence for S7 poisons may store the poisons at the place where the poisons were manufactured for 6 months until the poisons can be taken to a disposal facility. (3) The person is taken to carry out the regulated activity with the regulated substance in the authorised way if the person complies with the notice. Part 3 Applications for substance authorities Division 1 Initial applications 75 Requirements for making initial application An application for a substance authority (an initial application) must— (a) be made to the chief executive; and (b) be in the approved form; and (c) be accompanied by the fee prescribed by regulation; and (d) if the application is for a pest management licence—be made by an individual of at least 17 years. 76 Deciding initial application (1) The chief executive must decide whether or not to grant the initial application. (2) In considering the initial application, the chief executive may have regard to any of the following matters— (a) the need for, and the safety and efficacy of, the regulated activity with the regulated substance proposed in the application; (b) whether a relevant person is a fit and proper person for the substance authority applied for; Note— See section 216 for when the chief executive may seek criminal history information about a relevant person. (c) any standard conditions for the substance authority for which the application is made; Note— See section 70 in relation to standard conditions. (d) whether the place at which the regulated activity is proposed to be carried out is suitable for the activity; (e) if a substance management plan is required under section 93(1) for the place—whether a plan has been prepared; (f) if the application is for a pest management licence—a health assessment under section 90. (3) If the initial application relates to matters stated in a competency standard, the chief executive must have regard to the competency standard when considering the application. (4) If the chief executive decides to grant the initial application, the chief executive may also decide to take either of the following actions if the chief executive is satisfied the action is reasonably necessary— (a) impose additional conditions on the substance authority; (b) change a standard condition. Note— See section 70(2) for the effect of changing a standard condition. (5) In this section— competency standard means a departmental standard stating training and competency requirements for a person carrying out a regulated activity with a regulated substance. Note— See also division 4 in relation to the chief executive's consideration of applications. 77 Notice about decision (1) If the chief executive decides to grant the initial application without imposing additional conditions or changing any standard conditions, the chief executive must give the applicant a notice stating— (a) that the substance authority is granted; and (b) the day the decision takes effect; and (c) that the standard conditions apply to the substance authority. (2) If the chief executive decides to grant the initial application subject to additional conditions or changes to any standard conditions, or decides to refuse to grant the application, the chief executive must give the applicant an information notice for the decision. Division 2 Amendments of substance authorities 78 Requirements for making amendment application (1) The holder of a substance authority may apply (an amendment application) to the chief executive to amend the authority. (2) The amendment application must— (a) be made to the chief executive; and (b) be in the approved form; and (c) be accompanied by the fee prescribed by regulation. 79 Deciding amendment application (1) The chief executive must decide whether or not to grant the amendment application. (2) In considering the amendment application, the chief executive may have regard to— (a) the conditions of the substance authority; and (b) any changes to the matters considered by the chief executive when the substance authority was granted. Note— See also division 4 in relation to the chief executive's consideration of applications. 80 Notice about decision (1) If the chief executive decides to grant the amendment application, the chief executive must give the applicant a notice stating— (a) the amendment for the substance authority; and (b) the day the decision takes effect. (2) If the chief executive decides to refuse to grant the amendment application, the chief executive must give the applicant an information notice for the decision. 81 Minor amendment by chief executive (1) The chief executive may decide to amend a substance authority, without an application by the holder of the authority, if the amendment is only for— (a) a formal or clerical reason; or (b) another reason that does not adversely affect the interests of the holder. (2) As soon as practicable after the chief executive decides to make the amendment, the chief executive must give the holder a notice stating the amendment and the reason for the amendment. Division 3 Renewal applications 82 Requirements for making renewal application (1) The holder of a substance authority may apply (a renewal application) to the chief executive to renew the authority unless the authority states it must not be renewed. (2) The renewal application must— (a) be made to the chief executive; and (b) be in the approved form; and (c) be accompanied by the fee prescribed by regulation; and (d) be made within the period starting 90 days before the term of the substance authority ends. (3) Despite subsection (2)(d), the chief executive may accept a renewal application for a substance authority made within 30 days after the term of the authority ends if the chief executive is satisfied it is reasonable to accept the application in the circumstances. (4) If the chief executive accepts the renewal application, the substance authority is taken to have authorised the carrying out of the regulated activity with the regulated substance stated in the authority for the period between— (a) the day the authority ended; and (b) the day the chief executive accepted the application. Note— See section 85 about a substance authority being in force while a renewal application is considered. 83 Deciding renewal application (1) The chief executive must decide whether or not to grant the renewal application. (2) In considering the renewal application, the chief executive may have regard to— (a) the conditions of the substance authority; and (b) any changes to the matters considered by the chief executive when the substance authority was granted. Note— See also division 4 in relation to the chief executive's consideration of applications. (3) If the chief executive decides to grant the renewal application, the chief executive may also decide to take either of the following actions if the chief executive is satisfied the action is reasonably necessary— (a) impose additional conditions on the substance authority; (b) change a condition of the substance authority, including a standard condition. Note— See section 70(2) for the effect of changing a standard condition. 84 Notice about decision (1) If the chief executive decides to grant the renewal application without imposing additional conditions or changing any conditions, the chief executive must give the applicant a notice stating— (a) that the substance authority is renewed; and (b) the day the decision takes effect; and (c) the conditions that apply to the substance authority. (2) If the chief executive decides to grant the renewal application subject to additional conditions or changes to any conditions, or decides to refuse to grant the application, the chief executive must give the applicant an information notice for the decision. 85 Substance authority in force while renewal application considered (1) A substance authority subject to a renewal application continues in force from the day the renewal application is accepted by the chief executive until the application is decided or taken to have been withdrawn under division 4. (2) However, if the application is refused, or taken to be refused, the substance authority continues in force until an information notice for the refusal is given to the applicant. (3) This section does not apply if the substance authority is earlier suspended or cancelled under chapter 4, part 3. Division 4 Considering applications Subdivision 1 Preliminary 86 Definitions for division In this division— application means each of the following applications made under this part— (a) an initial application; (b) an amendment application; (c) a renewal application. final consideration day, for an application, means the day that is 90 days after— (a) if the chief executive gives the applicant a notice under section 87(1)—the day the chief executive receives the further information stated in the notice; or (b) if the chief executive gives the applicant more than 1 notice under section 87(1)—the day the chief executive receives the further information stated in the last notice; or (c) otherwise—the day the chief executive receives the application. Subdivision 2 Further information requests and period for deciding applications 87 Further information request (1) The chief executive may give an applicant a notice within 90 days after the chief executive receives the applicant's application stating further information the chief executive considers is reasonably required from the applicant to decide the app