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 for a scheme to—

(i)authorise additional activities using the substances under approvals or licences; and

(ii)restrict the grant of approvals or licences for inappropriate purposes; 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—

1See chapter 3, part 1, division 1 in relation to the authorisation of approved persons.

2See chapter 3, part 1, division 2 in relation to the authorisation of persons under emergency orders.

3See 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—

1A health practitioner or employee working in a hospital receives a prohibited substance while treating a patient.

2A 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—

1A 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.

2A 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—

1An 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.

2An 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—

1An 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.

2An 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 1A Restrictions on granting applications

86A   Authorisation for drug checking not permitted

(1)Despite another provision of this part, the chief executive must not grant an application to the extent the grant would authorise a person to deal with a regulated substance for the purpose of drug checking.

(2)In this section—

drug checking—

(a)means analysing a regulated substance to identify its ingredients if the substance—

(i)has been manufactured or possessed unlawfully or contains unknown ingredients; and

(ii)is provided for analysis by a member of the public; but

Example for paragraph (a)—

pill testing at a music festival

(b)does not include analysing a regulated substance to—

(i)exercise a power or perform a function under an Act; or

(ii)detect, investigate, prevent or prosecute an offence; or

(iii)monitor compliance with a condition of employment; or

(iv)monitor compliance with the rules of a sporting or racing competition; or

(v)provide therapeutic treatment to a person or treat an animal; or

(vi)detect a biosecurity risk or an environmental contaminant; or

(vii)undertake general research; or

(viii)carry out another activity prescribed by regulation.

general research—

(a)means research about a matter relating to a regulated substance that has been manufactured or possessed unlawfully or contains unknown ingredients; but

(b)does not include research that involves directly advising a particular person about the ingredients of, or risks associated with, a particular regulated substance possessed by the person.

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 application.

(2)The notice must state a reasonable period, of at least 30 days after the day the notice is given, for compliance with the notice.

(3)The further information must be verified by statutory declaration if required by the notice.

(4)The applicant is taken to have withdrawn the application if the applicant does not comply with the notice.

88   Agreement to extend period for decision

(1)The chief executive and an applicant may, at any time before the final consideration day for the applicant’s application, agree on a later day by which the application is to be decided.

(2)The chief executive must give the applicant notice of the day agreed under subsection (1).

89   Period for deciding application

(1)The chief executive must decide an application—

(a)if the day by which the application must be decided has been extended by agreement under section 88—on or before the agreed day; or

(b)otherwise—on or before the final consideration day for the application.

(2)Subsection (3) applies if the chief executive has asked, under section 216, for a criminal history report about a relevant person in relation to the application.

(3)The day by which the application must be decided under subsection (1) is extended by the number of days it takes for the criminal history report to be given to the chief executive after the chief executive asks for the report.

(4)The chief executive is taken to have refused to grant the application if the chief executive fails to decide the application by the day required under this section.

(5)The applicant is entitled to be given an information notice for the deemed refusal.

Subdivision 3 Health assessments

90   Health assessment for pest management licences

(1)This section applies in relation to an application for a pest management licence.

(2)The chief executive may ask the applicant to undergo an assessment (a health assessment) by a medical practitioner of the applicant’s physical and mental health.

Example—

The chief executive may decide a health assessment is necessary for considering an application for a pest management licence to work with fumigants in enclosed spaces.

(3)The chief executive must give the applicant a notice stating the following matters—

(a)the reason for requesting the health assessment;

(b)the name of a particular medical practitioner, or the qualifications of a medical practitioner, who may conduct the assessment;

(c)the reasonable day by which the assessment must be done.

(4)The assessment conducted by the medical practitioner must include a written report stating the practitioner’s findings about the applicant’s physical and mental health in relation to carrying out the type of regulated activity to which the application relates.

(5)If the applicant fails to give the written report to the chief executive by the day stated in the notice under subsection (3)(c), without a reasonable excuse, the applicant is taken to have withdrawn the application.

Chapter 4    Managing regulated activities

Part 1    Requirements for carrying out regulated activities in the authorised way

91   Requirements may be prescribed

(1)A regulation may prescribe requirements for a person, or a class of persons, authorised under section 54(4), 57 or 62 in relation to carrying out a type of regulated activity with a regulated substance.

Note—

Under section 31, a person mentioned in subsection (1) must comply with the requirements prescribed for the person to carry out a regulated activity with a regulated substance in the authorised way.

(2)Without limiting subsection (1), a requirement may do 1 or more of the following things—

(a)state the way a regulated activity must be carried out;

(b)require a person to comply with a departmental standard;

(c)require a person to comply with another code, guideline, protocol or standard;

(d)require a person to notify the chief executive if particular things happen in relation to a regulated activity or regulated substance.

(3)A requirement prescribed under subsection (1) is subject to—

(a)for an approved person—sections 55 and 56; or

(b)for a person to whom an emergency order applies—the emergency order; or

(c)for a person to whom a substance authority applies—any conditions of the authority.

Part 2    Substance management plans

92   Definitions for part

In this part—

regulated place means a place—

(a)where a dealing happens, or is proposed to happen, with a regulated substance; and

(b)prescribed by regulation to be a regulated place.

responsible person, for a regulated place, means the person prescribed by regulation to be the responsible person for the regulated place.

substance management plan, for a regulated place, means a document setting out how known and foreseeable risks associated with any dealing with a regulated substance are to be managed at, or in connection with, the regulated place.

Examples of risks associated with dealings with regulated substances—

1The quality of a regulated substance is compromised during production.

2A regulated substance is used in an inappropriate way.

3An unauthorised person gains access to a regulated substance.

93   Requirements for substance management plan

(1)The responsible person for a regulated place must make a substance management plan for the place that complies with subsection (2) before any dealing happens with a regulated substance at the place, unless the person has a reasonable excuse.

Maximum penalty—250 penalty units.

Example—

Before buying substances to manufacture a regulated substance at a regulated place under a manufacturing licence, the responsible person must make a substance management plan for the place.

(2)The substance management plan for the regulated place must—

(a)state the following matters—

(i)the day the plan starts;

(ii)the location of the place;

(iii)the dealings and regulated substances to which the plan applies;

(iv)the persons (staff) to whom the plan applies; and

(b)address the matters prescribed by regulation; and

(c)be written in a way that is likely to be easily understood by staff.

(3)The responsible person must ensure the substance management plan—

(a)is made available to staff when it is made; and

(b)is reviewed at the time prescribed by regulation.

Maximum penalty—250 penalty units.

(4)In a proceeding for an offence against subsection (3), it is a defence for the responsible person to prove the person took reasonable steps to comply with the subsection.

94   Compliance with substance management plan

A person stated in a substance management plan under section 93(2)(a)(iv) must comply with the plan, unless the person has a reasonable excuse.

Maximum penalty—200 penalty units.

Part 3    Administrative action

Division 1 Preliminary

95   Definitions for part

In this part—

administrative action, in relation to an authority, means action—

(a)changing a condition of an authority; or

(b)suspending an authority for a stated period or indefinitely; or

(c)cancelling a substance authority.

agreed administrative action see section 103(3).

authority means a substance authority or an approved person’s authorisation.

condition, of an approved person’s authorisation, means—

(a)the circumstances in which, or purposes for which, the approved person is authorised under section 54(4); or

(b)a requirement prescribed under section 91(1) for the approved person in relation to carrying out a regulated activity with a regulated substance.

holder, of an authority, means—

(a)for a substance authority—the entity granted the substance authority; or

(b)for an approved person’s authorisation—the approved person.

review day, for administrative action, means the earliest day on which the chief executive is required under this part to consider ending or changing the administrative action.

show cause notice see section 97(2).

show cause period see section 97(2)(d).

Division 2 Taking administrative action generally

96   Grounds for taking action

(1)The chief executive may take administrative action in relation to an authority if the chief executive believes—

(a)a relevant person for the authority has contravened a requirement under this Act or a corresponding law; or

(b)the administrative action is reasonably necessary to prevent or minimise a health risk; or

(c)a relevant person for the authority is not a fit and proper person; or

Note—

See section 216 for when the chief executive may seek criminal history information about a relevant person.

(d)a relevant person for the authority has made a materially false or misleading representation to obtain the authority.

(2)However, the chief executive may take administrative action under this section only if the chief executive has considered giving a compliance notice to the person about the matter to which the proposed administrative action relates.

97   Show cause notice before taking action

(1)This section applies if the chief executive is proposing to take administrative action in relation to an authority under section 96.

(2)The chief executive must first give the holder of the authority a notice (a show cause notice) stating—

(a)that the chief executive proposes to take the administrative action; and

(b)the proposed administrative action, including whether it applies to—

(i)all regulated activities with regulated substances to which the authority relates; or

(ii)a particular regulated activity or regulated substance; and

(c)the reasons for the proposed administrative action; and

(d)that the holder may, within a stated period of at least 21 days (the show cause period), give the chief executive a written response to the show cause notice.

98   Chief executive must consider response

(1)This section applies if the holder of the authority, within the show cause period, gives the chief executive a written response to the show cause notice.

(2)The chief executive must consider the written response before deciding whether or not to take the proposed administrative action stated in the show cause notice.

99   Decision not to take administrative action

If the chief executive decides not to take the proposed administrative action stated in the show cause notice, the chief executive must give the holder notice of the decision.

100   Decision to take administrative action

(1)This section applies if—

(a)the show cause period has ended; and

(b)the chief executive has considered any written response from the holder of the authority; and

(c)the chief executive believes there is a ground for taking administrative action.

(2)The chief executive may decide—

(a)to take the administrative action stated in the show cause notice; or

(b)to take other administrative action that is less onerous.

(3)If the chief executive decides to take administrative action to suspend the authority indefinitely or change the conditions of the authority, the chief executive must also decide the review day for the administrative action.

(4)The chief executive must give the holder an information notice for a decision under subsection (2) or (3).

(5)The administrative action takes effect on the day stated in the information notice.

(6)The day stated in the information notice under subsection (5) must not be earlier than the day the notice is given to the holder.

Division 3 Immediate or agreed administrative action

101   Application of division

(1)This division applies in relation to taking administrative action despite another division of this part.

(2)Each section of this division applies even if the chief executive has started, but not completed, the process for making a decision under another section of this division.

102   Immediate administrative action

(1)The chief executive may decide to take administrative action in relation to an authority on a ground mentioned in section 96(1) without giving the holder of the authority a show cause notice.

(2)However, subsection (1) applies only if the chief executive considers it is reasonably necessary to take the administrative action immediately because there is an urgent need to prevent a serious health risk to any person, including to the holder.

(3)If the chief executive decides to take administrative action to suspend an authority indefinitely or change the conditions of an authority, the chief executive must also decide the review day for the administrative action.

(4)The chief executive must give the holder an information notice for a decision under subsection (1) or (3).

(5)The administrative action takes effect on the day stated in the information notice.

(6)The day stated in the information notice under subsection (5) must not be earlier than the day the notice is given to the holder.

103   Agreed administrative action

(1)The chief executive may take administrative action in relation to an authority, other than cancellation of the authority, if a relevant person for the authority to whom the action applies agrees to the action being taken.

Example of agreeing to an action—

An approved person agrees to an indefinite suspension of the approved person’s authorisation.

(2)However, if the authority is a substance authority, the chief executive may take the administrative action only if the holder of the authority also agrees to the action.

(3)Action taken under subsection (1) is agreed administrative action.

(4)The chief executive and the relevant person must agree to a review day for the administrative action.

(5)The chief executive must give the holder a notice stating—

(a)the terms of the agreed administrative action; and

(b)the review day that has been agreed by the relevant person for the administrative action.

(6)The administrative action takes effect on the day stated in the notice.

(7)The day stated in the notice under subsection (6) must not be earlier than the day the notice is given to the holder.

Division 4 Reviewing administrative action

104   Application of division

This division does not apply in relation to administrative action that is the cancellation of a substance authority.

105   Request by holder to review administrative action

(1)The holder of an authority in relation to which administrative action has been taken may—

(a)ask the chief executive, in writing, to review the administrative action; and

(b)give the chief executive information supporting the holder’s request under paragraph (a).

(2)However, the holder may make a request under subsection (1) only on or after the review day for the administrative action.

106   Decision after reviewing administrative action on request

(1)The chief executive must consider a request made under section 105 and decide whether to—

(a)end the administrative action; or

(b)continue the administrative action (further administrative action); or

(c)take other administrative action in relation to the authority that is less onerous (also further administrative action).

(2)However, if the administrative action being considered is agreed administrative action, the chief executive may take further administrative action (further agreed action) only if—

(a)the relevant person to whom the further administrative action applies agrees to the action; and

(b)if the authority is a substance authority—the holder of the authority agrees to the further administrative action.

(3)If the chief executive decides to take further administrative action that is the suspension of the authority indefinitely or changing the conditions of the authority, the chief executive must also decide the review day for the further administrative action.

(4)If the chief executive decides to end the administrative action, or decides to take further agreed action, the chief executive must give the holder notice of the decision.

(5)If subsection (4) does not apply, the chief executive must give the holder an information notice for the decision.

107   Review of administrative action by chief executive

(1)The chief executive may decide to review administrative action taken in relation to an authority (the original action)—

(a)whether or not a request for the review of the original action has been made by the holder of the authority; and

(b)whether or not the decision is made before the review day for the original action.

(2)However, the review must be on a ground mentioned in section 96(1).

(3)If the chief executive proposes to change or continue the original action, the chief executive must give the holder of the authority a show cause notice.

(4)Sections 97 to 100 apply in relation to the show cause notice as if—

(a)the original action had not been taken; and

(b)the proposed change or continuation of the original action were the proposed administrative action to be taken under the sections.

(5)If the chief executive decides to end the administrative action, the chief executive must give the holder notice of the decision.

Part 4    Compliance notices

108   Giving a compliance notice

(1)This section applies if the chief executive or an inspector believes—

(a)a person has contravened a provision of this Act in circumstances that make it likely the contravention will continue or be repeated; and

(b)a matter relating to the contravention is reasonably capable of being rectified; and

(c)it is appropriate to give the person an opportunity to rectify the matter.

(2)The chief executive or inspector may give the person a notice (a compliance notice) requiring the person to rectify the matter.

109   Content of compliance notice

The compliance notice must state the following matters—

(a)that the chief executive or inspector believes the person has contravened a provision of this Act in circumstances that make it likely the contravention will continue or be repeated;

(b)the provision the chief executive or inspector believes has been contravened;

(c)briefly, how it is believed the provision has been contravened;

(d)the matter relating to the contravention that the chief executive or inspector believes is reasonably capable of being rectified;

(e)the reasonable steps the person must take to rectify the matter;

(f)that the person must take the steps within a stated period that is reasonable, having regard to any health risks posed by the contravention;

(g)that it is an offence to fail to comply with the compliance notice unless the person has a reasonable excuse.

110   Failure to comply with compliance notice

A person given a compliance notice must comply with the notice unless the person has a reasonable excuse.

Maximum penalty—200 penalty units.

Chapter 5    Monitoring and enforcement

Part 1    Special powers

Division 1 Emerging risk declarations

111   What is an emerging risk declaration

An emerging risk declaration is a declaration made by the chief executive declaring 1 or more of the following in relation to a substance that is not a regulated substance—

(a)the substance must not be made, sold or used in the State;

(b)the substance may be used only in a particular device or in a particular way;

(c)a particular device must not be used with the substance;

(d)the substance must be disposed of in a particular way.

112   Making emerging risk declaration

(1)The chief executive may make an emerging risk declaration in relation to a substance that is not a regulated substance if the chief executive believes—

(a)the substance is being made, sold or used in the State, including by using a device; and

(b)there is an urgent need to regulate, or further regulate, the substance under this Act because of a health risk.

(2)However, the chief executive may not make an emerging risk declaration in relation to a medical device under the Therapeutic Goods Act 1989 (Cwlth).

(3)The emerging risk declaration may state particular conditions that apply to carrying out an activity with the substance, including conditions about using particular devices, if the chief executive is satisfied the conditions are reasonably necessary to prevent or minimise a health risk.

113   Matters to be included in emerging risk declaration

(1)The emerging risk declaration must state—

(a)a description of the substance to which the declaration applies; and

(b)if the declaration relates to a device—

(i)a description of the device; and

(ii)either—

(A)a description of the particular way the device may or may not be used with the substance; or

(B)a statement that the device must not be used with the substance; and

(c)any conditions that apply to carrying out an activity with the substance.

(2)Also, the emerging risk declaration may state a day on which it takes effect and a day on which it ends.

114   Publication of emerging risk declaration

(1)The chief executive must—

(a)publish the emerging risk declaration on the department’s website; and

(b)take reasonable steps to ensure persons likely to be directly affected by the declaration are made aware of it.

Examples of taking reasonable steps—

publishing media releases, contacting persons affected, advertising in newspapers or other publications

(2)An emerging risk declaration is not invalid only because of a failure of the chief executive to comply with subsection (1).

115   Effect and duration of emerging risk declaration

(1)The emerging risk declaration takes effect—

(a)when the declaration is published on the department’s website; or

(b)if the declaration states a later day it takes effect—on the later day.

Note—

Section 128 states the process for applying for compensation for an emerging risk declaration.

249   Manufacturing licences for medicated animal feed

(1)This section applies to an HDPR approval that, immediately before the commencement, was a restricted drug manufacturer licence authorising the manufacture of medicated animal feed.

(2)On the commencement, the HDPR approval is taken to be a manufacturing licence authorising the manufacture of the medicated animal feed—

(a)with each substance that was approved under the HDPR approval; and

(b)under the supervision of the person responsible for supervising the manufacture under the HDPR approval; and

(c)at the place that was approved for manufacturing the feed under the HDPR approval; and

(d)for the term of the HDPR approval.

(3)To remove any doubt, it is declared that no conditions of the HDPR approval, other than those mentioned in subsection (2), apply to the manufacturing licence.

(4)This section applies despite sections 246 to 248.

250   Approvals for drug dependent persons

(1)This section applies to an HDPR approval that, immediately before the commencement, authorised the treatment of a drug dependent person, or class of drug dependent persons, under the HDPR, section 120, 122, 213 or 213A.

(2)The HDPR approval continues in effect until the earliest of the following—

(a)the day the term of the approval ends under the HDPR;

(b)the day the approval is cancelled or surrendered under the HDPR;

(c)the day prescribed under section 281 to be the day the monitored medicines database is fully operational.

(3)The HDPR continues to apply to the HDPR approval as if this Act had not commenced.

(4)This section applies despite sections 246 to 248.

251   Authorised way for continued approvals

A person who holds an HDPR approval or pest licence continued in effect under this part is taken to carry out a regulated activity with a regulated substance in the authorised way if the person carries out the activity under the HDPR or Pest Management Act, as the case may be.

252   Waiving fees for continued approvals

(1)This section applies if—

(a)a person holds an HDPR approval or pest licence continued in effect under this part; and

(b)before the term of the approval or licence ends, the person applies for a substance authority equivalent to the approval.

(2)The chief executive may decide to waive a fee, or part of a fee, payable under this Act for the application.

Subdivision 3 HDPR authorities

253   Royal Flying Doctor Service

(1)This section applies in relation to an HDPR authority that, immediately before the commencement, authorised a person from the Royal Flying Doctor Service of Australia to carry out an activity with a substance under the HDPR, section 54(1) or 157(1).

(2)The HDPR authority continues in effect as if this Act had not commenced until—

(a)if, within 1 year after the commencement, an appropriately qualified officer of the Royal Flying Doctor Service of Australia applies for a substance authority equivalent to the HDPR authority—the day the application for the substance authority is decided; or

(b)otherwise—the day that is 1 year after the commencement.

254   St John Ambulance Australia—Queensland

(1)This section applies in relation to an HDPR authority that, immediately before the commencement, authorised a person from St John Ambulance Australia—Queensland to carry out an activity with a substance under the HDPR, section 174B.

(2)The HDPR authority continues in effect as if this Act had not commenced until—

(a)if, within 1 year after the commencement, an appropriately qualified officer of St John Ambulance Australia—Queensland applies for a substance authority equivalent to the HDPR authority—the day the application for the substance authority is decided; or

(b)otherwise—the day that is 1 year after the commencement.

255   Universities

(1)This section applies in relation to an HDPR authority that, immediately before the commencement, authorised the vice-chancellor of a university, or the vice-chancellor’s delegate, to carry out an activity with a substance under the HDPR, section 179A or 265A.

(2)The HDPR authority continues in effect as if this Act had not commenced until—

(a)if, within 1 year after the commencement, an appropriately qualified officer of the university applies for a substance authority equivalent to the HDPR authority—the day the application for the substance authority is decided; or

(b)otherwise—the day that is 1 year after the commencement.

Division 3 Continued applications

256   Existing applications for new interests

(1)This section applies if—

(a)before the commencement, a person applied for an approval, licence or permit (the interest) under the Health Act or the Pest Management Act; and

(b)immediately before the commencement, the person’s application had not been decided.

(2)The person’s application must be decided as if it were—

(a)an application for a substance authority that is equivalent to the interest; and

(b)made under this Act on the commencement.

(3)For subsection (2), if a fee has been paid or waived for the interest, a fee payable under this Act for an application for the substance authority is waived.

257   Amendment or renewal applications for approvals

(1)This section applies if—

(a)before the commencement, a person applied to amend or renew an HDPR approval or pest licence; and

(b)immediately before the commencement, the application had not been decided; and

(c)the HDPR approval or pest licence is continued in effect under this part.

(2)The person’s application must be decided as if it were—

(a)an application to amend or renew a substance authority that is equivalent to the HDPR approval or pest licence; and

(b)made under this Act on the commencement.

(3)For subsection (2), if a fee has been paid or waived for the application, a fee payable under this Act to amend or renew the substance authority is waived.

258   Amendment or repeal applications about suspension or cancellation decisions—HDPR authorities

(1)This section applies if—

(a)before the commencement, a person applied, under the HDPR, section 26A, for the amendment or repeal of a decision (the original decision) to suspend or cancel an HDPR authority; and

(b)immediately before the commencement, the application had not been decided; and

(c)on the commencement, a new authorisation that is an approved person’s authorisation is equivalent to the HDPR authority and applies to the person.

(2)The person’s application must be decided as if it were a request to review administrative action under section 105.

(3)For considering the application under subsection (2), the original decision is taken to be administrative action taken under this Act in relation to the equivalent new authorisation.

259   Amendment or repeal applications about suspension or cancellation decisions—HDPR approvals

(1)This section applies if—

(a)before the commencement, a person applied, under the HDPR, section 26A, for the amendment or repeal of a decision (the original decision) to suspend or cancel an HDPR approval; and

(b)immediately before the commencement, the person’s application had not been decided.

(2)The person’s application must be decided as if it were a request to review administrative action under section 105.

(3)For considering the application under subsection (2)—

(a)the person is taken to be the holder of a substance authority that is equivalent to the HDPR approval; and

(b)the original decision is taken to be administrative action taken under this Act in relation to the substance authority.

Division 4 Continued processes and proceedings

Subdivision 1 Former offences

260   Proceedings for former offences

(1)This section applies in relation to an offence against a provision of the Health Act or Pest Management Act committed by a person before the commencement.

(2)Without limiting the Acts Interpretation Act 1954, section 20, a proceeding for the offence may be continued or started, and the person may be convicted of and punished for the offence, as if this Act had not commenced.

(3)Subsection (2) applies despite the Criminal Code, section 11.

(4)An analysis completed under section 273 may be used in relation to the proceeding to the extent otherwise authorised under the Health Act or Pest Management Act.

261   Applications for recovery of costs

(1)Subsection (2) applies if—

(a)before the commencement, the chief executive applied to a court for an order for the payment of costs under the Health Act, section 153ZL or the Pest Management Act, section 119; and

(b)immediately before the commencement, the application had not been decided.

(2)The application may be decided as if this Act had not commenced.

(3)Subsection (4) applies if a person is convicted of an offence after the commencement because of a proceeding continued or started under section 260.

(4)The chief executive may apply to a court for an order for the payment of costs under the Health Act, section 153ZL or the Pest Management Act, section 119, and the application may be decided, as if this Act had not commenced.

Subdivision 2 Reviews and appeals

262   Review of HDPR decisions

(1)This section applies if, before the commencement, a decision was made by the chief executive under the HDPR and—

(a)immediately before the commencement, the period during which an application for a review of the decision may have been made to QCAT under the HDPR, section 33 had not ended; or

(b)an application was made to QCAT under the HDPR, section 33 for a review of the decision and the application had not been decided by QCAT immediately before the commencement.

(2)The application may be decided, or made and decided, as if this Act had not commenced.

(3)Subsection (4) applies if, as a result of QCAT’s decision on the application, an approval, licence or permit (an interest) would have been granted under the HDPR but for the commencement of this Act.

(4)The chief executive must grant the person a substance authority that is equivalent to the interest and is subject to the conditions that would have applied to the interest had it been granted under the HDPR before the commencement.

263   Review of Pest Management Act decisions

(1)This section applies if, before the commencement, a person was given, or entitled to be given, an information notice for a decision under the Pest Management Act and—

(a)immediately before the commencement, the period during which an application for a review of the decision may have been made under the Pest Management Act, part 4 had not ended; or

(b)an application was made under the Pest Management Act, part 4 for a review of the decision and the application had not been decided immediately before the commencement.

(2)The application may be decided, or made and decided, as if this Act had not commenced.

(3)Subsection (4) applies if, as a result of a decision on the application, a licence would have been granted under the Pest Management Act if this Act had not commenced.

(4)The chief executive must grant the person a pest management licence that is equivalent to the licence under the Pest Management Act and is subject to the conditions that would have applied to the licence, if it had been granted under the Pest Management Act before the commencement.

264   Appeals against forfeiture decisions under Health Act

(1)This section applies if, before the commencement, a thing was forfeited to the State under the Health Act, repealed section 153G(1)(c) and, immediately before the commencement—

(a)the period during which the owner may have started an appeal to a Magistrates Court under the Health Act, part 4A, division 7 had not ended; or

(b)the owner had started an appeal (the first appeal) that had not been decided by the Magistrates Court; or

(c)the period in which the owner may have started an appeal to the District Court from a decision of the Magistrates Court on the first appeal had not ended; or

(d)the owner started an appeal (the second appeal) to the District Court from a decision of the Magistrates Court on the first appeal and the second appeal was not decided.

(2)The first appeal and second appeal may be decided, or started and decided, as if this Act had not commenced.

(3)Also, the owner may start an appeal to the District Court from a decision of the Magistrates Court as if this Act had not commenced.

Subdivision 3 Other continued processes

265   Show cause notices

(1)This section applies if—

(a)before the commencement, a person was given—

(i)a show cause notice under the Pest Management Act, section 44 that was in effect immediately before the commencement; or

(ii)a written notice for a suspension or cancellation under the HDPR, section 24 that was in effect immediately before the commencement; and

(b)on the commencement, the person has a new authorisation that is equivalent to the former authorisation.

(2)The notice is taken to be a show cause notice for administrative action taken under this Act in relation to the new authorisation.

266   Suspension of former authorisations

(1)This section applies if, immediately before the commencement, a suspension (the former suspension) of a person’s former authorisation was in effect.

(2)The former suspension is taken to be administrative action.

(3)If the former authorisation was an HDPR approval or HDPR authority, the suspension notice day for the former suspension is taken to be the review day for the administrative action.

(4)In this section—

suspension notice day, for a suspension, means the day stated in the notice under the HDPR, section 24 for the suspension before which the person was not permitted to apply to the chief executive for an amendment or repeal of the chief executive’s decision under the HDPR, section 26A.

267   Cancellation of HDPR authority

(1)This section applies if, immediately before the commencement, a cancellation (the former cancellation) of a person’s former authorisation that was an HDPR authority was in effect.

(2)The former cancellation is taken to be administrative action.

(3)The cancellation notice day for the former cancellation is taken to be the review day for the administrative action.

(4)In this section—

cancellation notice day, for a cancellation, means the day stated in the notice under the HDPR, section 24 for the cancellation before which the person was not permitted to apply to the chief executive for an amendment or repeal of the chief executive’s decision under the HDPR, section 26A.

268   Surrender of HDPR authority

(1)This section applies if—

(a)immediately before the commencement, a surrender (the former surrender) under the HDPR, section 32 was in effect for a person’s HDPR authority; and

(b)on the commencement, a new authorisation that is an approved person’s authorisation and is equivalent to the HDPR authority applies to the person.

(2)The former surrender is taken to be agreed administrative action.

269   Compliance notices

(1)This section applies to a compliance notice given to a person under the Pest Management Act, section 89 that was in effect immediately before the commencement.

(2)The compliance notice is taken to be a compliance notice under this Act.

270   Warrants

(1)A warrant issued under the Health Act or the Pest Management Act, that was in force immediately before the commencement, continues in force until the earliest of the following—

(a)the warrant is executed;

(b)the warrant is cancelled;

(c)the period during which the warrant can be executed ends.

(2)For this section, the Health Act or Pest Management Act, as the case may be, continues to apply to the warrant as if this Act had not commenced.

271   Requirements made by Health Act inspectors

(1)This section applies to a requirement made by an inspector under the Health Act for a person to do a thing under any of the following provisions of that Act—

•section 151

•section 153E

•section 153N

•section 153Q

•section 153R.

(2)The requirement continues to apply to the person until it has been satisfied or otherwise ends under the terms of the requirement.

(3)The Health Act continues to apply to the requirement as if this Act had not commenced.

272   Requirements made by Pest Management Act inspectors

(1)This section applies to a requirement made by an inspector for a person to do a thing under any of the following provisions of the Pest Management Act—

•section 69

•section 76

•section 83

•section 85

•section 88

•section 89.

(2)The requirement continues to apply to the person until it has been satisfied or otherwise ends under the terms of the requirement.

(3)The Pest Management Act continues to apply to the requirement as if this Act had not commenced.

273   Analysis by State analysts

(1)This section applies if, immediately before the commencement, a State analyst under the Health Act or Pest Management Act—

(a)was undertaking analysis of a thing, whether the analysis was under the Health Act, Pest Management Act or another Act; and

(b)the State analyst had not completed the analysis or a certificate for the analysis.

(2)A State analyst under this Act may continue to analyse the thing and give a certificate of analysis for the thing.

(3)The Health Act continues to apply to the analysis as if this Act had not commenced.

Division 5 Transition of other matters

Subdivision 1 Documents

274   Prescriptions

(1)This section applies if—

(a)before the commencement, a prescription was given under the Health Act for the supply or administration of a substance; and

(b)immediately before the commencement, the substance had not been dispensed, supplied or administered.

(2)The prescription continues in force until the earliest of the following—

(a)the substance is dispensed, supplied or administered;

(b)the prescription is cancelled by a person who had the authority to cancel the prescription under the Health Act;

(c)the period, stated on the prescription or provided for under the Health Act, during which the substance must be supplied or administered ends.

(3)The Health Act continues to apply in relation to the prescription as if this Act had not commenced.

(4)In this section—

prescription means any instrument under the Health Act, other than an HDPR standing order, that, immediately before the commencement, permitted a substance to be dispensed or supplied for, or administered to, a stated person or animal.

275   Purchase orders

(1)This section applies if—

(a)before the commencement, a purchase order was given under the Health Act for the supply of a substance; and

(b)immediately before the commencement, the substance had not been supplied under the purchase order.

(2)If the purchase order was for the supply of a substance other than medicated animal feed, the order continues in force until the earliest of the following—

(a)the substance is supplied under the order;

(b)the order is cancelled by a person who had the authority to cancel the order under the Health Act;

(c)the period, stated on the order or provided for under the Health Act, during which the substance must be supplied ends.

(3)If the purchase order is for the supply of medicated animal feed, the order continues in force until the earliest of—

(a)the day a circumstance mentioned in subsection (2)(a) or (b) applies to the order; or

(b)the day that is 6 months after the commencement.

(4)The Health Act continues to apply to the purchase order as if this Act had not commenced.

276   Standing orders

(1)This section applies to an HDPR standing order in effect immediately before the commencement.

(2)The HDPR standing order continues in force until the day that is 6 months after the commencement.

(3)The Health Act continues to apply to the HDPR standing order as if this Act had not commenced.

277   References to repealed Acts

A reference in a document to the Health Act or Pest Management Act, may, if the context permits, be taken to be a reference to this Act.

Subdivision 2 Offices and functions

278   Inspectors

(1)This section applies to a person who held office as an inspector under the Health Act or Pest Management Act immediately before the commencement.

(2)The person is taken to hold office as an inspector under this Act on the conditions, if any, stated in the person’s instrument of appointment.

(3)This section stops applying to the person on the day that is 6 months after the commencement.

279   State analysts

(1)This section applies to a person who held office as a State analyst under the Health Act or Pest Management Act immediately before the commencement.

(2)The person is taken to hold office as a State analyst under this Act on the conditions, if any, stated in the person’s instrument of appointment.

(3)This section stops applying to the person on the day that is 6 months after the commencement.

Division 6 Extended periods for compliance

280   Substance management plans

(1)This section applies to a responsible person who, on the commencement, would be required under section 93 to make a substance management plan for a regulated place.

(2)The responsible person is not required to comply with the requirements of chapter 4, part 2 until 1 year after the commencement (the transition period).

(3)Subsection (4) applies if the responsible person becomes subject to the requirements in chapter 4, part 2 because a former authorisation is replaced with a substance authority during the transition period.

(4)The responsible person must comply with chapter 4, part 2 when the transition period ends, regardless of when the substance authority is granted.

281   Procedure until monitored medicines database operational

(1)This section applies for the period (the transition period)—

(a)starting on the commencement; and

(b)ending on the day prescribed by regulation to be the day the monitored medicines database is fully operational.

(2)In the transition period—

(a)a person is not liable to be prosecuted for a contravention of section 41 or 226; and

(b)a person to whom the HDPR, section 84(2) to (10) or 84A(3) and (4) applied immediately before the commencement must continue to comply with the section as if this Act had not commenced; and

Note—

The HDPR, sections 84 and 84A provided for a dispenser to send particular information to the chief executive.

(c)a person to whom the HDPR, section 120, 122, 213 or 213A applied immediately before the commencement must continue to comply with the section as if this Act had not commenced.

Note—

The HDPR, sections 120, 122, 213 and 213A provided for approvals for the treatment of drug dependent persons.

(3)This section does not prevent a person complying with this Act to the extent practicable if, during the transition period, the monitored medicines database is able to be used.

Example of complying to the extent practicable—

An information provider under section 226 gives information to the chief executive to the extent the provider is able to access the system required to be used for providing the information to the monitored medicines database.

Division 7 [Repealed]

(Repealed)

Part 3    Transitional provision for Forensic Science Queensland Act 2024

282   Continued appointments

(1)This section applies if—

(a)immediately before the commencement, a person held office as a State analyst appointed under section 189(1); and

(b)on the commencement, the person is a staff member of Forensic Science Queensland.

(2)On the commencement, the person is taken to hold office as a State analyst appointed by the Director of Forensic Science Queensland under section 189(3) on the conditions, if any, stated in the person’s instrument of appointment.

Part 4    Transitional provisions for Health Legislation Amendment Act (No. 2) 2025

283   Definition for part

In this part—

drug checking see section 86A(2).

284   End of authorisation for drug checking under existing substance authorities

(1)This section applies to a substance authority granted before the commencement that, immediately before the commencement, authorised a dealing with a regulated substance for the purpose of drug checking.

(2)On the commencement, the substance authority ends to the extent it authorises the dealing.

(3)However, for the 30-day period, subsection (2) does not affect the authorisation under the substance authority of the following dealings—

(a)possession of the regulated substance;

(b)disposal of the regulated substance.

(4)In this section—

30-day period means the period—

(a)starting on the day of the commencement; and

(b)ending on the day that is 30 days after the day of the commencement.

285   Existing applications to authorise drug checking

Section 86A, as in force on the commencement, applies in relation to an initial application, an amendment application or a renewal application made, but not decided, before the commencement.

286   No compensation or refund payable

No compensation, or refund of any fee paid under the Act, is payable because of—

(a)the ending of an authorisation under section 284; or

(b)the operation of section 285.

Schedule 1 Dictionary

section 8

administer, a medicine, see section 26.

administrative action, in relation to an authority, see section 95.

administrative action register see section 228(a).

administrator, for chapter 7, part 2, see section 219.

affected person, in relation to a decision, for chapter 6, part 1, see section 196.

agreed administrative action see section 103(3).

amendment application see section 78(1).

application, for chapter 3, part 3, division 4, see section 86.

apply, a poison, see section 27.

approved form means a form approved under section 239.

approved label—

(a)of a regulated substance—means a label lawfully made and attached to the substance stating a direction or instruction about how to carry out a regulated activity with the substance; or

(b)of a medicine—includes a dispensing label.

Example—

a label consistent with the Poisons Standard, part 2 or the Agvet Code of Queensland, part 2

Note—

See the Poisons Standard, part 1 for the definition dispensing label.

approved person see section 54(3).

approved person’s authorisation see section 54(5).

Australian Pesticides and Veterinary Medicines Authority means the authority of that name continued in existence under the Agricultural and Veterinary Chemicals (Administration) Act 1992 (Cwlth), section 6.

authorised way see section 31.

authority, for chapter 4, part 3, see section 95.

buy, a regulated substance, see section 22.

compliance notice see section 108(2).

condition, of an approved person’s authorisation, for chapter 4, part 3, see section 95.

confidential information see section 219.

corresponding law means—

(a)the Commonwealth Therapeutic Goods Laws, and the applied therapeutic goods provisions, under the Therapeutic Goods Act 2019; or

(b)a law of another jurisdiction that provides for, or provided for, the same or similar matters as this Act.

court see section 203(2).

criminal history, of a person, means—

(a)a conviction of the person by or before any court for an offence, whether or not recorded, in Queensland or elsewhere, before or after the commencement of this Act; or

(b)an allegation formally made in court that the person has committed an offence, in Queensland or elsewhere, whether before or after the commencement of this Act.

criminal history information means information from a criminal history report or a notice given under section 217(2), other than information in the report or notice that is lawfully available to the public.

criminal history report see section 216(1).

deals, with a regulated substance, see section 18.

departmental standard see section 233(1).

device means an instrument, apparatus, appliance, material or other article, other than a medical device under the Therapeutic Goods Act 1989 (Cwlth), that is used, or intended to be used, with a substance.

Director of Forensic Science Queensland means the director appointed under the Forensic Science Queensland Act 2024, section 7.

dispense, a medicine, see section 25(2).

dispose, of waste from a regulated substance, see section 28.

diversion-risk medicine means a medicine prescribed by regulation to be a diversion-risk medicine.

document certification requirement see section 177(6).

document production requirement see section 177(2).

electronic document ...

emergency order see section 58(1).

emerging risk declaration see section 111.

employ includes engage on a contract for services.

executive officer, of a corporation, means a person who is concerned with, or takes part in, the corporation’s management, whether or not the person is a director or the person’s position is given the name of executive officer.

extended practice authority see section 232(1).

final consideration day, for an application, for chapter 3, part 3, division 4, see section 86.

Forensic Science Queensland means the Office of the Director of Forensic Science Queensland established under the Forensic Science Queensland Act 2024, section 23.

former owner see section 171(1).

fumigant see section 14(1).

fumigation activity see section 19(2).

general approval see section 68(1).

general power see section 158(1).

give a treatment dose, of a medicine, see section 25(3).

harm includes a latent disease or injury.

hazardous poison see section 16.

health ombudsman official means an official under the Health Ombudsman Act 2013.

health practitioner means—

(a)a health practitioner registered under the Health Practitioner Regulation National Law; or

(b)another practitioner who provides a service for maintaining, improving, restoring or managing people’s health or wellbeing; or

(c)an individual training to be a practitioner mentioned in paragraph (a) or (b).

health risk—

(a)in relation to a person—means a risk of harm to the life, health or safety of someone arising from a person carrying out a regulated activity with a regulated substance; or

(b)in relation to a substance—means a risk of harm to the life, health or safety of someone arising from the use, or potential use, of the substance or a device used, or intended to be used, with the substance.

health service employee means a person appointed as a health service employee under the Hospital and Health Boards Act 2011, section 67.

help requirement see section 159(1).

holder—

(a)of an authority, for chapter 4, part 3—see section 95; or

(b)of a substance authority—means the entity granted the substance authority.

identity card, for a provision about inspectors, means an identity card issued under section 135.

information notice, for a decision, means a notice stating the following information—

(a)the decision;

(b)the day the decision takes effect;

(c)the reasons for the decision;

Note—

See the Acts Interpretation Act 1954, section 27B for matters that must be included with the reasons.

(d)that the person to whom the notice is given may ask for a review of the decision under this Act;

(e)how, and the period within which, the review may be started;

(f)if the person may apply for a stay of the operation of the decision under this Act—how the person may apply for the stay.

initial application see section 75.

inspector means a person who holds office as an inspector under chapter 5, part 2.

internal review, of an original decision, for chapter 6, part 1, see section 198(1).

internal review decision, for chapter 6, part 1, see section 196.

manufacture, a regulated substance, see section 21.

manufacturing licence see section 63.

medicine see section 11.

monitored medicine means a medicine prescribed by regulation to be a monitored medicine.

monitored medicines database see section 224(1).

notice means written notice.

occupier, of a place, includes the following—

(a)if there is more than 1 person who apparently occupies the place—any 1 of the persons;

(b)any person at the place who is apparently acting with the authority of a person who apparently occupies the place;

(c)if no-one apparently occupies the place—any person who is an owner of the place.

of, a place, includes at or on the place.

offence warning, for a direction or requirement by an inspector, means a warning that, without a reasonable excuse, it is an offence for the person to whom the direction is given, or of whom the requirement is made, not to comply with it.

original decision, for chapter 6, part 1, see section 196.

owner, of a thing that has been seized under chapter 5, includes a person who would be entitled to possession of the thing had it not been seized.

personal details requirement see section 175(5).

personal information see the Information Privacy Act 2009, section 12.

person in control—

(a)of a vehicle, includes—

(i)the vehicle’s driver or rider; and

(ii)any person who reasonably appears to be, claims to be, or acts as if the person is, the vehicle’s driver or rider or the person in control of the vehicle; or

(b)of another thing, includes any person who reasonably appears to be, claims to be, or acts as if the person is, the person in possession or control of the thing.

pest—

1Pest means an arthropod, bird, mollusc or rodent that injuriously affects, or may injuriously affect, a place, person or animal by—

(a)transmitting disease, a toxin or another pest in the place or to the person or animal; or

(b)causing physical damage to the place or a thing in the place; or

(c)causing distress to, or an adverse physiological or social effect in, the person or animal.

2Pest includes another biological entity prescribed by regulation to be a pest.

3Pest does not include a biological entity prescribed by regulation not to be a pest.

pest control activity see section 19(3).

pesticide see section 14(2).

pest management activity see section 19(1).

pest management business—

(a)means a business in which services are offered that include pest management activities; but

Examples—

pest control services offered by a pest management technician or as part of property management services by a real estate agent

(b)does not include a business in which pest management activities are incidentally carried out when performing services for purposes other than pest management.

Examples—

•a plumber spraying a pesticide on a drain pipe before clearing the pipe

•an electrician spraying a pesticide on a meter box before working on the meter box

pest management licence see section 66.

place includes the following—

(a)premises;

(b)vacant land;

(c)a place in Queensland waters;

(d)a place held under more than 1 title or by more than 1 owner;

(e)the land or water on or in which a building or other structure, or a group of buildings or other structures, is situated.

poison see section 12.

Poisons Standard means the current Poisons Standard within the meaning of the Therapeutic Goods Act 1989 (Cwlth), section 52A(1).

police commissioner ...

possess, a regulated substance, see section 23.

premises includes—

(a)a building or other structure; and

(b)a part of a building or other structure; and

(c)a caravan or vehicle; and

(d)a cave or tent; and

(e)premises held under more than 1 title or by more than 1 owner.

prepare, a regulated substance, includes measure, mix or weigh the substance.

prescribe, in relation to a medicine, means direct a person, orally or in writing, to administer, dispense or give a treatment dose of the medicine for the treatment of a person or animal.

prescribing approval see section 67.

prescription, in relation to a medicine, means a direction, orally or in writing, to administer, dispense or give a treatment dose of the medicine for the treatment of a person or animal.

prohibited substance see section 13.

property decision see section 203(1).

public place means—

(a)a place, or part of the place—

(i)that the public is entitled to use, is open to members of the public or is used by the public, whether or not on payment of money; or

Examples of a place that may be a public place under subparagraph (i)—

a beach, a park, a road

(ii)the occupier of which allows, whether or not on payment of money, members of the public to enter; or

Examples of a place that may be a public place under subparagraph (ii)—

a saleyard, a showground

(b)that is a public place under another Act.

purchase order means a document requesting the supply of stock of a regulated substance from a supplier of the substance.

QCAT information notice, for a decision, means a notice complying with the QCAT Act, section 157(2).

reasonably believes means believes on grounds that are reasonable in the circumstances.

reasonably suspects means suspects on grounds that are reasonable in the circumstances.

recall order see section 119(2).

regulated activity see section 20.

regulated place, for chapter 4, part 2, see section 92.

regulated substance see section 17.

relevant person—

1Relevant person, for a substance authority, means any of the following persons—

(a)the person applying for, or holding, the authority;

(b)a person acting in partnership with the applicant for, or the holder of, the authority;

(c)a person who is, or is proposed to be, responsible for overseeing or supervising the regulated activity under the authority;

(d)if the applicant for, or the holder of, the authority is a corporation—an executive officer of the corporation.

2Relevant person, in relation to an approved person’s authorisation, means the approved person.

renewal application see section 82(1).

responsible person—

(a)for a regulated place, for chapter 4, part 2, see section 92; or

(b)for a recall order, see section 119(2)(a).

retail licence means an S2 retail licence or an S7 retail licence.

review day, for administrative action, see section 95.

S2 medicine see section 11(1)(a).

S2 retail licence see section 65(1).

S3 medicine see section 11(1)(b).

S4 medicine see section 11(1)(c).

S5 poison see section 12(1)(a).

S6 poison see section 12(1)(b).

S7 poison see section 12(1)(c).

S7 retail licence see section 65(2).

S7 substance see section 15.

S8 medicine see section 11(1)(d).

S9 prohibited substance see section 13(1)(a).

S10 prohibited substance see section 13(1)(b).

sell, a regulated substance, see section 25(1).

show cause notice, for chapter 4, part 3, see section 97(2).

show cause period, for chapter 4, part 3, see section 97(2)(d).

standard condition, for a substance authority, see section 70(1)(a).

standing order, for a medicine, means a document authorising the medicine to be administered or given as a treatment dose at a stated place or in stated circumstances.

State analyst means a person who holds office under chapter 5, part 6 as a State analyst.

stock means—

(a)a regulated substance that is intended for supplying a place or a person who is authorised to carry out a regulated activity with the substance; or

(b)a regulated substance that is not sold or dispensed to a particular person.

substance see section 10.

substance authority see section 61.

substance authority register see section 228(b).

substance management plan, for a regulated place, see section 92.

supply, a regulated substance, see section 24.

vehicle—

(a)means a vehicle under the Transport Operations (Road Use Management) Act 1995; and

(b)includes a vessel under that Act.

veterinary surgeon see the Veterinary Surgeons Act 1936.

waste, from a regulated substance, means the regulated substance in a form that—

(a)is leftover, or is an unwanted by-product, from a manufacturing process; or

(b)is surplus or unwanted; or

(c)is expired or otherwise unusable.

wholesale licence see section 64.

worker, for an entity, means a person who—

(a)is employed by the entity; or

(b)is a student of, or volunteer for, the entity.