Medicines, Poisons and Therapeutic Goods Regulation 2008

the kava is prepared, possessed and consumed in connection with an event declared by the Minister; and

any conditions stated in the declaration are complied with.

The Minister may declare an event only if satisfied it is a public event.

Example

National Multicultural Festival

A declaration may include conditions about any of the following:

the dates and times when the kava may be prepared or consumed;

the way in which the kava may be prepared or consumed;

the places where the kava may be prepared or consumed;

the minimum age of people who may consume the kava;

signage for the event;

anything else the Minister considers appropriate.

A declaration is a notifiable instrument.

Schedule 1 Medicines—health-related occupations authorisations

(see s 30, s 50, s 60, s 110, s 350, s 370 and s 380)

Part 1.1 Ambulance services, officers and paramedics

column 1

item

column 2

person authorised

column 3

authorisation

1

ambulance officer or paramedic employed by Commonwealth, Territory or State

within scope of employment, do any of the following:

obtain medicines;

possess medicines;

administer medicines

Note Paramedic does not include a person holding student, limited or provisional registration to practise in the profession (see dict).

2

person in charge of ambulance service operated by Commonwealth, Territory or State

within scope of employment, do any of the following:

issue purchase orders for medicines;

obtain medicines mentioned in par (a);

possess medicines mentioned in par (a);

supply medicines to ambulance officers and paramedics in ambulance service

Part 1.2 Dentists, dental hygienists, dental therapists and oral health therapists

column 1

item

column 2

person authorised

column 3

authorisation

1

dentist

to the extent necessary to practise dentistry and, if employed, within the scope of employment, do any of the following:

issue purchase orders and requisitions for medicines;

obtain medicines;

possess medicines

administer medicines;

prescribe medicines;

supply medicines to patients during consultations if labelled in accordance with s 161;

supply medicines for administration to patients at dental surgery to people authorised to administer them

Note Dentist does not include a trainee dentist (see dict).

2

trainee dentist

to the extent necessary to practise dentistry or undertake training, and under supervision of dentist, do any of the following:

obtain medicines from health practitioner authorised to possess them;

possess medicines;

administer medicines in accordance with prescription (whether or not issued by themself or dentist);

prescribe medicines for administration at institution or dental surgery

3

dental hygienist

within the scope of employment, to the extent necessary to practise as dental hygienist, and in a structured professional relationship with a dentist, do any of the following:

obtain medicines from dentist authorised to possess them;

possess medicines mentioned in par (a);

administer medicines mentioned in par (a) in accordance with dentist’s prescription

4

dental therapist

within the scope of employment, to the extent necessary to practise as dental therapist, and in a structured professional relationship with a dentist, do any of the following:

issue purchase orders and requisitions for medicines for topical dental use and for local anaesthetics;

obtain medicines mentioned in par (a);

possess medicines mentioned in par (a);

administer medicines mentioned in par (a)

5

oral health therapist

within the scope of employment, to the extent necessary to practise as an oral health therapist, and in a structured professional relationship with a dentist, do any of the following:

issue purchase orders and requisitions for medicines for topical dental use and for local anaesthetics;

obtain medicines mentioned in par (a);

possess medicines mentioned in par (a);

administer medicines mentioned in par (a)

Part 1.3 Doctors

column 1

item

column 2

person authorised

column 3

authorisation

1

doctor

to the extent necessary to practise medicine and, if employed, within the scope of employment, do any of the following:

issue purchase orders and requisitions for medicines;

obtain medicines;

possess medicines;

administer medicines;

prescribe medicines;

supply medicines to patients during consultations;

supply medicines for administration to patients to people authorised to administer them;

supply medicines dispensed for patient to another health practitioner on patient’s transfer within institution;

supply medicines dispensed for patient to patient on patient’s discharge from institution;

supply medicines to patients during consultations if labelled in accordance with s 161

Note For authorisation to issue standing orders for administration of medicines at institutions, see s 75.

Note Doctor does not include an intern doctor (see dict).

2

intern doctor

to the extent necessary to practise medicine or undertake training or supervised practice, and under supervision of doctor, do any of the following:

obtain medicines from health practitioner authorised to possess them;

possess medicines;

administer medicines in accordance with prescription (whether or not issued by themself or another prescriber);

prescribe medicines for administration at institution or surgery;

prescribe medicines for patient on patient’s discharge from institution;

supply medicines dispensed for patient to another health practitioner on patient’s transfer within institution;

supply medicines dispensed for patient to patient on patient’s discharge from institution

Part 1.4 Health practitioners at institutions

column 1

item

column 2

person authorised

column 3

authorisation

1

health practitioner employed at institution

within the scope of employment, do any of the following for the delivery of medicines within the institution to a health practitioner or health professional authorised to obtain the medicines:

obtain the medicines;

possess the medicines;

supply the medicines

Part 1.4A Medical radiation practitioners

column 1

item

column 2

person authorised

column 3

authorisation

1

medical radiation practitioner

to the extent necessary to practise as a medical radiation practitioner in accordance with the MRP registration standard and, if employed, within the scope of employment, do any of the following:

issue purchase orders and requisitions for medicines;

obtain medicines;

possess medicines;

administer medicines

Note Medical radiation practitioner does not include a person holding student, limited or provisional registration to practise in the profession (see dict).

Part 1.5 Midwives

column 1

item

column 2

person authorised

column 3

authorisation

1

midwife

to the extent necessary to practise midwifery and, if employed, within the scope of employment, do any of the following:

issue requisitions for medicines;

obtain medicines on requisition;

possess medicines;

administer medicines in accordance with prescription or standing order;

supply medicines in accordance with a standing order issued by chief health officer or a requisition;

supply medicines dispensed for patient to another health practitioner on patient’s transfer within institution;

supply medicines dispensed for patient to patient on patient’s discharge from institution

Part 1.6 Nurses

column 1

item

column 2

person authorised

column 3

authorisation

1

nurse

to the extent necessary to practise nursing and, if employed, within the scope of employment, do any of the following:

issue requisitions for medicines;

obtain medicines on requisition;

possess medicines;

administer medicines in accordance with prescription or standing order;

supply medicines in accordance with a standing order issued by chief health officer or a requisition;

supply medicines dispensed for patient to another health practitioner on patient’s transfer within institution;

supply medicines dispensed for patient to patient on patient’s discharge from institution

Note Nurse does not include enrolled nurse (see Legislation Act, dict, pt 1).

2

trainee nurse

if successfully completed pharmacology units of nursing studies, to the extent necessary to practise nursing as trainee nurse or undertake training, and under supervision of nurse or midwife, do any of the following:

obtain medicines from health practitioner authorised to possess them;

possess medicines;

administer medicines to patients in accordance with prescription

3

enrolled nurse

to the extent necessary to practise nursing as enrolled nurse and, if employed, within the scope of employment, do any of the following:

obtain medicines from health practitioner authorised to possess them;

possess medicines;

administer medicines in accordance with prescription

Part 1.7 Opioid dependency treatment centres operated by Territory

column 1

item

column 2

person authorised

column 3

authorisation

1

person in charge of opioid dependency treatment centre operated by Territory

to the extent necessary to treat patients of centre and within the scope of employment, do any of the following:

issue purchase orders and requisitions for buprenorphine and methadone;

obtain buprenorphine and methadone on purchase orders and requisitions;

supply buprenorphine and methadone to health practitioners at centre for patients of centre

2

doctor or nurse at opioid dependency treatment centre operated by Territory

to the extent necessary to treat patients of centre and within the scope of employment, supply buprenorphine and methadone to patients of centre for self‑administration outside centre if—

supply is in accordance with prescription; and

medicine is labelled as if dispensed medicine; and

labelled medicine checked by another health practitioner before supply

Note 1 For authorisation of doctor to issue standing orders for administration of medicines at centre, see s 75.

Note 2 For labelling of dispensed medicines, see s 123.

Part 1.8 Optometrists

column 1

item

column 2

person authorised

column 3

authorisation

1

optometrist

to the extent necessary to practise optometry and, if employed, within the scope of employment, to deal as follows with medicines mentioned in the medicines and poisons standard, schs 2, 3 and 4:

issue purchase orders for the medicines;

issue requisitions for the medicines;

obtain the medicines;

possess the medicines;

administer the medicines

Part 1.9 Pharmacists and employees

column 1

item

column 2

person authorised

column 3

authorisation

1

pharmacist

to the extent necessary to practise pharmacy and, if employed, within the scope of employment, do any of the following:

issue purchase orders and requisitions for medicines;

obtain medicines;

possess medicines;

dispense medicines;

administer medicines;

manufacture medicines to dispense or supply them on requisition;

supply pharmacy medicines;

if pharmacist at institution—supply pharmacist only medicines without prescription;

if pharmacist at community pharmacy—supply pharmacist only medicines without prescription but in accordance with the Act, s 7;

supply medicines on purchase order, requisition or standing order

Note 1 Manufacture—see the Act, dictionary.

Note 2 Pharmacist does not include an intern pharmacist (see dict).

2

intern pharmacist

to the extent necessary to practise pharmacy or undertake training or supervised practice, do any of the following:

under direct supervision of pharmacist do 1 or more of the following:

administer medicines;

if intern pharmacist at institution—supply pharmacist only medicines without prescription;

if intern pharmacist at community pharmacy—supply pharmacist only medicines without prescription but in accordance with the Act, s 7;

to obtain, possess and supply medicines for the purpose of assisting pharmacist to dispense them;

under supervision of pharmacist, do 1 or more of the following:

obtain medicines;

possess medicines;

supply pharmacy medicines;

supply medicines on requisition

3

employee assisting pharmacist employed at hospital

within the scope of employment and under direct supervision of pharmacist, do any of the following:

obtain medicines;

possess medicines;

to obtain, possess and supply medicines for the purpose of assisting pharmacist to dispense them;

supply medicines on requisition

4

employee at a community pharmacy

within the scope of employment and—

under supervision of pharmacist, supply—

pharmacy medicines; or

pharmacist only medicines supplied in person to customer by pharmacist if supply is for purpose of sale of medicine; or

medicines dispensed at the pharmacy if the delivery or sale is to the person for whom the medicine is prescribed or the person’s agent; and

under supervision of pharmacist, obtain and possess medicines for purpose of par (a); and

under direct supervision of pharmacist, do any of the following for purpose of assisting pharmacist to dispense medicines:

obtain the medicines;

possess the medicines

Part 1.10 Podiatrists

column 1

item

column 2

person authorised

column 3

authorisation

1

podiatrist

to the extent necessary to practise podiatry and, if employed, within the scope of employment, do any of the following:

issue purchase orders and requisitions for adrenaline and local anaesthetics;

obtain adrenaline and local anaesthetics;

possess adrenaline and local anaesthetics;

administer adrenaline and local anaesthetics

Part 1.11 Residential care facilities

column 1

item

column 2

person authorised

column 3

authorisation

1

director of nursing for residential aged care facility without pharmacy

medical superintendent for residential aged care facility without pharmacy

within the scope of employment, do any of the following:

issue purchase orders for following medicines for emergency administration to residents at facility under direction of prescriber:

pharmacy medicines, pharmacist only medicines and prescription only medicines;

not more than 30 ampoules, each of 1mL or less, of morphine sulphate, at a concentration of 30mg or less of morphine sulphate per mL;

not more than 5 ampoules, each of 1mL or less, of hydromorphone, at a concentration of 2mg or less of hydromorphone per mL;

obtain the medicines mentioned in par (a);

possess the medicines mentioned in par (a);

supply medicines mentioned in par (a) to health practitioner at facility for administration to residents

Note 1 No authorisation is required for certain dealings with residents’ own medicines, see s 371.

Note 2 For the administration of medicines by staff, see s 361.

Note 3 For authorisation of doctor to issue standing orders for administration of medicines at facility, see s 75.

2

director of nursing for residential disability care facility without pharmacy

medical superintendent for residential disability care facility without pharmacy

within the scope of employment, do any of the following:

issue purchase orders for medicines (other than controlled medicines) for emergency administration to residents at facility under direction of prescriber;

obtain the medicines;

possess the medicines;

supply the medicines to health practitioner at facility for administration to residents

Note See the notes to item 1.

Part 1.12 Sales representatives for medicines manufacturers and wholesalers

column 1

item

column 2

person authorised

column 3

authorisation

1

representative of person authorised (however described) under corresponding law to manufacture medicines

representative of medicines wholesalers licence-holder

representative of person authorised to supply medicines under the Act, s 20 (4) (which is about wholesalers who do not have a place of business in the ACT)

for purpose of supplying medicines (other than controlled medicines) under medicines Australia code of conduct, and within the scope of employment, do any of the following:

obtain manufacturer’s packs of medicines (other than controlled medicines) from manufacturer or wholesaler;

possess medicines obtained under par (a);

supply manufacturer’s packs of medicines in accordance with medicines Australia code of conduct

Part 1.13 Veterinary practitioners and employees

column 1

item

column 2

person authorised

column 3

authorisation

1

veterinary practitioner

to the extent necessary to practise veterinary medicine and, if employed, within the scope of employment, do any of the following:

issue purchase orders for medicines;

obtain medicines;

possess medicines;

administer medicines;

prescribe medicines;

supply—

pharmacy medicines if labelled with words to the effect of ‘for animal treatment only’; or

pharmacist only medicines supplied in person by a veterinary practitioner if labelled with words to the effect of ‘for animal treatment only’; or

medicines to custodians of animals during consultations if labelled in accordance with s 161

Note Custodian, of an animal—see the dictionary.

2

veterinary practitioner’s employee

public employee assisting veterinary practitioner who is public employee

within the scope of employment and under supervision of veterinary practitioner, do any of the following:

obtain medicines from veterinary practitioner authorised to possess them;

possess medicines mentioned in par (a);

administer medicines mentioned in par (a) in accordance with veterinary practitioner’s prescription;

supply pharmacy medicines if labelled with words to the effect of ‘for animal treatment only’;

supply pharmacist only medicines supplied in person by a veterinary practitioner if supply is for purpose of sale or delivery of medicine;

supply medicines supplied in person by a veterinary practitioner at the place of employment if labelled in accordance with s 161

Schedule 3 ACT listed appendix D medicines—standing approvals

(see s 31, s 41, s 160, s 591, s 592 and s 593)

Part 3.1 Approval conditions

3.1 Definitions—sch 3

In this schedule:

approved indication means an indication that is accepted by the Secretary of the Australian Government Department of Health in relation to the medicine in the Australian Register of Therapeutic Goods.

Note Approved indications are shown in the public summary of the Australian Register of Therapeutic Goods on the Therapeutic Goods Administration website at www.tga.gov.au.

condition 1, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, means the prescriber must ensure that the possibility of pregnancy by the woman has been excluded prior to commencement of treatment.

condition 2, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, means the prescriber must advise the woman to avoid becoming pregnant during, or for a period of 1 month after the completion of, treatment.

condition 3, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, means the prescriber must advise the woman to avoid becoming pregnant during, or for a period of 3 months after the completion of, treatment.

condition 4, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, means the prescriber must advise the woman to avoid becoming pregnant during, or for a period of 24 months after the completion of, treatment.

Part 3.2 Standing approvals for ACT listed appendix D medicines

column 1 item

column 2 prescriber

column 3 medicine

column 4

conditions (if any)

1

specialist practising in specialist area of dermatology

acitretin for human use

alefacept for human use

bexarotene for human use

etretinate for human use

isotretinoin for human oral use

thalidomide for human use

conditions 1 and 4

conditions 1 and 2

conditions 1 and 4

conditions 1 and 2

conditions 1 and 2

2

specialist practising in specialist area of endocrinology, gynaecology or obstetrics

clomiphene for human use

corifollitropin alfa for human use

cyclofenil for human use

dinoprost for human use

dinoprostone for human use

follitropin alpha (recombinant human follicle‑stimulating hormone) for human use

follitropin beta (recombinant human follicle‑stimulating hormone) for human use

follitropin delta (recombinant human follicle‑stimulating hormone) for human use

luteinising hormone for human use

urofollitropin (human follicle‑stimulating hormone) for human use

3

specialist practising in specialist area of mental health

doctor employed by Territory and working under supervision of chief psychiatrist under Mental Health Act 2015

clozapine for human use

4

specialist physician

ambrisentan for human use

acitretin for human use

etretinate for human use

bexarotene for human use

bosentan for human use

enzalutamide for human use

isotretinoin for human oral use

lenalidomide for human use

macitentan for human use

pomalidomide

riociguat for human use

sitaxentan for human use

teriparatide for human use

thalidomide for human use

tretinoin for human oral use

conditions 1 and 3

conditions 1 and 4

conditions 1 and 4

conditions 1 and 2

conditions 1 and 3

conditions 1 and 3

conditions 1 and 2

conditions 1 and 2

conditions 1 and 3

conditions 1 and 2

conditions 1 and 2

conditions 1 and 3

conditions 1 and 2

conditions 1 and 2

5

specialist practising in specialist area of dentistry, dermatology, intensive care medicine, paediatrics and child health, physician, emergency medicine

hydroxychloroquine

for initial treatment

6

prescriber

hydroxychloroquine

for treatment initiated before commencement of the Poisons Standard Amendment (Hydroxychloroquine and Salbutamol) Instrument 2020 (Cwlth) (F2020L00291);or

for continuation of treatment initiated by a specialist under item 5

7

specialist practising in specialist area of dermatology, gastroenterology and hepatology, infectious diseases, paediatric gastroenterology and hepatology, paediatric infectious diseases

ivermectin

for initial treatment for an indication that is not an approved indication

8

prescriber

ivermectin

for initial and continued treatment for an indication that is an approved indication; or

for continuation of treatment initiated by a specialist under item 7

9

prescriber

nicotine for human use

Note 1 Specialist includes a doctor training in a specialist area—see the dictionary.

Note 2 The Poisons Standard Amendment (Hydroxychloroquine and Salbutamol) Instrument 2020 (Cwlth) (F2020L00291) commenced on 24 March 2020.

Schedule 4 Dangerous poisons—manufacturing etc authorisations

(see s 690)

column 1 item

column 2 people

column 3 dangerous poison

column 4 prescribed purpose

1

manufacturers of glass

arsenic

manufacturing glass

metallurgists

manufacturing alloys

2

manufacturers of dyes or pharmaceuticals

benzene

manufacturing dyes or pharmaceuticals

manufacturers of lacquers, linoleum, protective cloths or varnishes

manufacturing lacquers, linoleum, protective cloths or varnishes

3

manufacturers of chemicals or pharmaceuticals

carbon tetrachloride

manufacturing chemicals or pharmaceuticals

manufacturers of lacquers, paints or varnishes

manufacturing lacquers, paints or varnishes

4

managers of swimming pools, other than domestic swimming pools

chlorine

purifying water in pools

manufacturers of chemicals, plastics or synthetic rubber

manufacturing chemicals, plastics or synthetic rubber

metallurgists

cleaning metals

people working at sewage treatment centres

treating sewage at treatment centres

people working at water treatment centres

purifying water at treatment centres

5

electroplaters

cyanides

electroplating

jewellers

manufacturing gold jewellery

miners

extracting or processing gold

6

manufacturers of lacquers, paints or varnishes

epichlorohydrin

manufacturing lacquers, paints or varnishes

7

manufacturers of chemicals or detergents

ethylene oxide

manufacturing chemicals or detergents

sterilising technologists

sterilising surgical instruments

8

glass workers

hydrofluoric acid

etching glass

masons

cleaning building materials

metal workers

cleaning or etching metals

miners

extracting or processing gold

potters

cleaning ceramics

9

manufacturers of lamps, mirrors or scientific instruments

mercury

manufacturing of lamps, mirrors or scientific instruments

manufacturers of mercury salts or organic compounds

manufacturing mercury salts or organic compounds

miners

extracting metals from ores

10

manufacturers of plastics

4, 4’-methylenebis [2‑chloroaniline] (MOCA)

manufacturing plastics

11

manufacturers of detergents, lubricants or organic compounds

propylene oxide

manufacturing detergents, lubricants or organic compounds

12

manufacturers of organic compounds, paints, rust removers or varnishes

tetrachloroethane

manufacturing organic compounds, paints, rust removers or varnishes

13

manufacturers of dyes

ortho-tolidine

manufacturing dyes

14

manufacturers of disinfectants, household cleaners or industrial deodorants

trichloroisocyanuric acid

manufacturing disinfectants, household cleaners or industrial deodorants

Schedule 5 Requirements for storage receptacles

(see s 531 and s 533)

Part 5.1 Medicines cabinets

5.1 Medicines cabinets—general requirements

A medicines cabinet must be constructed to prevent ready access to the cabinet’s contents by cutting, sawing or unbolting.

5.2 Medicines cabinets—body requirements

The body of a medicines cabinet must be constructed of a single layer of black mild steel plate at least 10mm thick and with continuous welding of all joints.

The body must have, for installation—

4 suitably sized holes in the cabinet’s back plate; or

2 suitably sized holes in the back plate and 2 suitably sized holes in the cabinet’s base.

5.3 Medicines cabinets—door requirements

The door of a medicines cabinet must be constructed of black mild steel plate at least 10mm thick.

When the medicines cabinet door is closed, the door must—

fit flush with the cabinet; and

have a clearance around the door of not more than 1.5mm.

The door must be fitted with a fixed locking bar, welded to the inside face of the door near the hinge edge, that engages in a rebate in the cabinet when closed.

The hinges on the door must be—

constructed of heavy duty steel; and

continuous welded to the door and body of the cabinet.

5.4 Medicines cabinets—lock requirements

A medicines cabinet lock must be—

a 6-lever pick-proof lock; or

a lock mechanism of a level of security equal to, or greater than, a 6-lever pick-proof lock.

The lock must be securely attached to the inside face of the door.

5.5 Medicines cabinets—mounting requirements

A medicines cabinet must be—

embedded in a floor of reinforced concrete of at least 10mpa compressive strength; or

securely fixed to a wall or floor (or both) in accordance with this section.

If the wall and floor are brick or concrete, the medicines cabinet must be fixed to the wall or floor (or both) by at least 4 expanding bolts.

If the wall is timber, but the floor is brick or concrete, the medicines cabinet must be fixed—

to the floor by at least 4 expanding bolts; and

to the wall by at least 2 coach screws into the studs as close to the top of the wall face as is possible.

If the wall and floor are timber, the medicines cabinet must be fixed to the timber frame of the wall or floor in a way that will ensure that the cabinet cannot be removed from the floor or wall within 30 minutes.

The bolts and coach screws must be at least 10mm in diameter.

Part 5.2 Safes, strong rooms and vaults

5.6 Requirements for safes

A safe must be constructed to prevent ready access to the safe’s contents by cutting, sawing or unbolting.

When locked, a safe must reasonably be expected to resist attempts to gain entry by tools, torch or explosives for at least 30 minutes.

A safe—

may be freestanding if it weighs more than 350kg; or

must be securely attached to, or embedded in, a concrete floor or a concrete or brick wall in a way that will ensure that the cabinet cannot be removed from the floor or wall within 30 minutes.

5.7 Requirements for strong rooms

The walls, floor and ceiling of a strong room must be brick or concrete.

The strong room must be fitted with a door.

When locked, the strong room must reasonably be expected to resist attempts to gain entry by tools, torch or explosives for at least 1 hour.

5.8 Requirements for vaults

The walls, floor and ceiling of a vault must be reinforced concrete.

The vault must be fitted with a door.

When locked, the vault must reasonably be expected to resist attempts to gain entry by tools, torch or explosives for at least 1 hour.

Dictionary

(see s 3)

Note 1 The Legislation Act contains definitions and other provisions relevant to this regulation.

Note 2 For example, the Legislation Act, dict, pt 1, defines the following terms:

 ACAT

 chief health officer

 child

 contravene

 corporation

 correctional centre

 dentist

 doctor

 enrolled nurse

 health practitioner

 home address

 midwife

 Minister (see s 162)

 nurse

 nurse practitioner

 optometrist

 pharmacist

 public employee

 reviewable decision notice

 under.

Note 3 Terms used in this regulation have the same meaning that they have in the Medicines, Poisons and Therapeutic Goods Act 2008 (see Legislation Act, s 148). For example, the following terms are defined in the Medicines, Poisons and Therapeutic Goods Act 2008, dictionary:

 authorised, to deal with a regulated substance (see s 20)

 controlled medicine (see s 11)

 dangerous poison (see s 12)

 day hospital

 deals, with a regulated substance (see s 19)

 deals, with a regulated therapeutic good (see s 21)

 dispense

 hospital

 institution

 medicine (see s 11)

 medicines advisory committee

 medicines and poisons standard (see s 15)

 monitored medicine (see s 97A)

 opioid dependency treatment centre

 pharmacist only medicine (see s 11)

 possess, for a regulated substance (see s 24)

 prescribe

 prescription only medicine (see s 11)

 prohibited substance (see s 13)

 purchase order

 register, for a regulated substance

 regulated substance (see s 10)

 requisition

 residential aged care facility

 signs

 supply (see s 24)

 supply authority (see s 23)

 ward

 written.

ACT listed appendix D medicine—see section 589.

appendix D medicine—see section 588.

appendix D medicines approval—see section 590.

approved analyst means—

an analyst appointed under the Public Health Act 1997, section 15 who is authorised under that Act to exercise a function under the Act; or

an analyst appointed or authorised under another territory law or a law of the Commonwealth, a State or another Territory.

approved pharmacist––see the National Health Act 1953 (Cwlth), section 84 (1), as in force from time to time.

Note The National Health Act 1953 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 and 8 means the Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 prepared by the National Coordinating Committee on Therapeutic Goods, as in force from time to time.

Note The Australian Code of Good Wholesaling Practice for Medicines in Schedules 2, 3, 4 and 8 is accessible at www.tga.gov.au.

authorised midwife—see the National Health Act 1953 (Cwlth), section 84 (1), definition of authorised midwife.

bioequivalent—a form of a substance is the bioequivalent of another form of the substance if the forms are physiologically equivalent in their clinical effect.

chief pharmacist, for an institution with a pharmacy, means the pharmacist having the supervision of all other pharmacists employed at the institution.

CHO means chief health officer.

community pharmacy means a pharmacy at a place other than an institution.

complying purchase order means—

for a medicine—a purchase order that complies with section 62; or

for a dangerous poison—a purchase order that complies with section 721; or

for a schedule 10 substance or prohibited substance—see section 772.

condition 1, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, for schedule 3 (ACT listed appendix D medicines—standing approvals)—see schedule 3, section 3.1.

condition 2, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, for schedule 3 (ACT listed appendix D medicines—standing approvals)—see schedule 3, section 3.1.

condition 3, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, for schedule 3 (ACT listed appendix D medicines—standing approvals)—see schedule 3, section 3.1.

condition 4, for a prescriber prescribing or supplying an ACT listed appendix D medicine to a woman of child-bearing age, for schedule 3 (ACT listed appendix D medicines—standing approvals)—see schedule 3, section 3.1.

continued dispensing determination means a determination made by the Minister under the National Health Act 1953 (Cwlth), section 89A (When pharmaceutical benefits may be supplied by approved pharmacists without prescription), as in force from time to time, about the supply of a pharmaceutical benefit to a person by an approved pharmacist without a prescription.

Note See the National Health (Continued Dispensing) Determination 2012 (Cwlth). The determination does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

controlled medicines approval—see section 550.

controlled medicines prescribing standards—see section 575.

controlled medicines register means a register for controlled medicines.

controlled medicines research and education program licence—see section 600.

custodian, of an animal, means—

an adult who has lawful custody of the animal; or

if the animal is owned by a child or a person with a guardian—a parent or guardian of the child or person.

CYP authorised person—see the Children and Young People Act 2008, dictionary, definition of authorised person.

CYP detention place means a detention place under the Children and Young People Act 2008.

dangerous poisons manufacturers licence—see section 700.

dangerous poisons register means a register for dangerous poisons.

dangerous poisons research and education program licence—see section 700.

dangerous poisons suppliers licence—see section 700.

dentist does not include a trainee dentist.

Note See the definition of trainee.

designated prescriber, for part 13.1 (Controlled medicines approvals)—see section 551.

designated prescription only medicine, for part 4.3 (Authorisation to supply without prescription in emergencies)—see section 250.

detainee—see the Corrections Management Act 2007, section 6.

disability care means care that is provided to a person with a disability in a residential facility in which the person is also provided with accommodation that includes—

appropriate staff to meet the nursing and personal care needs of the person; and

meals and cleaning services; and

furnishings, furniture and equipment for the provision of the care and accommodation.

doctor does not include an intern doctor.

Note See the definition of intern.

drug-dependent person, in relation to a controlled medicine or prohibited substance, means a person with a condition—

who, as a result of the administration of the medicine or substance, demonstrates, in relation to the person’s use of the medicine or substance—

impaired control; or

drug-seeking behaviour that suggests impaired control; and

who, as a result of the cessation of the administration of the medicine or substance, is likely to experience symptoms of mental or physical distress or disorder.

endorsed health practitioner—see section 490 (1).

endorsement, for division 13.1.4 (Endorsements to treat drug‑dependency)—see section 580.

environmental authorisation means—

an environmental authorisation under the Environment Protection Act 1997; or

an authorisation (however described) under a Commonwealth or State law that corresponds to the environmental authorisation mentioned in paragraph (a).

first-aid kit includes a portable bag or container of medicines and other medical supplies kept by a person for health care or emergency treatment.

first-aid kit licence—see section 600.

in-patient, at an institution, includes—

a patient being treated at an emergency department of the institution; and

for a correctional centre—a detainee; and

for a CYP detention place—a young detainee.

Note A correctional centre and a CYP detention place is an institution (see s 652).

intern, in relation to a doctor or pharmacist, means—

for a doctor—a person holding limited or provisional registration to practise in the medical profession under the Health Practitioner Regulation National Law (ACT), for the purpose of undertaking a period of supervised practice that the person has started; and

for a pharmacist—a person holding limited or provisional registration to practise in the pharmacy profession under the Health Practitioner Regulation National Law (ACT), for the purpose of undertaking a period of supervised practice or course of training, or both, to allow the person to be registered to practise without supervision.

issuer, for part 3.2 (Requisitioning medicines)—see section 49.

key, for chapter 11 (Storage of medicines)—see section 511.

manufacturer’s pack means a primary pack for a medicine that is supplied by a manufacturer.

medical radiation practitioner—

means a person holding registration to practise in the medical radiation practice profession under the Health Practitioner Regulation National Law (ACT); but

does not include a person holding student, limited or provisional registration for the purpose of undertaking a period of supervised practice or course of training, or both, to allow the person to be registered to practise without supervision.

medical records includes—

for a person at an institution—the person’s clinical records and a medication chart for the person at the institution; and

for a person who is not at an institution and is being treated by a prescriber—any record the prescriber keeps about the person.

medicines Australia code of conduct means the Medicines Australia Code of Conduct, authorised by the Australian Competition and Consumer Commission, as in force from time to time.

Note The Medicines Australia Code of Conduct is accessible at www.medicinesaustralia.com.au.

medicines wholesalers licence—see section 600.

MRP registration standard means the Professional Capabilities for Medical Radiation Practitioners developed by the Medical Radiation Practice Board of Australia and approved by the Ministerial Council under the Health Practitioner Regulation National Law (ACT), as in force from time to time.

Note The Professional Capabilities for Medical Radiation Practitioners (also referred to as the Professional Capabilities for Medical Radiation Practice) is accessible at https://www.medicalradiationpracticeboard.gov.au.

national residential medication chart prescription means a medication chart prescription within the meaning of the National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth), section 41 (4), as in force from time to time.

Note The National Health (Pharmaceutical Benefits) Regulations 2017 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

nurse practitioner, for chapter 11 and chapter 12, does not include a person holding limited or provisional registration to practise as a nurse practitioner.

opioid dependency treatment guidelines means the guidelines approved under section 630 (Guidelines for treatment of opioid dependency).

opioid dependency treatment licence—see section 600.

optical device, for chapter 22 (Therapeutic goods)—see section 800.

paramedic—

means a person holding registration to practise in the paramedicine profession under the Health Practitioner Regulation National Law (ACT); but

does not include a person holding student, limited or provisional registration for the purpose of undertaking a period of supervised practice or course of training, or both, to allow the person to be registered to practise without supervision.

personal custody, of a key by a person, for part 11.4 (Additional storage requirements for controlled medicines)—see section 530.

pharmaceutical benefit—see the National Health Act 1953 (Cwlth), section 84 (1), as in force from time to time.

Note The National Health Act 1953 (Cwlth) does not need to be notified under the Legislation Act because s 47 (6) does not apply (see s 863).

pharmaceutical benefits scheme means the scheme for the supply of pharmaceutical benefits established under the National Health Act 1953 (Cwlth), part 7.

pharmacist does not include an intern pharmacist.

Note See the definition of intern.

pharmacy medicines rural communities licence—see section 600.

prescribed person, for chapter 11 (Storage of medicines)—see section 510.

prescriber, in relation to a medicine, means the following:

a person in relation to whom prescribing the medicine is included in schedule 1, column 3 in relation to the person;

an endorsed health practitioner if prescribing the medicine is—

in accordance with the endorsement of their registration; and

if not inconsistent with the endorsement of their registration—allowed under this regulation.

prescription, in relation to an optical device, for chapter 22 (Therapeutic Goods)—see section 800.

Note Prescription, in relation to a medicine—see the Act, dictionary.

prohibited substance, for chapter 21 (Prohibited and schedule 10 substances)—see section 760.

prohibited substances register means a register for prohibited substances.

prohibited substances research and education program licence—see section 761.

pseudoephedrine record—see section 171 (c).

recognised research institution—see the Act, section 20 (5).

relevant expiry date, for a medicine, means—

if the medicine is from 1 batch—the expiry date for the batch; or

if the medicine is from more than 1 batch—the expiry date that is closest to the date of dispensing.

relevant law—

for chapter 16 (Low and moderate harm poisons)—see section 660; and

for part 19.3 (Packaging and labelling of dangerous poisons)—see section 730.

requisition includes issue a requisition.

reviewable decision, for chapter 23 (Notification and review of decisions)—see section 850.

retail sale, for division 4.2.7 (Selling pseudoephedrine by retail)—see section 170.

schedule 1—a reference to schedule 1 includes a reference to a provision of the schedule.

scientifically qualified person means—

a dentist, doctor, pharmacist, or veterinary practitioner; or

a person who has been awarded a doctorate for scientific studies by the person.

Note Dentist, doctor and pharmacist does not include an intern or trainee (see defs of these terms).

scope of employment includes scope of engagement as a contractor.

specialist means—

a person holding specialist registration to practise in the medical profession under the Health Practitioner Regulation National Law (ACT); or

a person holding limited or provisional registration to practise in the medical profession under the Health Practitioner Regulation National Law (ACT), for the purpose of undertaking a period of supervised practice under the supervision of a person mentioned in paragraph (a), the successful completion of which means that the person is eligible for specialist registration under that Law.

specialist area means a recognised specialty in a health profession under the Health Practitioner Regulation National Law (ACT).

terminal illness—a person has a terminal illness if a specialist diagnoses the person as having a terminal illness and estimates the person’s life expectancy to be less than 1 year.

Note Specialist includes a doctor training in a specialist area (see def specialist).

trainee, in relation to a health practitioner (other than a doctor or pharmacist), means a person holding limited or provisional registration to practise in a health profession under the Health Practitioner Regulation National Law (ACT) for the purpose of undertaking a period of supervised practice or course of training, or both, to allow the person to be registered to practise without supervision.

Examples—references to trainee

 trainee dentist

 trainee nurse

Note For doctors and pharmacists, see the definition of intern.

veterinary practitioner means a registered veterinary practitioner under the Veterinary Practice Act 2018, section 9.

walk-in centre means a non-residential facility operated by the Territory for the treatment and care for people with minor illness or injury.

young detainee—see the Children and Young People Act 2008, section 95.