Australian Capital Territory Consolidated Regulations

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MEDICINES, POISONS AND THERAPEUTIC GOODS REGULATION 2008 - NOTES

- made under the Medicines, Poisons and Therapeutic Goods Act 2008

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:

              •     child

              •     correctional centre

              •     doctor

              •     enrolled nurse

              •     home address

              •     nurse

              •     nurse practitioner

              •     optometrist

              •     public employee

              •     reviewable decision notice.

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:

              •     controlled medicine (see s 11)

              •     dangerous poison (see s 12)

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

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

              •     health practitioner

              •     hospital

              •     institution

              •     medicines and poisons standard (see s 15)

              •     prescription only medicine (see s 11)

              •     prohibited substance (see s 13)

              •     purchase order

              •     regulated substance (see s 10)

              •     residential aged care facility

              •     signs

              •     supply (see s 24)

              •     supply authority (see s 23)

              •     ward

              •     written.

"appendix D medicines approval"—see section 590.

"approved analyst" means—

        (a)     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

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

Australian code of good wholesaling practice for therapeutic goods for human use means the Australian Code of Good Wholesaling Practice for Therapeutic Goods for Human Use prepared by the National Coordinating Committee on Therapeutic Goods, as in force from time to time.

Note     The code 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.

"CHO" means chief health officer.

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

"complying purchase order" means—

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

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

        (c)     for an appendix C substance or prohibited substance—see section 772.

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

condition 2, for a doctor prescribing or supplying a designated appendix D medicine to a woman of child-bearing age, for schedule 3—see schedule 3, section 3.1.

condition 3, for a doctor prescribing or supplying a designated appendix D medicine to a woman of child-bearing age, for schedule 3—see schedule 3, section 3.1.

condition 4, for a doctor prescribing or supplying a designated appendix D medicine to a woman of child-bearing age, for schedule 3—see schedule 3, section 3.1.

"controlled medicines approval"—see section 550.

"controlled medicines register" means a register for controlled medicines.

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

"custodian", of an animal, means—

        (a)     an adult who has lawful custody of the animal; or

        (b)     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.

"day hospital "means a facility where a person is admitted for surgical or medical treatment and discharged on the same day.

"dentist" does not include a trainee dentist.

Note     See the definition of trainee.

"designated appendix D medicine" means a medicine listed in schedule 3, (Designated appendix D medicines—standing approvals), part 3.2, column 3.

Note     The medicines are included in the medicines and poisons standard, appendix D.

"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—

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

        (b)     meals and cleaning services; and

        (c)     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.

"eligible midwife"—see the National Health Act 1953 (Cwlth), section 84AAE.

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

"environmental authorisation" means—

        (a)     an environmental authorisation under the Environment Protection Act 1997; or

        (b)     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.

"health profession" means—

        (a)     a health profession under the Health Practitioner Regulation National Law (ACT), section 5 (Definitions); and

        (b)     includes a health profession under the Health Professionals Act 2004, dictionary.

"health professional" means a person who is registered under the Health Professionals Act 2004.

"in-patient", at an institution, includes—

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

        (b)     for a correctional centre—a detainee; and

        (c)     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—

        (a)     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

        (b)     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 practice without supervision.

"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.

Note     See the definition of primary pack.

"medical records" includes—

        (a)     for a person at an institution—the person's clinical records and a medication chart for the person at the institution; and

        (b)     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 code is accessible at www.medicinesaustralia.com.au.

"medicines wholesalers licence"—see section 600.

"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.

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

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

"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.

"primary pack" means the pack in which a regulated substance and its immediate container or immediate wrapper or measure pack are presented for sale or supply.

Note     This is the same as the definition in the medicines and poisons standard, par 1 (l), and is included because of its relationship to the meaning of manufacturer's pack. Other terms defined in the standard have the same meaning in this regulation, see the Act, s 16 (1).

"prohibited substance", for chapter 21 (Prohibited and appendix C 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—

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

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

"relevant law"—

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

        (b)     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)     a dentist, doctor, pharmacist, or veterinary surgeon; or

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

Note     Dentist, doctor, pharmacist and "veterinary surgeon" 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)     a person holding specialist registration to practise in the medical profession under the Health Practitioner Regulation National Law (ACT); or

        (b)     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", for a health profession, means—

        (a)     a recognised speciality under the Health Practitioner Regulation National Law (ACT); or

        (b)     a specialist area under the Health Professionals Regulation 2004.

"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 practice without supervision.

Examples—references to trainee

trainee dentist, trainee nurse and trainee veterinary surgeon

Note 1     For doctors and pharmacists, see the definition of intern.

Note 2     An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).

"veterinary surgeon" does not include a trainee veterinary surgeon.

Note     See the definition of trainee.

"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.

Endnotes

1     About the endnotes

Amending and modifying laws are annotated in the legislation history and the amendment history. Current modifications are not included in the republished law but are set out in the endnotes.

Not all editorial amendments made under the Legislation Act 2001, part 11.3 are annotated in the amendment history. Full details of any amendments can be obtained from the Parliamentary Counsel's Office.

Uncommenced amending laws are not included in the republished law. The details of these laws are underlined in the legislation history. Uncommenced expiries are underlined in the legislation history and amendment history.

If all the provisions of the law have been renumbered, a table of renumbered provisions gives details of previous and current numbering.

The endnotes also include a table of earlier republications.

2     Abbreviation key

A = Act

NI = Notifiable instrument

AF = Approved form

o = order

am = amended

om = omitted/repealed

amdt = amendment

ord = ordinance

AR = Assembly resolution

orig = original

ch = chapter

par = paragraph/subparagraph

CN = Commencement notice

pres = present

def = definition

prev = previous

DI = Disallowable instrument

(prev...) = previously

dict = dictionary

pt = part

disallowed = disallowed by the Legislative

r = rule/subrule

Assembly

reloc = relocated

div = division

renum = renumbered

exp = expires/expired

R[X] = Republication No

Gaz = gazette

RI = reissue

hdg = heading

s = section/subsection

IA = Interpretation Act 1967

sch = schedule

ins = inserted/added

sdiv = subdivision

LA = Legislation Act 2001

SL = Subordinate law

LR = legislation register

sub = substituted

LRA = Legislation (Republication) Act 1996

underlining = whole or part not commenced

mod = modified/modification

or to be expired

3     Legislation history

Medicines, Poisons and Therapeutic Goods Regulation 2008 SL2008-42

notified LR 15 September 2008

s 1, s 2 commenced 15 September 2008 (LA s 75 (1))

remainder commenced 14 February 2009 (s 2 and see Medicines, Poisons and Therapeutic Goods Act 2008 A2008-26, s 2 and LA s 79)

as amended by

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2009 (No 1) SL2009-27

notified LR 5 June 2009

s 1, s 2 commenced 5 June 2009 (LA s 75 (1))

remainder commenced 6 June 2009 (s 2)

Statute Law Amendment Act 2009 (No 2) A2009-49 sch 3 pt 3.51

notified LR 26 November 2009

s 1, s 2 commenced 26 November 2009 (LA s 75 (1))

sch 3 pt 3.51 commenced 17 December 2009 (s 2)

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2010 (No 1) SL2010-1

notified LR 21 January 2010

s 1, s 2 commenced 21 January 2010 (LA s 75 (1))

remainder commenced 22 January 2010 (s 2)

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2010 (No 2) SL2010-2

notified LR 21 January 2010

s 1, s 2 commenced 21 January 2010 (LA s 75 (1))

remainder commenced 22 January 2010 (s 2)

Health Practitioner Regulation National Law (ACT) Act 2010 A2010-10 sch 2 pt 2.15

notified LR 31 March 2010

s 1, s 2 commenced 31 March 2010 (LA s 75 (1))

sch 2 pt 2.15 commenced 1 July 2010 (s 2 (1) (a))

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2010 (No 3) SL2010-16

notified LR 10 May 2010

s 1, s 2 commenced 10 May 2010 (LA s 75 (1))

sch 1 commenced 1 July 2010 (s 2 (2) and see Health Practitioner Regulation National Law (ACT) Act 2010 A2010-10 s 2 (1) (a))

remainder commenced 11 May 2010 (s 2 (1))

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2010 (No 4) SL2010-20

notified LR 3 June 2010

s 1, s 2 commenced 3 June 2010 (LA s 75 (1))

remainder commenced 1 July 2010 (s 2 and see Health Practitioner Regulation National Law (ACT) Act 2010 A2010-10 s 2 (1) (a))

Liquor (Consequential Amendments) Act 2010 A2010-43 sch 1 pt 1.14

notified LR 8 November 2010

s 1, s 2 commenced 8 November 2010 (LA s 75 (1))

sch 1 pt 1.14 commenced 1 December 2010 (s 2 (4) and see Liquor Act 2010 A2010-35, s 2 (3) (as am by A2010-43 amdt 1.19) and CN2010-14)

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2010 (No 5) SL2010-45

notified LR 22 November 2010

s 1, s 2 commenced 22 November 2010 (LA s 75 (1))

remainder commenced 23 November 2010 (s 2)

Justice and Community Safety Legislation Amendment Act 2010 (No 4) A2010-50 sch 1 pt 1.6

notified LR 14 December 2010

s 1, s 2 commenced 14 December 2010 (LA s 75 (1))

sch 1 pt 1.6 commenced 21 December 2010 (s 2 (1))

Statute Law Amendment Act 2011 (No 3) A2011-52 sch 1 pt 1.5

notified LR 28 November 2011

s 1, s 2 commenced 28 November 2011 (LA s 75 (1))

sch 1 pt 1.5 commenced 12 December 2011 (s 2)

Medicines, Poisons and Therapeutic Goods Amendment Regulation 2012 (No 1) SL2012-5

notified LR 9 February 2012

s 1, s 2 commenced 9 February 2012 (LA s 75 (1))

remainder commenced 10 February 2012 (s 2)

4     Amendment history

Commencement
s 2     om LA s 89 (4)

General overview of authorisations for medicines
s 10     am A2010-10 amdt 2.85

Overview of medicines authorisations under this regulation
s 11     am SL2010-2 s 4; pars renum R4 LA

Relationship with registration laws
pt 2.2 hdg     sub A2010-10 amdt 2.86

Medicines authorisations subject to Health Practitioner Regulation National Law (ACT) restrictions
s 20     sub A2010-10 amdt 2.86

Medicines authorisations subject to Health Professionals Act restrictions
s 21     ins A2010-10 amdt 2.86

Authorisation under sch 1 to prescribe medicines—Act, s 40 (1) (b), (2) (b) and (3) (b)
s 30     am SL2010-45 s 4

Particulars for prescriptions
s 41     am SL2010-1 s 4; SL2010-45 s 5; pars renum R8 LA

Standing orders for walk-in centre
div 3.4.3 hdg     ins SL2010-2 s 5

Authorisation of CHO to issue standing orders for supply and administration of medicines at walk-in centre—Act, s 42 (b)
s 77     ins SL2010-2 s 5

Particulars for CHO standing orders for supply and administration of medicines at walk-in centre
s 78     ins SL2010-2 s 5

Authorisation under sch 1 to supply medicines—Act, s 26 (1) (b) and (2) (b)
s 110     am A2010-10 amdt 2.87

How medicines are dispensed
s 121     am A2010-10 amdt 2.88, amdt 2.89

Labelling dispensed medicines—Act, s 60 (1) (c) (i) and (2) (c) (i)
s 123     am SL2010-45 s 6; pars renum R8 LA

Labelling medicines supplied during consultations
s 161     am SL2010-45 s 7; pars renum R8 LA

Required information for pseudoephedrine sales records
s 173     am A2010-43 amdt 1.57

Authorisation for self-administration etc of medicines—Act, s 37 (2) (b) and (3) (b)
s 360     am SL2010-45 s 8

Authorisations to deliver medicines under supply authorities—Act, s 26 (1) (b), (2) (b), s 35 (1) (b), (2) (b) and s 36 (b)
s 400     am A2010-10 amdts 2.90-2.92

When pharmacy medicines and pharmacist only medicines to be supplied in manufacturer's packs—Act, s 59 (1) (c) (i) and (2) (c) (i)
s 500     am A2010-10 amdt 2.93

Meaning of prescribed person—ch 11
s 510     am SL2010-16 s 4, s 5, amdt 1.1; SL2010-45 s 9

Storage of controlled medicines for certain health-related occupations—Act, s 61 (b) and (c)
s 532     am SL2010-16 s 6, s 7, amdt 1.1

Storage of controlled medicines by certain other prescribed people—Act, s 61 (b) and (c)
s 533     am SL2010-16 s 8

Keeping of controlled medicines registers by certain people—Act, s 48 (a) and s 50 (1) (b) and (2) (b)
s 540     table 540 am SL2010-16 s 9

Keeping of controlled medicines registers by first-aid kit holders—Act, s 48 (a) and s 50 (1) (b) and (2) (b)
s 541     am SL2010-16 s 10, s 11, amdt 1.1

Prescribed witnesses for administration of controlled medicines—Act, s 53 (a) and (b)
s 544     am SL2010-20 s 4

Standing interim approval to prescribe buprenorphine and methadone for patients of certain institutions
s 557 hdg     sub SL2010-1 s 5
s 557     am SL2010-1 s 6; pars renum R4 LA

Restrictions on CHO power to approve applications for approvals
s 563     am SL2010-1 s 7

First-aid kit licences
pt 14.3 note     am A2010-10 amdt 2.104

Additional information for first-aid kit licences—Act, s 88 (1) (k)
s 612     am A2009-49 amdt 3.121

Medicines advisory committee—ending appointments
s 644     am A2011-52 amdt 1.8

Meaning of reviewable decision—ch 23
s 850     am SL2009-27 s 4

Reviewable decision notices
s 851     sub SL2009-27 s 5

Applications for review
s 852     sub SL2009-27 s 5

Other authorisations for public employees—Act, s 20 (1) (a), (2) (a) and s 74 (1) (b)
s 861     am SL2010-45 s 10

Exemption of piper methysticum (kava)—Act, s 190 (1) (a)
s 864     om LA s 89 (3)
    ins SL2012-5 s 4
    exp 12 February 2012 (s 864 (3))

Transitional
ch 30 hdg     exp 31 March 2010 (s 1008)

Definitions—ch 30
s 1000     exp 31 March 2010 (s 1008)
    def DODA exp 31 March 2010 (s 1008)
    def PADA exp 31 March 2010 (s 1008)

DODA wholesaler's licences—Act, s 520 (2)
s 1001     exp 31 March 2010 (s 1008)

Poisons Act licences—Act, s 520 (2)
s 1002     exp 31 March 2010 (s 1008)

PADA licences—Act, s 520 (2)
s 1003     exp 31 March 2010 (s 1008)

DODA authorisations—Act, s 522 (2)
s 1004     exp 31 March 2010 (s 1008)

PADA authorisations—Act, s 522 (2)
s 1005     exp 31 March 2010 (s 1008)

Public Health (Prohibited Drugs) Act authorisations—Act, s 522 (2)
s 1006     exp 31 March 2010 (s 1008)

DODA approvals to prescribe drugs of dependence—Act, s 531 (2)
s 1007     exp 31 March 2010 (s 1008)

Expiry—ch 30
s 1008     exp 31 March 2010 (s 1008)

Modification of Act
ch 31 hdg     ins SL2009-27 s 6
    om A2010-50 amdt 1.13

Modification of Act, ch 14—Act, s 501 (2)
s 1100     ins SL2009-27 s 6
    om A2010-50 amdt 1.13

Expiry—ch 31
s 1110     ins SL2009-27 s 6
    om A2010-50 amdt 1.13

Dentists, dental hygienists and dental therapists
sch 1 pt 1.2     am A2010-10 amdt 2.104

Doctors
sch 1 pt 1.3     am A2010-10 amdt 2.104

Health practitioners and health professionals at institutions
sch 1 pt 1.4     sub A2010-10 amdt 2.94

Midwives
sch 1 pt 1.5     am A2010-10 amdt 2.104; SL2010-45 s 11

Nurses
sch 1 pt 1.6     am SL2010-16 s 12; A2010-10 amdt 2.104; SL2010-20 s 5; items renum R7 LA

Opioid dependency treatment centres operated by Territory
sch 1 pt 1.7     am A2010-10 amdt 2.104

Optometrists
sch 1 pt 1.8     am A2010-10 amdt 2.95

Residential care facilities
sch 1 pt 1.11     am A2010-10 amdt 2.104

Optometry medicines
sch 2     am A2010-10 amdt 2.96

Designated appendix D medicines—standing approvals
sch 3     am SL2010-45 s 12

Health Professionals Regulation 2004
sch 6     om LA s 89 (3)

Modification—Crimes Act 1900
sch 10     ins SL2009-27 s 7
    om A2010-50 amdt 1.14

Dictionary
dict     am SL2009-27 s 8; A2009-49 amdt 3.122; A2010-10 amdt 2.97, amdt 2.98
    def authorised midwife ins SL2010-45 s 13
    def eligible midwife ins SL2010-45 s 13
    def enrolled nurse om SL2010-20 s 6
    def enrolled nurse (medications) sub A2010-10 amdt 2.99
    om SL2010-20 s 7
    def health profession sub A2010-10 amdt 2.100
    def intern sub A2010-10 amdt 2.101
    def nurse practitioner ins SL2010-16 s 13
    am SL2010-16 amdt 1.1
    def pharmaceutical benefits scheme ins SL2010-45 s 13
    def specialist sub A2010-10 amdt 2.102
    def specialist area sub A2010-10 amdt 2.102
    def trainee am A2010-10 amdt 2.103
    def walk-in centre ins SL2010-2 s 6

5     Earlier republications

Some earlier republications were not numbered. The number in column 1 refers to the publication order.

Since 12 September 2001 every authorised republication has been published in electronic pdf format on the ACT legislation register. A selection of authorised republications have also been published in printed format. These republications are marked with an asterisk (*) in column 1. Electronic and printed versions of an authorised republication are identical.

Republication No and date

Effective

Last amendment made by

Republication for

R1
14 Feb 2009

14 Feb 2009–
5 June 2009

not amended

new regulation

R2
6 June 2009

6 June 2009–
16 Dec 2009

SL2009-27

amendments by SL2009-27

R3
17 Dec 2009

17 Dec 2009–
21 Jan 2010

A2009-49

amendments by A2009-49

R4
22 Jan 2010

22 Jan 2010–
31 Mar 2010

SL2010-2

amendments by SL2010-1 and SL2010-2

R5
1 Apr 2010

1 Apr 2010–
10 May 2010

A2010-10

commenced expiry

R6
11 May 2010

11 May 2010–
30 June 2010

SL2010-16

amendments by SL2010-16

R7
1 July 2010

1 July 2010–
22 Nov 2010

SL2010-20

amendments by A2010-10, SL2010-16 and SL2010-20

R8
23 Nov 2010

23 Nov 2010–
30 Nov 2010

SL2010-45

amendments by SL2010-45

R9
1 Dec 2010

1 Dec 2010–
20 Dec 2010

SL2010-45

amendments by A2010-43

R10
21 Dec 2010

21 Dec 2010–
11 Dec 2011

A2010-50

amendments by A2010-50

R11
12 Dec 2011

12 Dec 2011–
9 Feb 2012

A2011-52

amendments by A2011-52

R12
10 Feb 2012

10 Feb 2012–
12 Feb 2012

SL2012-5

amendments by SL2012-5











© Australian Capital Territory 2012

ACT
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Australian Capital Territory

SL2008-42

Republication No 13

Effective: 13 February 2012

Republication date: 13 February 2012

Last amendment made by SL2012-5
(republication for expiry of provision (s 864))




Unauthorised version prepared by ACT Parliamentary Counsel's Office

About this republication

The republished law

This is a republication of the Medicines, Poisons and Therapeutic Goods Regulation 2008

, made under the Medicines, Poisons and Therapeutic Goods Act 2008

(including any amendment made under the Legislation Act 2001, part 11.3 (Editorial changes)) as in force on 13 February 2012

. It also includes any commencement, amendment, repeal or expiry affecting this republished law to 13 February 2012

.

The legislation history and amendment history of the republished law are set out in endnotes 3 and 4.

Kinds of republications

The Parliamentary Counsel's Office prepares 2 kinds of republications of ACT laws (see the ACT legislation register at www.legislation.act.gov.au):

              • authorised republications to which the Legislation Act 2001 applies

              • unauthorised republications.

The status of this republication appears on the bottom of each page.

Editorial changes

The Legislation Act 2001, part 11.3 authorises the Parliamentary Counsel to make editorial amendments and other changes of a formal nature when preparing a law for republication. Editorial changes do not change the effect of the law, but have effect as if they had been made by an Act commencing on the republication date (see Legislation Act 2001, s 115 and s 117). The changes are made if the Parliamentary Counsel considers they are desirable to bring the law into line, or more closely into line, with current legislative drafting practice.

This republication does not include amendments made under part 11.3 (see endnote 1).

Uncommenced provisions and amendments

If a provision of the republished law has not commenced, the symbol  U  appears immediately before the provision heading. Any uncommenced amendments that affect this republished law are accessible on the ACT legislation register (www.legislation.act.gov.au). For more information, see the home page for this law on the register.

Modifications

If a provision of the republished law is affected by a current modification, the symbol  M  appears immediately before the provision heading. The text of the modifying provision appears in the endnotes. For the legal status of modifications, see the Legislation Act 2001, section 95.

Penalties

At the republication date, the value of a penalty unit for an offence against this law is $110 for an individual and $550 for a corporation (see Legislation Act 2001, s 133).

ACT
Crest high res small
Australian Capital Territory

Medicines, Poisons and Therapeutic Goods Regulation 2008



Part 1.1Ambulance services and officers216

Part 1.2Dentists, dental hygienists and dental therapists217

Part 1.3Doctors220

Part 1.4Health professionals at institutions222

Part 1.5Midwives223

Part 1.6Nurses225

Part 1.7Opioid dependency treatment centres operated by Territory228

Part 1.8Optometrists229

Part 1.9Pharmacists and employees230

Part 1.10Podiatrists233

Part 1.11Residential care facilities234

Part 1.12Sales representatives for medicines manufacturers and wholesalers236

Part 1.13Veterinary surgeons and employees237

Part 3.1Approval conditions242

Part 3.2Standing approvals for designated appendix D medicines243

Part 5.1Medicines cabinets248

Part 5.2Safes, strong rooms and vaults250

Endnotes261

ACT
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Australian Capital Territory

Medicines, Poisons and Therapeutic Goods Regulation 2008




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