Medicines, Poisons and Therapeutic Goods Regulation 2008

Number: SL2008-42
Made under: Medicines, Poisons and Therapeutic Goods Act 2008, s 184
Status: In Force

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Current law
Instruments
Point-in-time versions
Law history

Current version

Notes

Uncommenced amendments by Medicines, Poisons and Therapeutic Goods Amendment Regulation 2023 (No 3).

Effective	Files/Formats	Version	Published	Notes
30 September 2023	HTML PDF Word	R49	30 September 2023	Republication for expiry of provisions (pt 9.7)

Legislative instruments

Current legislative instruments under this subordinate law.

Name	Status	Classifier	Type	Under	Effective	Year and No
Medicines, Poisons and Therapeutic Goods (Guidelines for Treatment of Opioid Dependency) Approval 2010 (No 1)(Repealed)	Repealed		Notifiable instruments	s 630	15 January 2010 - 20 February 2018	NI2010-5
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2010 (No 1)(Repealed)	Repealed	Appointment	Disallowable instruments	s 635	25 June 2010 - 24 June 2013	DI2010-132
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2013 (No 1)(Repealed)	Repealed		Notifiable instruments	s 864	30 January 2013 - 13 May 2013	NI2013-41
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2013 (No 2)(Repealed)	Repealed		Notifiable instruments	s 864	14 May 2013 - 7 July 2020	NI2013-218
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2013 (No 1)(Repealed)	Repealed	Appointment	Disallowable instruments	s 635	5 November 2013 - 23 January 2014	DI2013-270
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2014 (No 1)(Repealed)	Repealed	Appointment	Disallowable instruments	s 635	24 January 2014 - 23 January 2017	DI2014-4
Medicines, Poisons and Therapeutic Goods (CHO Decisions on Applications) Guidelines 2014 (No 1)(Repealed)	Repealed		Notifiable instruments	s 574	12 August 2014 - 14 September 2016	NI2014-375
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2015 (No 1)(Repealed)	Repealed	Appointment	Disallowable instruments	s 635	14 February 2015 - 13 February 2018	DI2015-20
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2015 (No 1)(Repealed)	Repealed		Notifiable instruments	s 864	2 June 2015 - 2 December 2015	NI2015-231
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2015 (No 2)(Repealed)	Repealed		Notifiable instruments	s 864	5 June 2015 - 9 November 2015	NI2015-235
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2015 (No 3)(Repealed)	Repealed		Notifiable instruments	s 864	16 October 2015 - 15 April 2016	NI2015-586
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2015 (No 4)(Repealed)	Repealed		Notifiable instruments	s 864	10 November 2015 - 10 November 2018	NI2015-628
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2016 (No 1)(Repealed)	Repealed		Disallowable instruments	s 352	3 March 2016 - 21 March 2016	DI2016-12
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2016 (No 2)(Repealed)	Repealed		Disallowable instruments	s 352	22 March 2016 - 29 August 2016	DI2016-21
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2016 (No 1)(Repealed)	Repealed		Notifiable instruments	s 864	15 April 2016 - 15 October 2016	NI2016-184
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2016 (No 3)(Repealed)	Repealed		Disallowable instruments	s 352	30 August 2016 - 21 June 2017	DI2016-248
Medicines, Poisons and Therapeutic Goods (Category Approval) Determination 2016 (No 1)(Repealed)	Repealed		Notifiable instruments	s 574 and s 575	15 September 2016 - 19 January 2017	NI2016-522
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2016 (No 2)(Repealed)	Repealed		Notifiable instruments	s 864	8 October 2016 - 8 April 2017	NI2016-553
Medicines, Poisons and Therapeutic Goods (Category Approval) Determination 2017 (No 1)(Repealed)	Repealed		Notifiable instruments	s 575	20 January 2017 - 26 September 2017	NI2017-18
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2017 (No 1)(Repealed)	Repealed	Appointment	Disallowable instruments	s 635	8 March 2017 - 7 March 2020	DI2017-23
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2017 (No 2)(Repealed)	Repealed	Appointment	Notifiable instruments	s 635	8 March 2017 - 7 March 2020	NI2017-111
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2017 (No 3)(Repealed)	Repealed	Appointment	Notifiable instruments	s 635	8 March 2017 - 7 March 2020	NI2017-112
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2017 (No 1)(Repealed)	Repealed		Notifiable instruments	s 864	6 June 2017 - 6 December 2017	NI2017-284
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2017 (No 1)(Repealed)	Repealed		Disallowable instruments	s 352	22 June 2017 - 15 April 2019	DI2017-116
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2017 (No 2)(Repealed)	Repealed		Notifiable instruments	s 864	27 June 2017 - 26 June 2020	NI2017-331
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2017 (No 4)(Repealed)	Repealed		Notifiable instruments	s 864	1 August 2017 - 1 February 2018	NI2017-402
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2017 (No 3)(Repealed)	Repealed		Notifiable instruments	s 864	1 August 2017 - 1 February 2018	NI2017-405
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2017 (No 5)(Repealed)	Repealed		Notifiable instruments	s 864	14 September 2017 - 14 March 2018	NI2017-483
Medicines, Poisons and Therapeutic Goods (Category Approval) Determination 2017 (No 2)(Repealed)	Repealed		Notifiable instruments	s 575	27 September 2017 - 26 October 2017	NI2017-500
Medicines, Poisons and Therapeutic Goods (Category Approval) Determination 2017 (No 3)(Repealed)	Repealed		Notifiable instruments	s 575	27 October 2017 - 20 February 2018	NI2017-559
Medicines, Poisons and Therapeutic Goods (Category Approval) Determination 2018 (No 1)(Repealed)	Repealed		Notifiable instruments	s 575	21 February 2018 - 2 October 2018	NI2018-77
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2018 (No 1)(Repealed)	Repealed	Appointment	Disallowable instruments	s 635	21 February 2018 - 20 February 2021	DI2018-26
Medicines, Poisons and Therapeutic Goods (Guidelines for Treatment of Opioid Dependency) Approval 2018 (No 1)	None		Notifiable instruments	s 630	21 February 2018	NI2018-81
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2018 (No 2)(Repealed)	Repealed	Appointment	Disallowable instruments	s 635	3 May 2018 - 2 May 2021	DI2018-78
Medicines, Poisons and Therapeutic Goods (Category Approval) Determination 2018 (No 2)(Repealed)	Repealed		Notifiable instruments	s 575	3 October 2018 - 21 October 2019	NI2018-545
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Declaration 2018 (No 1)(Repealed)	Repealed		Notifiable instruments	s 864	18 December 2018 - 26 June 2020	NI2018-711
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2019 (No 1)(Repealed)	Repealed		Disallowable instruments	s 352	16 April 2019 - 6 April 2020	DI2019-42
Medicines, Poisons and Therapeutic Goods (Category Approval) Determination 2019 (No 1)(Repealed)	Repealed		Notifiable instruments	s 575	22 October 2019 - 11 June 2020	NI2019-663
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2020 (No 1)(Repealed)	Repealed		Disallowable instruments	s 352	7 April 2020 - 4 May 2020	DI2020-36
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2020 (No 2)(Repealed)	Repealed		Disallowable instruments	s 352	5 May 2020 - 8 June 2021	DI2020-88
Medicines, Poisons and Therapeutic Goods (Category Approval) Determination 2020 (No 1)(Repealed)	Repealed		Notifiable instruments	s 575	12 June 2020 - 25 January 2021	NI2020-322
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Revocation 2020 (No 1)(Repealed)	Repealed		Notifiable instruments	s 864	26 June 2020 - 27 June 2020	NI2020-347
Medicines, Poisons and Therapeutic Goods (Public Event for Kava Exemption) Revocation 2020 (No 2)(Repealed)	Repealed		Notifiable instruments	s 864	7 July 2020 - 8 July 2020	NI2020-389
Medicines, Poisons and Therapeutic Goods (Category Approval) Determination 2021 (No 1)(Repealed)	Repealed		Notifiable instruments	s 575	26 January 2021 - 1 April 2021	NI2021-39
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2021 (No 3)	None	Appointment	Notifiable instruments	s 635	21 February 2021 - 20 February 2024	NI2021-89
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2021 (No 1)	None	Appointment	Disallowable instruments	s 635	21 February 2021 - 20 February 2024	DI2021-34
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2021 (No 2)	None	Appointment	Disallowable instruments	s 635	3 May 2021 - 21 February 2024	DI2021-35
Medicines, Poisons and Therapeutic Goods Controlled Medicines Prescribing Standards 2021 (No 1)(Repealed)	Repealed		Notifiable instruments	s 575	2 April 2021 - 17 August 2023	NI2021-161
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2021 (No 1)(Repealed)	Repealed		Disallowable instruments	s 352	9 June 2021 - 9 August 2021	DI2021-111
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2021 (No 2)(Repealed)	Repealed		Disallowable instruments	s 352	10 August 2021 - 16 August 2021	DI2021-205
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2021 (No 3)(Repealed)	Repealed		Disallowable instruments	s 352	17 August 2021 - 16 December 2021	DI2021-207
Medicines, Poisons and Therapeutic Goods (COVID-19 Vaccine Administration) Approval 2021 (No 1)(Repealed)	Repealed		Notifiable instruments	s 491	24 August 2021 - 27 September 2021	NI2021-506
Medicines, Poisons and Therapeutic Goods (COVID-19 Vaccine Administration) Approval 2021 (No 2)	None		Notifiable instruments	s 491	28 September 2021	NI2021-569
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2021 (No 4)(Repealed)	Repealed		Disallowable instruments	s 352	17 December 2021 - 7 June 2022	DI2021-287
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2022 (No 1)(Repealed)	Repealed		Disallowable instruments	s 354	8 June 2022 - 16 March 2023	DI2022-77
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2023 (No 1)	None		Disallowable instruments	s 352	17 March 2023	DI2023-20
Medicines, Poisons and Therapeutic Goods (Medicines Advisory Committee) Appointment 2023 (No 1)	None	Appointment	Notifiable instruments	s 635	28 July 2023 - 21 February 2024	NI2023-432
Medicines, Poisons and Therapeutic Goods (Controlled Medicines Exempt from Standing Approvals) Declaration 2023 (No 1)	None		Notifiable instruments	s 556A	18 August 2023	NI2023-494
Medicines, Poisons and Therapeutic Goods Controlled Medicines Prescribing Standards 2023 (No 1)	None		Notifiable instruments	s 575	18 August 2023	NI2023-495
Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2023 (No 2)	None		Disallowable instruments	s 352	12 December 2023	DI2023-294

Point-in-time versions

Enter a date to find a version from 14 February 2009 onwards:

The following table lists 49 point in time versions. You can skip this and jump to the next tab.
Effective	Files/Formats	Version	Published	Notes
30 September 2023	HTML PDF Word	R49	30 September 2023	Republication for expiry of provisions (pt 9.7)
8 August 2023 - 29 September 2023	HTML PDF Word	R48	8 August 2023	Republication for amendments by SL2023-17
3 July 2023 - 7 August 2023	HTML PDF Word	R47	3 July 2023	Republication for amendments by A2023-17
7 April 2023 - 2 July 2023	HTML PDF Word	R46	7 April 2023	Republication for amendments by SL2023-5
1 October 2022 - 6 April 2023	HTML PDF Word	R45	1 October 2022	Republication for expiry of provision (s 632)
5 November 2021 - 30 September 2022	HTML PDF Word	R44	5 November 2021	Republication for amendments by SL2021-28
18 August 2021 - 4 November 2021	HTML PDF Word	R43	18 August 2021	Republication for amendments by SL2021-19
23 June 2021 - 17 August 2021	HTML PDF Word	R42	23 June 2021	Republication for amendments by A2021-12
10 September 2020 - 22 June 2021	HTML PDF Word	R41	10 September 2020	Republication for amendments by SL2020-39
21 August 2020 - 9 September 2020	HTML PDF Word	R40	21 August 2020	Republication for amendments by SL2020-31
27 June 2020 - 20 August 2020	HTML PDF Word	R39	27 June 2020	Republication for amendments by SL2020-24
20 June 2020 - 26 June 2020	HTML PDF Word	R38	20 June 2020	Republication for amendments by SL2020-21
8 April 2020 - 19 June 2020	HTML PDF Word	R37	8 April 2020	Republication for amendments by A2020-11
4 April 2020 - 7 April 2020	HTML PDF Word	R36	4 April 2020	Republication for amendments by SL2020-13
21 January 2020 - 3 April 2020	HTML PDF Word	R35	21 January 2020	Republication for amendments by SL2020-3
13 September 2019 - 20 January 2020	HTML PDF Word	R34	13 September 2019	Republication for amendments by SL2019-23
21 December 2018 - 12 September 2019	HTML PDF Word	R33	21 December 2018	Republication for amendments by A2018-32
22 November 2018 - 20 December 2018	HTML PDF Word	R32	22 November 2018	Republication for amendments by A2018-42
15 June 2018 - 21 November 2018	HTML PDF Word	R31	15 June 2018	Republication for amendments by A2018-23
25 August 2017 - 14 June 2018	HTML PDF Word	R30	25 August 2017	Republication for amendments by SL2017-27
29 August 2016 - 24 August 2017	HTML PDF Word	R29	29 August 2016	Republication for amendments by A2016-7
31 July 2016 - 28 August 2016	HTML PDF Word	R28	31 July 2016	Republication for amendments by SL2016-16
1 March 2016 - 30 July 2016	HTML PDF Word	R27	1 March 2016	Republication for amendments by A2015-38 and SL2016-5
9 December 2015 - 29 February 2016	HTML PDF Word	R26	9 December 2015	Republication for amendments by A2015-50
1 December 2015 - 8 December 2015	HTML PDF Word	R25	1 December 2015	Republication for amendments by A2015-29
24 November 2015 - 30 November 2015	HTML PDF Word	R24	24 November 2015	Republication for amendments by SL2015-36
21 July 2015 - 23 November 2015	HTML PDF Word	R23	21 July 2015	Republication for amendments by SL2015-19
22 May 2015 - 20 July 2015	HTML PDF Word	R22	22 May 2015	Republication for amendments by SL2015-19
23 October 2014 - 21 May 2015	HTML PDF Word	R21	23 October 2014	Republication for amendments by SL2014-26
1 October 2014 - 22 October 2014	HTML PDF Word	R20	1 October 2014	Republication for amendments by SL2014-23
26 September 2014 - 30 September 2014	HTML PDF Word	R19	26 September 2014	Republication for amendments by SL2014-23
25 November 2013 - 25 September 2014	HTML PDF Word	R18	25 November 2013	Republication for relocation of provisions from Medicines, Poisons and Therapeutic Goods Act 2008 and other amendments by A2013-44
5 November 2013 - 24 November 2013	HTML PDF Word	R17	5 November 2013	Republication for amendments by SL2013-28
1 September 2013 - 4 November 2013	HTML PDF Word	R16	1 September 2013	Republication for amendments by SL2013-24
26 January 2013 - 31 August 2013	HTML PDF Word	R15	26 January 2013	Republication for amendments by SL2013-1
3 August 2012 - 25 January 2013	HTML PDF Word	R14	3 August 2012	Republication for amendments by SL2012-34
13 February 2012 - 2 August 2012	HTML PDF Word	R13	13 February 2012	Republication for expiry of provision (s 864)
10 February 2012 - 12 February 2012	HTML PDF Word	R12	10 February 2012	Republication for amendments by SL2012-5
12 December 2011 - 9 February 2012	HTML PDF Word	R11	12 December 2011	Republication for amendments by A2011-52
21 December 2010 - 11 December 2011	HTML PDF Word	R10	21 December 2010	Republication for amendments by A2010-50
1 December 2010 - 20 December 2010	HTML PDF Word	R9	1 December 2010	Republication for amendments by A2010-43
23 November 2010 - 30 November 2010	HTML PDF Word	R8	23 November 2010	Republication for amendments by SL2010-45
1 July 2010 - 22 November 2010	HTML PDF Word	R7	1 July 2010	Republication for amendments by A2010-10, SL2010-16 and SL2010-20
11 May 2010 - 30 June 2010	HTML PDF Word	R6	11 May 2010	Republication for amendments by SL2010-16
1 April 2010 - 10 May 2010	HTML PDF Word	R5	1 April 2010	Republication for commenced expiry
22 January 2010 - 31 March 2010	HTML PDF Word	R4	22 January 2010	Republication for amendments by SL2010-1 and SL2010-2
17 December 2009 - 21 January 2010	HTML PDF Word	R3	17 December 2009	Republication for amendments by A2009-49
6 June 2009 - 16 December 2009	HTML PDF Word	R2	6 June 2009	Republication for amendments by SL2009-27
14 February 2009 - 5 June 2009	HTML PDF Word	R1	14 February 2009	Republication for new regulation
14 February 2009	HTML PDF Word	As notified	15 September 2008

Notification statement

The Medicines, Poisons and Therapeutic Goods Regulation 2008 has been made and is notified under the Legislation Act 2001.

Notified: 15 September 2008 (Parliamentary Counsel)

Instrument as notified

Date notified	Effective	Files/Formats	Notes
15 September 2008	14 February 2009	HTML PDF Word

Explanatory statement

Version	Published	Files/Formats
As presented	15 September 2008	HTML PDF Word

Commencement

Provision	Commencement date	Commencement method
s 1, s 2	15 September 2008	LA s 75 (1)
remainder	14 February 2009	s 2 and see A2008-26, s 2 and LA s 79

Expiries

Expiry information is being progressively added to the Legislation Register, for a full list of expired provisions in this law see the amendment history in the endnotes in the current version of this law.

Provision	Expiry date	Expiry method
pt 9.7	29 September 2023 (midnight)	expires at the end of a 12-month period during which no COVID-19 emergency has been in force (s 492)
s 632	30 September 2022 (midnight)	expired on the first day no COVID-19 emergency was in force (s 632 (3))

Amendments

For section-by-section amendment annotations, see the amendment history in the endnotes in the current version of this law.

Amendment information is being progressively added to the Legislation Register. For a full list of legislation amending this law, see the legislation history in the endnotes in the current version of this law.

Year and number	Amending law	Amending provision	Commencement date
SL2020-13	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2020 (No 1)	s 4	4 April 2020
A2020-11	COVID-19 Emergency Response Act 2020	sch 1 pt 1.14	8 April 2020
SL2020-21	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2020 (No 2)	ss 4-7	20 June 2020
SL2020-24	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2020 (No 3)	ss 4-6	27 June 2020
SL2009-27	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2009 (No 1)	ss 4-8	6 June 2009
SL2020-31	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2020 (No 4)	s 4	21 August 2020
SL2020-39	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2020 (No 5)	ss 4-13	10 September 2020
A2021-12	Statute Law Amendment Act 2021	sch 3 pt 3.36	23 June 2021
SL2021-19	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 1)	s 4	18 August 2021
SL2021-28	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 2)	ss 4-26	5 November 2021
SL2009-27	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2009 (No 1)	s 6	6 June 2009
SL2023-5	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2023 (No 1)	ss 4-7	7 April 2023
A2023-17	Health Infrastructure Enabling Act 2023	sch 2 pt 2.3	3 July 2023
SL2023-17	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2023 (No 2)	s 4	8 August 2023
SL2023-34	Medicines, Poisons and Therapeutic Goods Amendment Regulation 2023 (No 3)	ss 4-11	commences 12 December 2023