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Australian Capital Territory
Medicines, Poisons and Therapeutic
Goods Regulation 2008
SL2008-42
made under the
Medicines, Poisons and Therapeutic Goods Act 2008
Republication No 45
Effective: 1 October 2022
Republication date: 1 October 2022
Last amendment made by SL2021-28
(republication for expiry of provision (s 632))
Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au
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 1 October 2022. It
also includes any commencement, amendment, repeal or expiry affecting this republished law to
1 October 2022.
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 $160 for an
individual and $810 for a corporation (see Legislation Act 2001, s 133).
Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au
Australian Capital Territory
Medicines, Poisons and Therapeutic
Goods Regulation 2008
made under the
Medicines, Poisons and Therapeutic Goods Act 2008
Contents
Page
Chapter 1 Preliminary
1 Name of regulation 2
3 Dictionary 2
4 Notes 2
5 Offences against regulation—application of Criminal Code etc 3
6 Overview of things to which medicines and poisons standard does not
apply 3
R45 Medicines, Poisons and Therapeutic Goods contents 1
01/10/22 Regulation 2008
Effective: 01/10/22
Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au
Contents
Page
Chapter 2 Medicines—authorisations generally
Part 2.1 Overview of medicines authorisations
10 General overview of authorisations for medicines 5
11 Overview of medicines authorisations under this regulation 6
12 General overview of authorisation conditions for medicines 9
Part 2.2 Relationship with registration laws
20 Medicines authorisations subject to Health Practitioner Regulation
National Law (ACT) restrictions 10
21 Medicines authorisations subject to Veterinary Practice Act 2018
restrictions 10
Chapter 3 Medicines—supply authorities
Part 3.1 Prescribing medicines
Division 3.1.1 Authorisation to prescribe medicines
30 Authorisation under sch 1 to prescribe medicines—Act, s 40 (1) (b),
(2) (b) and (3) (b) 11
31 Authorisation conditions for prescribing medicines—Act, s 44 (1) (b)
and (2) (b) 12
31A Variation of authorisation condition during Commonwealth special
arrangement period 14
32 Additional requirements for prescribing controlled medicines for human
use 15
Division 3.1.2 Prescriptions
40 General requirements for written prescriptions 16
41 Particulars for prescriptions 16
Part 3.2 Requisitioning medicines
Division 3.2.1 Authorisation to issue requisitions
50 Authorisation under sch 1 to issue requisitions for medicines—Act,
s 41 (b) 19
51 Authorisation conditions for issuing requisitions for medicines—Act,
s 44 (1) (b) and (2) (b) 19
contents 2 Medicines, Poisons and Therapeutic Goods R45
Regulation 2008 01/10/22
Effective: 01/10/22
Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au
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