1Short title
This Act may be cited as the Medicines, Poisons and Therapeutic
Goods Act 2012.
Bills and explanatory statements from legislation.nt.gov.au; second reading speeches from the NT Parliamentary Record (Territory Stories). Links open the official source in a new tab.
Bill homepage (legislation.nt.gov.au)This Act may be cited as the Medicines, Poisons and Therapeutic
Goods Act 2012.
This Act commences on the day fixed by the Administrator by Gazette notice.
(1) The main object of this Act is to promote and protect public health and safety by minimising:
accidental and deliberate poisoning by Scheduled substances; and
misadventures by poisoning by Scheduled substances; and
(c) the manufacture of substances that are subject to abuse (substances of abuse); and
the diversion for abuse of substances of abuse; and
harm from therapeutic goods.
Other objects of this Act are to ensure:
(a) consumers of Schedule 4 and 8 substances have adequate information and the understanding necessary to allow them to administer the substances safely and effectively; and
(b) consumers of Schedule 2 and 3 substances have adequate information and the understanding to allow them to:
select the most appropriate substances for their condition; and
(ii) administer the substances safely and effectively, taking into account the condition of their health.
(1) The objects of this Act are primarily achieved by prohibiting and regulating people dealing with Scheduled substances.
(2) In general, under Part 2.1, only the holder of an authority issued under Chapter 3 may manufacture and, in some circumstances sell, Scheduled substances.
(3) In addition, under Part 2.2, only those authority holders, or health practitioners, veterinarians and others authorised under Part 2.3, may possess, supply or use Scheduled substances.
(4) Those general rules are subject to, or complemented by, special rules under Parts 2.4 to 2.8 about the following:
(a) the issue of prescriptions for the supply of Scheduled substances by health practitioners and veterinarians;
(b) the storage, packaging, labelling, advertisement, supply by vending machines, transport and destruction of Scheduled substances; and
(c) the manufacture, supply and use of paints containing Scheduled substances; and
(d) other circumstances in which dealing with Scheduled substances may be prohibited.
(5) Apart from prohibiting and regulating people dealing with Scheduled substances, Chapter 6 contributes to achieving the objects of this Act by adopting in the Territory a uniform Australian approach to the regulation of therapeutic goods.
(6) For the effective administration and enforcement of this Act, provision is made about the following:
codes of practice and exemptions;
the Scheduled Substances Clinical Advisory Committee;
authorised officers and their functions and powers.
Part 1.2 Interpretation
Division 1 Defined terms
A Scheduled substance is a substance to which a
Schedule to the medicines and poisons standard applies.
Note for subsection (1)
See section 16 for when the medicines and poisons standard applies to a substance.
A reference to a Scheduled substance by number is a reference to a substance to which the Schedule of that number of the medicines and poisons standard applies.
Example for subsection (2)
A reference to a Schedule 4 substance is a reference to a substance to which Schedule 4 of the medicines and poisons standard applies.
Note for section 7
Under the medicines and poisons standard, substances are classified according to the
Schedules in which they are included. The following is a general description of the substances:
(a) Schedule 2 substances may require advice from a pharmacist or retailer licensee to be used safely but are available without a prescription;
(b) Schedule 3 substances require advice from a pharmacist to be used safely but are available without a prescription;
(c) Schedule 4 substances are available from a pharmacy only on prescription and are commonly known as "prescription only medicines", including prescription animal remedies;
(d) Schedule 5 substances have a low potential for causing harm;
(e) Schedule 6 substances have a moderate potential for causing harm;
(f) Schedule 7 substances have a high potential for causing harm and are available only to the holder of an authority for non-human use;
(g) Schedule 8 substances are available only on prescription with restrictions to reduce abuse, misuse or dependence;
(h) Schedule 9 substances are generally illegal substances that are subject to abuse or misuse;
(i) Schedule 10 substances are substances, other than Schedule 9 substances, the supply and use of which are prohibited because of the degree of danger to health they represent.
An unrestricted Schedule 4 substance is a substance other than a restricted Schedule 4 substance.
A restricted Schedule 4 substance is a substance declared under section 246(1)(a) to be a restricted Schedule 4 substance.
A pesticide is a substance that is:
a Schedule 5, 6 or 7 substance; and
a pesticide as defined in the medicines and poisons standard.
An unrestricted Schedule 8 substance is a Schedule
8 substance other than a restricted Schedule 8 substance.
A restricted Schedule 8 substance is a Schedule 8 substance declared under section 246(1)(b) to be a restricted
Schedule 8 substance.
A prohibited substance is any of the following substances:
a Schedule 9 substance;
a Schedule 10 substance.
Subdivision 2 Medicines and poisons standard
(1) The medicines and poisons standard is the poisons standard as in force from time to time as modified under this section.
(2) A regulation may declare a substance is taken to be included in, or excluded from, a provision of the medicines and poisons standard.
(3) The declaration may impose restrictions in relation to dealings with the substance.
(4) For subsection (1), but subject to a modification under this section:
(a) an amendment of a current poisons standard takes effect on the date of effect of the instrument of amendment under the Legislative Instruments Act 2003 (Cth); and
(b) a new poisons standard takes effect on the date of effect of the standard under the Legislative Instruments Act 2003 (Cth).
In this section:
current poisons standard means the current Poisons Standard as defined in section 52A of the Therapeutic Goods Act.
new poisons standard means a document prepared under section 52D(2)(b) of the Therapeutic Goods Act.
poisons standard means the document prepared under section 52D(2) of the Therapeutic Goods Act.
(1) A term defined in the medicines and poisons standard has the same meaning in this Act.
(2) A provision of the medicines and poisons standard relating to the interpretation of the standard applies in the interpretation of this Act.
Examples for subsection (2)
1 Subject to stated exceptions, a reference in the medicines and poisons standard to a substance in a Schedule or Appendix to the standard includes:
(a) a substance prepared from natural sources or artificially; and
(b) every salt, active principle or derivative of the substance; and
(c) a preparation or admixture containing any proportion of the substance.
2 Accordingly, subject to the exceptions, a reference to the substance in this Act includes a reference to those things.
3 In addition, unless there is a contrary intention, the standard does not apply to the following:
(a) a substance in stated preparations or products;
stated substances;
(c) some low concentrations of stated substances;
(d) some impurities in pesticides.
Note for section 15
Under section 30, this Act prevails if there is an inconsistency between this Act and the medicines and poisons standard.
For this Act, a Schedule or Appendix to the medicines and poisons standard applies to a substance in a circumstance if:
the substance is included in the Schedule or Appendix; and
either:
(i) the standard does not, in the circumstance, exclude the substance from the operation of the Schedule or Appendix; or
(ii) a restriction in the standard applies in relation to the substance in the circumstance.
Example for paragraph (b)(ii)
If a Schedule 2 substance is listed as restricted "for human therapeutic use" and the substance is included only in that schedule, the standard applies to the substance only for human therapeutic use.
Subdivision 3 Dealing with Scheduled substances
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