Medicines, Poisons and Therapeutic Goods Act 2008

This Act is the Medicines, Poisons and Therapeutic Goods Act 2008.

The dictionary at the end of this Act is part of this Act.

Note 1 The dictionary at the end of this Act defines certain terms used in this Act, and includes references (signpost definitions) to other terms defined elsewhere in this Act.

For example, the signpost definition ‘authorisation holder, for part 8.1 (Authorisations—disciplinary action)—see section 139.’ means that the term ‘authorisation holder’ is defined in that section for part 8.1.

Note 2 A definition in the dictionary (including a signpost definition) applies to the entire Act unless the definition, or another provision of the Act, provides otherwise or the contrary intention otherwise appears (see Legislation Act, s 155 and s 156 (1)).

A note included in this Act is explanatory and is not part of this Act.

Note See the Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.

Other legislation applies in relation to offences against this Act.

Note 1 Criminal Code

The Criminal Code, ch 2 applies to all offences against this Act (see Code, pt 2.1).

The chapter sets out the general principles of criminal responsibility (including burdens of proof and general defences), and defines terms used for offences to which the Code applies (eg conduct, intention, recklessness and strict liability).

Note 2 Penalty units

The Legislation Act, s 133 deals with the meaning of offence penalties that are expressed in penalty units.

Chapter 2 Operation of Act

The main object of this Act is to promote and protect public health and safety by minimising—

accidental and deliberate poisonings by regulated substances; and

medicinal misadventures related to regulated substances; and

the diversion of regulated substances for abuse; and

the manufacture of regulated substances that are subject to abuse; and

harm from regulated therapeutic goods.

The objects of this Act also include ensuring that—

consumers of prescription medicines have adequate information and the understanding necessary to allow them to use the medicines safely and effectively; and

consumers of non-prescription medicines have adequate information and the understanding to allow them to select the most appropriate medicines for their condition and to use the medicines safely and effectively, taking into account the condition of their health.

In regulating the dealings of health practitioners or veterinary practitioners with regulated substances, the chief health officer may, but need not, choose to take disciplinary action rather than pursuing prosecutions under this Act if the chief health officer believes it would be in the public interest to do so.

In this section:

non-prescription medicine means a medicine other than a prescription medicine.

prescription medicine means a prescription only medicine or controlled medicine.

A health practitioner or a veterinary practitioner who prescribes or supplies a medicine must ensure that the prescription or supply of the medicine is for a quantity and purpose that is consistent with the recognised therapeutic standard of what is appropriate in the circumstances.

Subsection (1) does not apply to wholesale supply.

The obligations under this Act are additional to the obligations under any other territory law unless this Act, or the other law, provides otherwise.

Example

If there is an obligation under the Dangerous Substances Act 2004 and under this Act in relation to a particular substance, both obligations must be complied with in relation to the substance unless either Act provides otherwise.

This Act prevails if there is an inconsistency between this Act and the medicines and poisons standard.

Note A reference to an Act includes a reference to the statutory instruments made or in force under the Act, including any regulation (see Legislation Act, s 104).

The defined provisions of this Act do not apply to an adult to the extent that the substance is an amount of cannabis that the adult is not prohibited from cultivating or possessing under the Drugs of Dependence Act 1989.

In this section:

defined provisions of this Act means the following:

section 26 (2) (Supplying declared substances);

section 33 (Manufacturing regulated substances);

section 35 (1) (Obtaining certain declared substances);

section 36 (Possessing certain declared substances);

section 37 (2) (Administering certain declared substances).

Chapter 3 Important concepts

Part 3.1 Substances to which Act applies

In this Act:

regulated substance means a medicine, poison, prohibited substance or schedule 10 substance.

In this Act:

medicine means—

a pharmacy medicine; or

a pharmacist only medicine; or

a prescription only medicine; or

a controlled medicine.

In this Act:

controlled medicine means a substance to which the medicines and poisons standard, schedule 8 applies.

Note Schedule 8 medicines are prescription medicines that have additional restrictions to reduce misuse or dependence. The schedule includes some derivatives of the scheduled medicines (see s 16 (2)).

pharmacist only medicine means a substance to which the medicines and poisons standard, schedule 3 applies.

Note Schedule 3 medicines are medicines that require advice from a pharmacist to be used safely. The schedule includes some derivatives of the scheduled medicines (see s 16 (2)).

pharmacy medicine means a substance to which the medicines and poisons standard, schedule 2 applies.

Note Schedule 2 medicines are medicines that may require advice from a pharmacist to be used safely. The schedule includes some derivatives of the scheduled medicines (see s 16 (2)).

prescription only medicine means a substance to which the medicines and poisons standard, schedule 4 applies.

Note Schedule 4 medicines are medicines (including prescription animal remedies) that are available from a pharmacy on prescription. The schedule includes some derivatives of the scheduled medicines (see s 16 (2)).

In this Act:

poison means—

a low harm poison; or

a moderate harm poison; or

a dangerous poison.

In this Act:

dangerous poison means a substance to which the medicines and poisons standard, schedule 7 applies.

Note Schedule 7 applies to substances with a high potential for causing harm. The schedule includes some derivatives of the scheduled substances (see s 16 (2)).

low harm poison means a substance to which the medicines and poisons standard, schedule 5 applies.

Note Schedule 5 applies to substances with a low potential for causing harm. The schedule includes some derivatives of the scheduled substances (see s 16 (2)).

moderate harm poison means a substance to which the medicines and poisons standard, schedule 6 applies.

Note Schedule 6 applies to substances with a moderate potential for causing harm. The schedule includes some derivatives of the scheduled substances (see s 16 (2)).