Commonwealth Numbered Acts

THERAPEUTIC GOODS ACT 1989 No. 21 of 1990 - SECT 3

3. (1) In this Act, unless the contrary intention appears:

"advertisement", in relation to therapeutic goods, includes any statement,
pictorial representation or design, however made, that is intended, whether
directly or indirectly, to promote the use or supply of the goods;

"authorised person", in relation to a provision of this Act, means:

   (a)  an officer of the Department, of another Department or of an authority
        of the Commonwealth; or

   (b)  an officer of:

   (i)  a Department of State of a State; or

   (ii) a Department or administrative unit of the Public Service of a
        Territory; or

   (iii) an authority of a State or of a Territory; being a Department, unit
        or authority that has functions relating to health matters; or

   (c)  a member of the Australian Federal Police; who is authorised in
        writing by the Secretary to exercise powers under that provision;

"batch" means a quantity of a product that is:

   (a)  uniform in composition, method of manufacture and probability of
        chemical or microbial contamination; and

   (b)  made in one cycle of manufacture and, in the case of a product that is
        sterilised or freeze dried, sterilised or freeze dried in one cycle;

"bioburden", in relation to therapeutic goods, means the quantity and
characteristics of microorganisms present in the goods or to which the goods
may be exposed in a manufacturing environment;

"British Pharmacopoeia" means the edition of the book of that name, including
any additions or amendments, that was in effect for the purposes of the
Therapeutic Goods Act 1966 immediately before the commencement of this section
and, if additions or amendments of that book are made after that commencement,
or new editions of that book are published after that commencement, includes
those additions or amendments, or those new editions, from a day specified by
the Minister by order published in the Gazette;

"British Pharmacopoeia (Veterinary)" means the latest edition of the book of
that name, including any additions or amendments, published on the
recommendation of the Medicines Commission of the United Kingdom immediately
before the commencement of this section and, if additions or amendments of
that book are made after that commencement, or new editions of that book are
published after that commencement, includes those additions or amendments, or
those new editions, from a day specified by the Minister by order published in
the Gazette;

"container", in relation to therapeutic goods, means the vessel, bottle, tube,
ampoule, syringe, vial, sachet, strip pack, blister pack, wrapper, cover or
other similar article that immediately covers the goods, but does not include
an article intended for ingestion;

"corporation" means a body corporate that is:

   (a)  a foreign corporation; or

   (b)  a trading corporation formed within the limits of the Commonwealth or
        a financial corporation so formed;

"directions for use", in relation to therapeutic goods, includes information
on:

   (a)  appropriate doses of the goods; and

   (b)  the method of administration or use of the goods; and

   (c)  the frequency and duration of treatment for each indication of the
        goods; and

   (d)  the use of the goods by persons of particular ages or by persons
        having particular medical conditions;

"exempt goods", in relation to a provision of Part 3 or 4, means therapeutic
goods that are exempted from the operation of that Part by the regulations;

"exempt person", in relation to therapeutic goods, means a person exempted
from the operation of Part 4 in relation to those goods by the regulations;

"financial corporation" means a financial corporation within the meaning of
paragraph 51 (xx) of the Constitution;

"foreign corporation" means a foreign corporation within the meaning of
paragraph 51 (xx) of the Constitution;

"indications", in relation to therapeutic goods, means the specific
therapeutic uses of the goods;

"label", in relation to therapeutic goods, means a display of printed
information:

   (a)  on or attached to the goods; or

   (b)  on or attached to a container or primary pack in which the goods are
        supplied; or

   (c)  supplied with such a container or pack;

"licence" means a licence under Part 4;

"listable devices" means therapeutic devices that are required to be included
in the part of the Register for listed goods;

"listed goods" means therapeutic goods that are included in the part of the
Register for goods known as listed goods;

"listing number", in relation to listed goods, means any combination of
numbers, symbols and letters assigned to the goods under section 27;

"manufacture", in relation to therapeutic goods, means:

   (a)  to produce the goods; or

   (b)  to engage in any part of the process of producing the goods or of
        bringing the goods to their final state, including engaging in the
        processing, assembling, packaging, labelling, storage, sterilising,
        testing or releasing for sale of the goods or of any component or
        ingredient of the goods as part of that process;

"manufacturing premises" means a building, a part of a building or a group of
buildings on one or more sites:

   (a)  that is for use in the manufacture of a particular kind of therapeutic
        goods; and

   (b)  at which the same persons have control of the management of the
        production of the goods and the procedures for quality control;

"manufacturing principles" means the principles for the time being having
effect under section 36;

"premises" includes:

   (a)  a structure, building, aircraft, vehicle or vessel; and

   (b)  a place (whether enclosed or built upon or not); and

   (c)  a part of a thing referred to in paragraph (a) or (b);

"presentation", in relation to therapeutic goods, means the way in which the
goods are presented for supply, and includes matters relating to the name of
the goods, the labelling and packaging of the goods and any advertising or
other informational material associated with the goods;

"primary pack", in relation to therapeutic goods, means the complete pack in
which the goods, or the goods and their container, are to be supplied to
consumers;

"quality", in relation to therapeutic goods, includes the composition,
strength, potency, stability, sterility, purity, bioburden, design,
construction and performance characteristics of the goods;

"Register" means the Australian Register of Therapeutic Goods maintained under
section 17;

"registered goods" means therapeutic goods included in the part of the
Register for goods known as registered goods;

"registration number", in relation to registered goods, means any combination
of numbers, symbols and letters assigned to the goods under section 27;

"Secretary" means the Secretary to the Department;

"sponsor", in relation to therapeutic goods, means a person who:

   (a)  exports, or arranges the export of, the goods from Australia; or

   (b)  imports, or arranges the importation of, the goods into Australia; or

   (c)  in Australia, manufactures the goods, or arranges for another person
        to manufacture the goods, for supply (whether in Australia or
        elsewhere);
but does not include a person who exports, imports or manufactures goods on
behalf of another person;

"standard", in relation to therapeutic goods, means a standard that:

   (a)  is specified in an order under section 10 that is applicable to the
        goods; or

   (b)  if no such order is applicable to the goods but the goods are the
        subject of a monograph in:

   (i)  in the case of goods for use in humans - the British Pharmacopoeia; or

   (ii) in the case of goods for use in animals - the British Pharmacopoeia
        (Veterinary); is constituted by the statements in that monograph;

"supply" includes:

   (a)  supply by way of sale, exchange, gift, lease, loan, hire or
        hire-purchase; and

   (b)  supply, whether free of charge or otherwise, by way of sample or
        advertisement; and

   (c)  supply, whether free of charge or otherwise, in the course of testing
        the safety or efficacy of therapeutic goods in persons or animals; and

   (d)  supply by way of administration to, or application in the treatment
        of, a person or animal;

"therapeutic devices" means therapeutic goods other than goods that are
represented to achieve, or are likely to be taken to achieve, any of the
principal purposes of their use as a result of chemical action within or upon
the body of a person or animal, but does not include therapeutic goods
declared by the Secretary, by order published in the Gazette, not to be
therapeutic devices;

"therapeutic goods" means goods:

   (a)  that are represented in any way to be, or that are, whether because of
        the way in which the goods are presented or for any other reason,
        likely to be taken to be:

   (i)  for therapeutic use; or

   (ii) for use as an ingredient or component in the manufacture of
        therapeutic goods; or

   (iii) for use as a container or part of a container for goods of the kind
        referred to in subparagraph (i) or (ii); or

   (b)  included in a class of goods the sole or principal use of which is, or
        ordinarily is, a therapeutic use or a use of a kind referred to in
        subparagraph (a) (ii) or (iii);
and includes goods declared to be therapeutic goods under an order in force
under section 7, but does not include:

   (c)  goods declared not to be therapeutic goods under an order in force
        under section 7; or

   (d)  goods in respect of which such an order is in force, being an order
        that declares the goods not to be therapeutic goods when used or
        labelled in the way specified in the order where the goods are used or
        labelled in that way; or

   (e)  foods;

"therapeutic use" means use in or in connection with:

   (a)  preventing, diagnosing, curing or alleviating a disease, ailment,
        defect or injury in persons or animals; or

   (b)  influencing, inhibiting or modifying a physiological process in
        persons or animals; or

   (c)  testing the susceptibility of persons or animals to a disease or
        ailment; and includes use in, or in connection with, contraception or
        testing for pregnancy;

"trading corporation" means a trading corporation within the meaning of
paragraph 51 (xx) of the Constitution.

(2) For the purposes of this Act:

   (a)  therapeutic goods are to be taken to be for use in animals if:

   (i)  the goods bear a name or description that indicates, or is likely to
        give the impression, that the goods are intended for use in animals
        and are not intended for use in humans; or

   (ii) the goods are otherwise represented, or otherwise purport, to be
        intended for use in animals and not intended for use in humans; and

   (b)  therapeutic goods are to be taken to be for use in humans if they are
        not solely for use in animals.

(3) The Secretary must, at least once in each year, cause to be published in
the Gazette a list of the names of all persons who are, at the time of
publication, authorised persons.

(4) The provisions of this Act are in addition to, and not in substitution
for, the provisions of any other Act that relate to therapeutic goods.

(5) For the purposes of this Act, the presentation of therapeutic goods is
unacceptable if it is capable of being misleading or confusing as to the
content or proper use of the goods and, without limiting the previous words in
this subsection, the presentation of therapeutic goods is unacceptable:

   (a)  if it states or suggests that the goods have ingredients, components
        or characteristics that they do not have; or

   (b)  if a name applied to the goods is the same as the name applied to
        other therapeutic goods that are supplied in Australia where those
        other goods contain additional or different therapeutically active
        ingredients; or

   (c)  if the label of the goods does not declare the presence of a
        therapeutically active ingredient; or

   (d)  if a form of presentation of the goods may lead to unsafe use of the
        goods or suggests a purpose that is not in accordance with conditions
        applicable to the supply of the goods in Australia; or

   (e)  in prescribed cases.

(6) A reference in this Act to an annual registration charge, an annual
listing charge or an annual licensing charge is a reference to such a charge
imposed under the Therapeutic Goods (Charges) Act 1989.