Commonwealth Numbered Regulations

1990 No. 394 THERAPEUTIC GOODS REGULATIONS - SCHEDULE 5

SCHEDULE 5
Regulation 12
THERAPEUTIC GOODS EXEMPT FROM THE OPERATION OF
PART 3 OF THE ACT Column 1 Column 2 Item No. Therapeutic goods
 1        therapeutic goods that are imported for use in the

treatment of the importer or the importer's immediate
family where:

   (a)  the goods do not contain a substance the
importation of which is prohibited under the Customs 
Act 1901 ; and

   (b)  in the case of injections - the goods are
the subject of an approval under section 19 of the
Act; and

   (c)  in the case of other drugs - the quantity
imported represents not more than 3 month's supply at
the maximum dose recommended by the manufacturer; and

   (d)  if the goods are subject to Schedule 4 to
the Poisons Standard - the goods are the subject of a
written authority issued by a medical practitioner
registered under a law of a State or Territory, except
where the goods are carried by the importer as a
passenger on a ship or aeroplane
 2        therapeutic goods that are exported and that:


   (a)  are not for commercial supply; and

   (b)  do not contain a substance the exportation of
which is prohibited under the Customs Act 1901
 3        samples of therapeutic goods supplied for:


   (a)  submission to a regulatory authority; or

   (b)  subjection to developmental or quality
control procedures; or

   (c)  examination, demonstration or display; or

   (d)  subjection to analysis or laboratory testing
procedures;
but not for supply for therapeutic use in humans
 4        goods imported solely for the purpose of export

that remain subject to the control of the Customs and
that are not subject to manufacture in Australia
 5        goods imported into Australia that are held under

the direct control of the sponsor pending approval for
registration or listing
 6        therapeutic goods that are produced or dispensed

or extemporaneously compounded for a particular person
for therapeutic application to that person (other than
therapeutic devices referred to in item 3 of Schedule
3, or electronic devices that must be programmed for
each patient using them)
 7        the following therapeutic devices and parts of

therapeutic devices:

   (a)  components and parts of therapeutic devices
intended for use in the manufacture, installation,
repair or maintenance of devices that are not provided
separately to the consumer as an accessory or
consumable component;

   (b)  diagnostic goods for in vitro use other
than:

        (i)    goods for home use; or

        (ii)   goods that incorporate material of human
origin; or

        (iii)  goods supplied as a pharmaceutical
benefit; or

        (iv)   goods for use in the diagnosis of
infection with Human Immunodeficiency Virus; or

        (v)    antimicrobic susceptibility discs

   (c)  non implantable, non powered diagnostic
tools and instruments that are not supplied in a
sterile state and that are not referred to in
paragraph (b);

   (d)  non-powered surgical or dental instruments
that depend on manual dexterity for their use and are
not supplied in a sterile state, other than flexible
tubes, catheters, cannulae, fluid and gas lines and
other instruments that introduce fluids or gases to,
or remove them from, the body;

   (e)  manufacturing, laboratory and dispensary
equipment used in the preparation of therapeutic goods
other than equipment specifically designed to process
a patient's blood or other tissues for reintroduction
to that patient;

   (f)  therapeutic devices for dental use (other
than devices of human or animal origin and devices
that, when used, are implanted directly into bone or
soft tissue) that are:

        (i)    constructed externally to the mouth and
fitted or fixed into the mouth on a temporary or
permanent basis and intended to correct an
irregularity or deficiency; or

        (ii)   dental impression materials;
including devices worn to protect teeth from
external trauma;

   (g)  non-powered equipment used in general
patient care being equipment that does not constitute
or contribute to a specific diagnosis, monitoring or
treatment of a medical condition;

   (h)  furniture other than powered appliances for
use in diagnosis or treatment of a medical condition;

        (i)    linen and bedding other than linen and
bedding supplied in a sterile state;

   (j)  protective clothing for patients or health
workers other than:
               (i)   clothing supplied in a sterile state; or


        (ii)   surgeon's gloves and patient examination
gloves; or

        (iii)  patient nuclear radiation shielding
apparel;

   (k)  communications equipment;

   (l)  containers other than syringes

   (m)  therapeutic devices:

        (i)    imported by their users before the
commencement of the Act; and

        (ii)   that are still in use for administration
to, or application in the treatment of, patients
 8             the following drugs unless the indications

proposed by the sponsor are in the treatment of a
condition referred to in clause 4 of the Therapeutic
Goods Advertising Code:

   (a)  homoeopathic preparations more dilute than a
one thousand fold dilution of a mother tincture and
which are not required to be sterile;

   (b)  antiperspirant preparations that derive
their antiperspirant properties from inorganic salts
of aluminium, zinc or zirconium only;

   (c)  unmedicated anti-acne preparations having
only a cleansing action or purpose;

   (d)  medicated insect repellants for dermal use
except those that are included in a Schedule to the
Poisons Standard;

   (e)  lotions, shampoos or hairdressings for the
prevention or treatment of dandruff except those that
are included in a Schedule to the Poisons Standard;

   (f)  disinfectants;

   (g)  sunscreen preparations for dermal use that
when tested as described in Australian Standard
AS2604-1986 as amended from time to time, are
established to have, and claim on their labels, a sun
protection factor below 4 or the equivalent category
description
 9        the following drugs:


   (a)  starting materials used in the manufacture
of therapeutic goods, except when:

        (i)    prepackaged for supply for other
therapeutic purposes; or

        (ii)   formulated as a dosage form;

   (b)  blood and blood components manufactured by
the Australian Red Cross Society
 10       Japanese encephalitis vaccine:


   (a)  that is imported by the undertaking known as
Commonwealth Serum Laboratories for supply to
Fairfield Hospital in the State of Victoria; and

   (b)  that is supplied to that Hospital for use in
patients who have given adequately informed consent to
the proposed treatment before it is commenced, being
patients who:
               (i)   are to be resident for more than 12 months

in an area in which Japanese
encephalitis is endemic;
or

        (ii)   make, or are to make, repeated short trips
to areas in which Japanese
encephalitis is endemic; or

        (iii)  intend to visit rural areas in areas in
which there is an epidemic of
Japanese encephalitis;
and

   (c)  that is to be approved for administration to
each patient by, or at the direction of, the Director
of Medical Services at that Hospital; and

   (d)  that is prescribed by a medical practitioner
working at the hospital who is not the person who
approved its administration to the patient to whom it
is administered
 11            therapeutic goods:


   (a)  in relation to the importation of which a
licence or permission is in force:

        (i)    under regulation 5A, 5B or 5C of the Customs
(Prohibited Imports) Regulations; and

        (ii)   by the Secretary or, in the case of a
licence or permission granted under regulation 5A, 5B
or 5C of those Regulations, by an authorised person
within the meaning of that regulation; and

        (iii)  before the commencement of the Act; and

   (b)  which are supplied in Australia for use in
humans not more than 6 months after the commencement
of the Act