LABELLING
REQUIREMENTS FOR IMPORTED MEDICINES
This fact sheet has been written in consultation
with Medicines Australia and with the purpose of
clarifying the labelling requirements for imported
medicines as prescribed by the Commerce (Trade
Descriptions) Act 1905 (the Act) and the Commerce
(Imports) Regulations 1940 (the Regulations).
The Act and Regulations set
out the labelling requirements for goods imported
into Australia. Customs administers this
legislation.
Imported medicines fall within
the class of goods described in regulation 7(1)(b)
of the Regulations. They therefore require a trade
description with the name of the country in which
the goods were made or produced and a true
description of the goods.
The trade description must be
in the form of a principal label or brand affixed in
a prominent position and in as permanent a manner as
practicable to the goods, for example, on the
package that the items are customarily exposed or
offered for sale. It is not necessary to mark both
the packaging and the medicines.
While the term "true
description" is not defined in the Commerce (Trade
Descriptions) Act or the Commerce (Imports)
Regulations, what is a true description will vary
according to the goods. A general guide is to
provide a factual description of the medicines in
question, and could include brand names or
scientific names, the constituent chemicals, or the
method of investigation.
Additionally, Regulation 8
specifies that the trade description must be:
• in the English language;
• in prominent and legible characters;
• on a principal label or brand affixed in a
prominent position and in as permanent a manner as
practicable to the goods; and
• if affixture to the goods is impracticable, to the
covering containing the goods.
Any other information included
on the label, brand or packaging must not contradict
or obscure the required trade description. This
includes illustrations, wording or size of
lettering.
In addition, the Act prohibits
the importation of goods that bear a false trade
description. A false trade description can be any
description of goods that is false or misleading.
Country of Origin under the
Trade Practices Act 1974 Establishing what is meant
by the country or place of origin of goods is
sometimes difficult. Section 65AE was added to the
Trade Practices Act 1974 (the TPA) in 1998 to
overcome this uncertainty concerning goods produced
for the Australian market, and goods produced
overseas and sold in Australia.
The scheme consists of a
two-step test:
The primary test in section 65AE is a qualitative
measure which considers that:
(1) …goods are substantially
transformedin a country if they undergo a
fundamental change in form, appearance or nature
such that the goods existing after the change are
new and different goods from those existing before
the change.
The secondary test is a
quantitative measure which refers to the costs of
production or manufacture incurred in Australia and
other countries.
For example, goods which claim
to be 'Made in Australia', must have incurred 50 per
cent or more of their total manufacturing costs in
Australia.
Goods which claim to be a
'Product of Australia' or 'Produced in Australia'
must have 'all or virtually all' Australian
ingredients or inputs, and 'all or virtually all' of
the steps in the production process must have
occurred in Australia.
The costs of production are
measured by a system based on the practice of the
Australian Customs Service that includes the cost of
labour and materials, overheads, and research and
development.