Strong regulation in Aus
February 16, 2016
Australian medicines are
highly regulated by the Therapeutic
Goods Administration (TGA)
making them the safest option for
consumers to choose when seeking
complementary medicines, says the
Australian Self-Medication Industry
(ASMI).
Director of regulatory and
scientific affairs Steve Scarff said,
“Australia’s system of regulating
complementary medicines is one of
the most rigorous in the world.
“In Australia, there are strict
controls over manufacturing
standards for complementary
medicines to assure the safety and
quality of the medicines.”
Scarff also pointed out that
there are strict controls over the
ingredients in complementary
medicines and only those
ingredients already approved by
the TGA can be used.
“Labelling of complementary
medicines is highly regulated to
ensure labels contain the right
information to help consumers
select and use these products
appropriately.
“Complementary medicines, like
all medicines, can only be legally
supplied in Australia when the
TGA’s unique identifying number
has been included on the label.
“This unique number is preceded
by an AUST L or AUST R, depending
on its regulatory classification.”
Companies supplying products
with a label number must hold
evidence for the claims they make,
which means the numbers act as a
safeguard, Scarff clarified.
“Any adverse reaction should
be immediately reported to a
healthcare professional. The TGA
has processes in place to analyse
and respond to adverse event
reports and ASMI strongly supports
them,” he added.
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