TGA confirms label changes
August 18, 2016
THE Therapeutic Goods
Administration yesterday published
two formal guidance documents on
medicine labels (PD 10 Aug), along
with the release of Therapeutic
Goods Orders 91 and 92.
TGO 91 is titled Standard for
labels of prescription and related
medicines, while TGO 92 is for
the labels of non-prescription
medicines.
The guidance is to “help sponsors
and manufacturers of medicines
meet the Australian labelling
requirements described in the new
labelling Orders,” the
TGA said.
“There are different
risks and information
requirements
associated with
medicines prescribed
by a medical
practitioner (or used
in a clinical setting) to
those self-selected by
consumers...as a result
the labels for these
two types of medicines
need to reflect the different
contexts in which they’re used.”
A four year transition period
has been provided for the
implementation of TGO 91 and
92, which together will eventually
replace the existing TGO 69
General requirements for labels for
medicines.
The Australian Self-Medication
Industry welcomed the new orders,
which mark the conclusion of the
TGA’s review of medicines labelling
and packaging.
“We greatly appreciate the
TGA’s inclusive, collaborative and
transparent approach throughout
the lengthy consultation process,
which ensured we achieved the
right outcome,” said ASMI ceo
Deon Schoombie.
The review kicked off in
2012, with an initial proposal
containing what ASMI described
as “impractical reforms...which
would have significantly impaired
consumers’ ability to recognise and
select well-known non-prescription
medicines,” making no distinction
between the different ways that
non-prescription and prescription
medicine labels are
used by consumers.
“For nonprescription
medicines the label is
the most important
source of information
for the consumer...
it should provide
sufficient information
for consumers to
appropriately select
and safely use
medicines.”
Schoombie said ASMI was
confident the new labelling order
would meet the needs of both
consumers and the industry.
The major changes for nonprescription
medicines are an
increase in the prominence of
active ingredients on the front
of the pack and for registered
medicines, a standardised format
for critical information on the back.
The new requirements will not
change the overall appearance
of well-known non-prescription
medicine brands, Schoombie added.
See www.tga.gov.au.
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