Package of reforms years in the making strengthens consumer protections
19 February 2018
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The Australian Self Medication Industry (ASMI)
has commended the passage of The Therapeutic Goods Bill (2017
Measure No.1), which enable a package of several important reforms
that will strengthen protection for consumers.
These reforms include:
- the expansion of the permitted indications (claims for and
purpose of medicine) to be used with listed medicines
- the establishment of an additional pathway for
- stronger compliance and enforcement powers for the TGA;
- an amendment that extends the current arrangements for the
pre-approval therapeutic goods advertisements until 30 June 2020.
This replaces the original draft, in which the pre-approval system
was to be replaced with a self-regulatory system.
Currently, product sponsors can access a
pre-approval scheme that picks up errors and potential breaches of
the Therapeutic Goods Advertising Code (TGAC) specifically and
Therapeutic Goods legislation generally.
This system will continue to protect consumers
from exposure to potentially false and misleading advertisements.
It will also help medicines advertisers, publishers and
broadcasters to ensure that advertisements comply with the
Therapeutic Goods legislation.
The Bill will also provide the TGA with stronger
compliance and enforcement powers, including graduated penalties
for non-compliant behavior.
The postponement of the abolition of the pre-approval system
will allow for the impact of new self-regulatory measures to be
assessed after 18 months.
ASMI has already been working with our members and a range of
stakeholders to develop a self-regulatory replacement system and we
will continue to do so to ensure the success of the move to a
ASMI also supports the expansion of the permitted indications
"This will clean up the free text mechanism, which is where
medicine sponsors make up their own indications," says ASMI CEO,
"Now, if sponsors want to market products with stronger
indications, they will have the option of using the new pathway for
intermediate risk medicines."
"This is a huge improvement that provides industry with greater