Key Points: Critical legislative reform in relation to the regulation
of therapeutic goods are now a reality with recent measures passed
by the Federal Government.
The Therapeutic Goods Amendment (Medical Devices and Other
Measures) Bill 2008 was recently passed by both houses of
parliament and will affect the operation of the Therapeutic Goods
Act (Cth) 1989 (the TG Act) in a variety of ways.
The changes include:
the introduction of provisions exempting certain medical
devices from the operation of the TG Act so that such devices can
be made available for use in an emergency;
amendments to the test of whether a person will be a "fit
and proper person" to hold a manufacturing licence or a
medical device conformity assessment certificate;
adoption of the European Pharmacopoeia and United States
Pharmacopeia standards under the TG Act;
amending provisions relating to the release of information to
the public from the Therapeutic Goods Administration (the
clarifying the operation of advertising provisions to ensure
that restrictions apply to advertisements in all media; and
amending the penalty provisions in the TG Act to bring them in
line with current policy.
In addition, a further Act was recently assented to by the
Governor-General. The Therapeutic Goods Amendment (2009 Measures
No1) Act2009 (Measures Act) is intended to clarify
the current regulation of therapeutic goods in Australia. In
particular, the Measures Act introduces the following changes:
allowing medicines to be temporarily suspended from the
Australian Register of Therapeutic Goods (ARTG) to
allow for the resolution of safety concerns during the suspension
requiring, except in limited circumstances, separate
manufacturing licences for each site which manufactures therapeutic
improving the powers of authorised officers under the TG Act to
attend and inspect sites;
introducing a new regulatory framework incorporating
homoeopathic and anthroposophic medicines from July 2011; and
converting lists currently containing permitted and prohibited
ingredients into legislative instruments that must be complied
Finally, the Therapeutic Goods Amendment (2009 Measures No. 2)
Bill 2009 (Measures 2 Bill) was introduced into
Parliament in June 2009. The Measures 2 Bill has now been passed by
the House of Representatives and is currently under consideration
by the Senate. If passed, the Measures 2 Bill will:
enable the Secretary of the Department of Health and Ageing to
declare purposes for which particular medical devices cannot be
included on the ARTG;
amend the advertising provisions in the TG Act to create an
offence for a person who inappropriately advertises a therapeutic
introduce separate scheduling arrangements for medicines and
implement provisions enabling the Minister to specify advisory
statements which must be included on the labels of particular
medicines by legislative instrument.
These changes reflect the Australian Government's regulatory
reform agenda, aimed at improving therapeutic good regulation in
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