TGA reviews label proposals
November 6, 2012
THE Therapeutic Goods
Administration has responded to
significant opposition to several
facets of its medicines labelling and
packaging review by committing to
further discussion with stakeholders
into possible alternatives.
During the consultation period,
the TGA received 110 submissions
from consumers, academics,
healthcare professionals and
industry responding to its
Medicines Labelling and Packaging
Review Consultation Paper.
According to the TGA, there was
strong support for changes
regarding active ingredient
prominence, standardised medicine
information presentation,
dispensing label space and the
creation of a committee to provide
advice to the TGA on labelling and
packaging issues.
Despite this, there were six
consistent issues with the proposed
changes which came to light during
the consultation, as identified in
multiple submissions, including: the
need to have some differences in
the labelling requirements for
different classes of medicine
(prescription, over-the-counter and
complementary); as well as the
need, in subsequent analysis, to
provide evidence that particular
changes will improve medicine
safety and the quality use of
medicines; and greater clarity on
which proposed options are to be
mandated versus encouraged.
The remaining three issues
included: assessment of the cost of
particular options, and ability of
industry to implement them;
harmonisation of labelling plans
with other jurisdictions where
possible, including with New
Zealand; and a commitment to
undertake independent consumer
testing of proposed options,
followed by education and
awareness programs once they are
implemented.
The TGA also noted “consistently
divergent views regarding the way
to achieve the objectives of the
recommendations between
industry and consumer groups on
some issues, such as prominence of
active ingredient names and use of
umbrella branding”.
As such the TGA proposed that
these also be the subject of further
discussion with stakeholders.
Moving forward, the TGA has said
that as a next step, it will focus on
labelling requirements for
registered prescription and
non-prescription medicines.
“Separation of labelling and
packaging reform for different
classes of medicines will ensure
that thorough consideration of the
revised requirements and their
impact can be undertaken,
particularly for products at the
interface of therapeutic and
consumer products, such as
sunscreens,” the TGA said.
As such, the initial
recommendations will be refined to
more specifically reflect the needs
of registered prescription and OTC
medicines, and options discussed in
a separate paper.
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