TGA consults on PI, CMI
May 14, 2013
THE Therapeutic Goods
Administration has launched a
public consultation on possible
new mechanisms to “maintain
the currency of approved Product
Information (PI) and Consumer
Medicine Information (CMI)”.
The major move is one of
the outcomes of the 2010 TGA
Transparency Review, which found
that the TGA needs to explore a
mechanism of maintaining the
currency of the information,
“including consideration of links to
other information providers”.
The consultation document raises
a number of issues, including the
potential publication of PI and CMI
for all over-the-counter medicines,
including S2 and S3 items, as well
as considering a requirement that
CMI be available to the public for
all registered medicines.
There’s also consideration of
proposed changes to the ordering
of information on the PI document,
to place clinically relevant
information about indications,
contraindications, warnings
and precautions earlier in the
document.
“The current PI does not highlight
this information and therefore
the TGA is considering whether
re-formatting of the PI would assist
healthcare professionals with
appropriate prescribing,” according
to the consultation document.
The TGA has also raised concerns
that PI and CMI are not kept upto-
date once the initial approval
process has occurred and the
medicine has been registered.
This could be addressed by a
range of mechanisms including
providing an archive of previous
versions in the public search facility,
as well as establishing linkages
between the ARTG, PI/CMI and
AusPAR search facilities.
The consultation document is
now online at the TGA website, and
interested parties are invited to
provide feedback by 13 June.
Workshops will also take place
this month to consult with peak
bodies representing consumers,
health professionals and suppliers,
as well as providers of therapeutic
goods information.
More info at tga.gov.au.
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