New TGA processes
April 10, 2013
The Therapeutic Goods
Administration has announced
that the outcomes of the review
of business processes for
minor variations to the entry of
prescription medicines in the ARTG
will be implemented effective
Wednesday 22 May 2013.
From this date, relevant
information for sponsors will be
published on the TGA website,
including updated guidance
documents, which take into
account all comments received
during consultation on the draft
documents, with the move
following TGA Industry Working
Group Meetings held last year.
New forms will be introduced for
each type of minor variation, which
will take into account all comments
received during consultation on the
draft forms.
Prior TGA approval will be
required for all new minor
variations. The TGA has committed
to processing all new selfassessable
requests (SARs) and
Category 3 applications within 45
working days.
Additionally, new safety-related
requests requiring TGA evaluation
will be processed as minor
variations; and the relevant fee
category will be applied from this
time onwards.
The changes are intended to
enhance the robustness of the
regulatory framework as well as
increase the certainty for sponsors
in TGA processing times for selfassessable
variations.
The TGA says it will also improve
the transparency of its processes by
updating the relevant appendices
of the Australian Regulatory
Guidelines for Prescription
Medicines to provide clear
guidance on TGA requirements
for the different types of minor
variations to registered prescription
medicines and more information
about the decision-making process.
To ensure that the changes
are implemented with minimal
disruption, there will be a threemonth
transition period for preapproval
of all minor variations and
new statutory timeframes for SARs.
The transition period ends 22
August 2013.
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