New variations process
September 24, 2012
THE Therapeutic Goods
Administration has released details
of new processes for “minor
variations to prescription
medicines,” after a review
identified the need for changes to
be consistent with regulatory
requirements.
Under the changes, prior TGA
approval is required for all minor
variations to prescription medicines
prior to their implementation, and
are classified as either Safety-
Related Requests (SRRs) or Self-
Assessable Requests (SARs).
Sponsors will be required to
complete and submit new forms for
each type of minor variation when
making a request or application,
and the existing 45 working day
processing timeframe will also be
applied.
All safety-related requests will be
processed as minor variations, and
a new fee category will be applied
for any requests requiring TGA
evaluation of data, so the actual
cost to sponsors won’t change.
The changes will commence
following a process of
communication and consultation
with sponsors, with a three month
implementation period.
See www.tga.gov.au.
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