Biologicals guideline
July 15, 2011
THE Australian Regulatory
Guidelines for Biologicals (ARGB) is
now available for viewing on the
TGA website.
The guide explains which
products are included in the new
Biologicals Regulatory Framework,
and why; and describes transition
arrangements that apply for up to
three years to allow all biologicals
to meet the new arrangements.
The guide also explains the
Australian regulatory requirements
for supplying biological, and sets
out what is required for making an
application to the TGA for
biologicals, so they can be
processed as quickly as possible.
Sponsors, manufacturers, health
professionals, regulators and
consumers, are also able to openly
access information on biologicals,
and the Therapeutic Goods Act.
See www.tga.gov.au.
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