ANZTPA edges ever closer
January 9, 2013
UNDER a joint scheme for
regulation of therapeutic products
to be administered by the Australia
New Zealand Therapeutic Products
Agency (ANZTPA), a medicine will
be defined in a way that will
include the following product
types: prescription, OTC and
complementary medicines; most
medical gases; vaccines; allergens;
biotechnology medicines; plasma
products, including immunoglobulins;
radiopharmaceuticals; most
radio-contrast agents; dialysis
solutions (except haemodialysis
solutions); and sunscreens.
The definition is part of a
discussion paper published by
ANZRPA, which is described as a
“conversation starter” outlining the
contents of a possible regulatory
scheme for therapeutic products in
Australia and NZ.
Interestingly, the paper discusses
New Zealand’s plans to operate
separate regulation for certain lowrisk
‘natural health and
supplementary products which
would be reviewed five years after
its commencement to consider
whether or not to maintain a
separate scheme.
In terms of standards, the
discussion paper states that
ANZTPA will be able to determine
standards for medicines to be set
out in Orders and relating to: the
quality of medicines and ingredients
in medicines; the manufacture of
medicines; containers, closures and
packaging; presentation of
medicines; information for
consumers and healthcare
professionals, including product
labels; terminology to be used in
applications and in information for
consumers or healthcare
professionals; and other matters
concerning the quality, safety and
efficacy of medicines.
In addition, the paper states that a
medicine covered by the joint
scheme will only be able to be:
imported into Australia or NZ;
exported to a third country from
Australia or NZ; and supplied in
Australia or NZ by the holder of a
product approval granted by ANZTPA,
unless specifically exempted.
Meanwhile, medicines intended
for supply in Australia and/or NZ
will be classified as either Class 1
medicines or Class 2 medicines.
The classification will determine
the product approval procedure
that applies to the medicine.
The classification of a medicine
will be based on a number of
factors, including: the intrinsic risk
of the product; the risks associated
with the quality of the product; and
the risks associated with the
intended use(s) of the product.
Class 1 medicines will be low risk
and the product approval procedure
will be based on certifications made
by the applicant and an automated
validation of key data by ANZTPA.
Class 2 medicines will be higher
risk and the product approval
procedure will be based on a premarket
evaluation of the quality,
safety and efficacy of the medicine
undertaken by ANZTPA.
To view the document visit
www.anztpa.org.
The document is open for
consultation until 21 February.
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