TGA proposes PI changes
June 25, 2010
THE Therapeutic Goods
Administration is seeking feedback
on a new approach to Product
Information, which will see a single
PI document approved and
published for each prescription
medicine product.
The move is hoped to cut down
on confusion arising from the
current availability of “published”
product information and
“registered” product information.
The current policy stipulates that
“a sponsor must have a PI for all
registered medicines, however, not
all registered presentations may be
marketed.
“A sponsor may choose to have
and maintain two PI documents,
one for all registered product
presentations or non-marketed
product presentations and another
for marketed product
presentations.”
This ruling means that sponsors
may include on the ARTG website
a pack size or container not
currently available in Australia,
meaning that the “Registered” PI
may include a pack or size not
available in the country not
covered in a “Published” PI.
This product information
discrepancy, according to the TGA
has left the door open to product
confusion - not only in the minds of
the public but in the healthcare
sector itself.
The proposed policy intends to
ensure the registered PI and
published PI are one in the same
document, thus abolishing the
clause that allows the publication of
information relating to documents
where pack/container sizes are not
marketed in Australia.
If this option is not palatable the
TGA has also suggested that the PI
may be made to include a standard
statement saying “not all strengths/
dose forms/pack/container sizes
(delete as appropriate) are being
distributed in Australia”.
Stakeholders are advised to
outline any concerns about the
proposed approach by 26 Jul.
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