Dear Ragnar Lothbrok

 

I am writing to notify you that the Department of Health and Aged Care has
forwarded your request to the Therapeutic Goods Administration (TGA) for
access to documents under the Freedom of Information Act 1982 (FOI Act).

 

The TGA is currently processing an FOI request for documents relating to
the ColoSTAT application for entry on to the Australian Register of
Therapeutic Goods (ARTG). It is likely that the decision maker will
release these documents to the applicant subject to any exemption claims
made by the third parties whose documents fall within the scope of this
request.

 

Under section 11C of the FOI Act, the TGA has an obligation to publish
documents released under the FOI Act on its Disclosure Log, unless it
would be unreasonable to do so. Unless the affected third parties object
to this, these documents will subsequently be published on the TGA’s FOI
disclosure log once they have been released to the applicant. A decision
for this request is currently due 20 June 2023.

 

We invite you to consider withdrawing your request until these documents
are published on the TGA’s FOI disclosure log as they are likely to cover
your request as outlined below. If you choose not to withdraw, the TGA
will process your request as normal.

 

However, where there is a requirement to undertake consultation with
affected third parties, this timeframe is extended by a further 30 days.
It may also be extended in certain circumstances, including with your
agreement or where the Department applies to the Office of the Australian
Information Commissioner for an extension.

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.

 

We would be grateful if you could advise if you wish to withdraw your
request by COB Wednesday 24 May 2023.

 

If you have any questions or concerns, please don’t hesitate to contact
the FOI team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

 

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Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.

 

 

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