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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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.

 

 

-----Original Message-----
From: Ragnar Lothbrok <[6][FOI #10328 email]>
Sent: Friday, 19 May 2023 10:09 AM
To: FOI <[7][email address]>
Subject: Freedom of Information request - ColoSTAT® application for an
Australian Register of Therapeutic Goods and TGA 26 page response

 

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Dear Therapeutic Goods Administration,

 

I would like to obtain a copy of the 26 page response from the Therapeutic
Goods Association with regard to an application made by an ASX listed
company called Rhythm Biosciences Ltd (ASX code RHY) and/or Vision Tech
Bio Pty Ltd for a product called COLOSTAT to be entered on the ARTG..  The
lodgement date of the application was on or around 12 May 2022.  The
response from the TGA and subsequent withdrawal of application by Rhythm
Biosciences Ltd and/or Vision Tech Bio Pty Ltd was on or around 6 March
2023.

I am an investor in Rhythm Biosciences Ltd and the company has not
disclosed why it withdrew its application in detail.  Obtaining this 26
page report will allow me to re-evaluate my investment.

 

Yours faithfully,

Ragnar Lothbrok

 

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[8][FOI #10328 email]

 

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using this form:

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This request has been made by an individual using Right to Know. This
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More information on how Right to Know works can be found at:

[11]https://www.righttoknow.org.au/help/offi...

 

Please note that in some cases publication of requests and responses will
be delayed.

 

If you find this service useful as an FOI officer, please ask your web
manager to link to us from your organisation's FOI page.

 

 

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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."

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