ColoSTAT® application for an Australian Register of Therapeutic Goods and TGA 26 page response

The request was partially successful.

Ragnar Lothbrok

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

TGA FOI, Therapeutic Goods Administration

4 Attachments

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


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]




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Ragnar Lothbrok


Withdraw request as per your advice, Thank you

Yours sincerely,

Ragnar Lothbrok