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

[3][IMG][4][IMG][5][IMG]

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.

-----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

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

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

-------------------------------------------------------------------

Please use this email address for all replies to this request:

[8][FOI #10328 email]

Is [9][TGA request email] the wrong address for Freedom of Information
requests to Therapeutic Goods Administration? If so, please contact us
using this form:

[10]https://www.righttoknow.org.au/change_re...

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
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.

-------------------------------------------------------------------

"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."

References

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hide quoted sections

Good morning Mr Lothbrok

I apologise for the delay in responding.

Upon completion of the FOI request mentioned in our earlier email (FOI
4371), a decision was made not to publish the documents relevant to that
request.

Therefore, if you wish to obtain copies of the documents released for that
request, it will be necessary for you to submit a new FOI request.  Should
you submit a new request, the FOI team will be able to process the request
expeditiously and without charges.

You can submit a new request by replying to this email advising as such.

I note the original scope of your request was as follows:

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.

If you have any questions please contact the FOI team.

Kind regards
Karen

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

[3][IMG][4][IMG][5][IMG]

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. 

------------------------------------------------------------------------

From: Ragnar Lothbrok <[FOI #10328 email]>
Sent: 18 August 2023 01:34
To: TGA FOI <[email address]>
Subject: Internal review of Freedom of Information request - ColoSTAT®
application for an Australian Register of Therapeutic Goods and TGA 26
page response

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.
Dear TGA FOI,

Under section 11C of the FOI Act, the TGA has an obligation to publish
documents released under the FOI Act on its Disclosure Log
Please advise why the THA has not complied with my request.

Yours sincerely,

Ragnar Lothbrok

-----Original Message-----

From: Ragnar Lothbrok [6][FOI #10328 email]
Sent: 23 May 2023 15:15
To: TGA FOI [7][email address]
Subject: Re: FOR RESPONSE - Freedom of Information request - ColoSTAT®
application for an Australian Register of Therapeutic Goods and TGA 26
page response [SEC=OFFICIAL]

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.
Dear TGA FOI,

Withdraw request as per your advice,  Thank you

Yours sincerely,

Ragnar Lothbrok

From: TGA FOI <[email address]>
Sent: 23 May 2023 09:24
To: '[FOI #10328 email]'
<[FOI #10328 email]>
Cc: TGA FOI <[email address]>
Subject: FOR RESPONSE - Freedom of Information request - ColoSTAT®
application for an Australian Register of Therapeutic Goods and TGA 26
page response [SEC=OFFICIAL]

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: [8][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [9]www.tga.gov.au

[10][IMG][11][IMG][12][IMG]

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.

-----Original Message-----
From: Ragnar Lothbrok <[13][FOI #10328 email]>
Sent: Friday, 19 May 2023 10:09 AM
To: FOI <[14][email address]>
Subject: Freedom of Information request - ColoSTAT® application for an
Australian Register of Therapeutic Goods and TGA 26 page response

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

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

-------------------------------------------------------------------

Please use this email address for all replies to this request:

[15][FOI #10328 email]

Is [16][TGA request email] the wrong address for Freedom of Information
requests to Therapeutic Goods Administration? If so, please contact us
using this form:

[17]https://www.righttoknow.org.au/change_re...

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[18]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.

"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."

References

Visible links
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2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...
6. mailto:[FOI #10328 email]
7. mailto:[email address]
8. mailto:[email address]
9. http://www.tga.gov.au/
10. https://www.facebook.com/TGAgovau/
11. https://twitter.com/TGAgovau
12. https://www.youtube.com/channel/UCem9INJ...
13. mailto:[FOI #10328 email]
14. mailto:[email address]
15. mailto:[FOI #10328 email]
16. mailto:[TGA request email]
17. https://www.righttoknow.org.au/change_re...
18. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Good afternoon Mr Lothbrok

I refer to your email below of 28 August 2023 (below), which was forwarded
to the TGA for response.

As mentioned in our email of 23 August 2023 (attached for reference),
should you wish to seek access to the documents mentioned, it will be
necessary for you to submit a new FOI request. TGA has not received a new
request from.  As mentioned in that correspondence, if you submit a new
request, TGA will be able to process the request expeditiously and without
charge.

In relation to your previous request, as the request was withdrawn and no
decision was issued to you, it is not open to you to submit a request for
internal review.

If you are not satisfied with the TGA’s handling of your request, under
subsection 71(1) of the FOI Act you may submit a complaint to the Office
of the Australian Information Commissioner (OAIC).  Further information
about this process can be found on the OAIC website:
[1]https://www.oaic.gov.au/freedom-of-infor....

Kind regards
Karen

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

[4][IMG][5][IMG][6][IMG]

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. 

-----Original Message-----
From: Ragnar Lothbrok <[FOI #10328 email]>
Sent: Monday, 28 August 2023 11:06 PM
To: FOI <[email address]>
Subject: Internal review of Freedom of Information request - ColoSTAT®
application for an Australian Register of Therapeutic Goods and TGA 26
page response

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear Therapeutic Goods Administration,

Please pass this on to the person who conducts Freedom of Information
reviews.

I am writing to request an internal review of Therapeutic Goods
Administration's handling of my FOI request 'ColoSTAT® application for an
Australian Register of Therapeutic Goods and TGA 26 page response'.

I have not received an answer to my original request to obtain the
COLOSTAT application to the TGA which was subsequently withdrawn

A full history of my FOI request and all correspondence is available on
the Internet at this address:
[7]https://www.righttoknow.org.au/request/c...

Yours faithfully,

Ragnar Lothbrok

-------------------------------------------------------------------

Please use this email address for all replies to this request:

[8][FOI #10328 email]

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[9]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.

-------------------------------------------------------------------

"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."

References

Visible links
1. https://www.oaic.gov.au/freedom-of-infor...
2. mailto:[email address]
3. http://www.tga.gov.au/
4. https://www.facebook.com/TGAgovau/
5. https://twitter.com/TGAgovau
6. https://www.youtube.com/channel/UCem9INJ...
7. https://www.righttoknow.org.au/request/c...
8. mailto:[FOI #10328 email]
9. https://www.righttoknow.org.au/help/offi...

hide quoted sections

Dear Ragnor Lothbrok

Thank you for your subsequent email of 14 September 2023 which has been
forwarded to the TGA for response.

As noted in our correspondence of 23 and 28 August 2023, as your request
was withdrawn and no decision was issued to you, it is not open to you to
submit a request for internal review.

With regard to seeking a review of the handling of your earlier request, I
am satisfied that TGA has provided you with the necessary explanation in
relation to the non-publication of request FOI 4371 and appropriate
guidance in which to move forward in making a new request. If you are not
satisfied with the TGA’s handling of your matter, you may submit a
complaint to the Office of the Australian Information Commissioner
(OAIC).  Further information about this process can be found on the OAIC
website:
[1]https://www.oaic.gov.au/freedom-of-infor....

A decision on the publication of documents subject to FOI requests is made
at the conclusion of the processing of FOI requests and therefore it is
unfortunately not something that is foreshadowed. As you are already
aware, upon completion of the FOI request mentioned in our earlier
correspondence (FOI 4371), a decision was made by the FOI delegate not to
publish the documents relevant to that request pursuant to s11C(1)(b) of
the Freedom of Information Act 1982.

As also previously advised, should you wish to seek access to the
requested document/s, we will be able to process the request expeditiously
and without charge. You may not be aware that the we have recently
implemented a new streamlined online form for submitting an FOI request.
Use of this form will greatly reduce subsequent follow-up emails to
clarify aspects of your request. Should you wish to submit a new FOI
request, please go to the TGA website at the following link to submit your
request: [2]Freedom of information (FOI) | Therapeutic Goods
Administration (TGA) - Submit an FOI request.

Thank you for your time and understanding.

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care

T: 02 6289 4630 | E: [3][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [4]www.tga.gov.au

[5][IMG][6][IMG][7][IMG]

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.

-----Original Message-----

From: Ragnar Lothbrok <[8][FOI #10328 email]>

Sent: Thursday, 14 September 2023 2:17 AM

To: FOI <[9][email address]>

Subject: Internal review of Freedom of Information request - ColoSTAT®
application for an Australian Register of Therapeutic Goods and TGA 26
page response

REMINDER: Think before you click! This email originated from outside our
organisation. Only click links or open attachments if you recognise the
sender and know the content is safe.

Dear Therapeutic Goods Administration,

Please pass this on to the person who conducts Freedom of Information
reviews.

I am writing to request an internal review of Therapeutic Goods
Administration's handling of my FOI request 'ColoSTAT® application for an
Australian Register of Therapeutic Goods and TGA 26 page response'.

No details have been provided with regard to my FOI request on 19 May
2023.  here it is below again.

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
RhythmBiosciences 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.

A full history of my FOI request and all correspondence is available on
the Internet at this address:
[10]https://www.righttoknow.org.au/request/c...

Yours faithfully,

Ragnar Lothbrok

-------------------------------------------------------------------

Please use this email address for all replies to this request:

[11][FOI #10328 email]

This request has been made by an individual using Right to Know. This
message and any reply that you make will be published on the internet.
More information on how Right to Know works can be found at:

[12]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.

-------------------------------------------------------------------

"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."

References

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3. mailto:[email address]
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5. https://www.facebook.com/TGAgovau/
6. https://twitter.com/TGAgovau
7. https://www.youtube.com/channel/UCem9INJ...
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