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FOI request: MundiPharma infringment notices

Alexander made this Freedom of Information request to Therapeutic Goods Administration

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Dear Therapeutic Goods Administration,

my name is Alexander and I am making this request under the FOI Act.

I am requesting copies of all infringement notices issued from TGA to Mundipharma Pty Ltd since January 1 2012, including but not limited to the 24 notices mentioned in this article: https://www.tga.gov.au/media-release/mun...

I am requesting that any access charges relating to this request be waived as this request is in the public interest and is published on the righttoknow.org.au website.

Yours faithfully,

Alexander

TGA FOI, Therapeutic Goods Administration

4 Attachments

Dear Alexander

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has
received your request for access to documents under the Freedom of
Information Act 1982 (FOI Act) as follows:

                “I am requesting copies of all infringement notices issued
from TGA to Mundipharma Pty Ltd since January 1 2012, including but not
limited to the 24 notices mentioned in this article:
[1]https://www.tga.gov.au/media-release/mun...

I am requesting that any access charges relating to this request be waived
as this request is in the public interest and is published on the
righttoknow.org.au website.”

 

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
after the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 6 April 2022.

However, where there is 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.

 

PROCESSING YOUR REQUEST

To assist us to streamline the processing of your request we ask you to
consider and respond to the following questions.

 

 1. Personal/Third party Information

Documents containing personal/third party information, (e.g. the names and
contact details of any individuals, or any information that could
reasonably identify an individual) may require the Department to consult
with the identified individuals or parties. This consultation is likely to
add to the time taken to process your request, and potentially increase
the charge imposed on you.

 

We would therefore be grateful if you could confirm if you are seeking
access to personal/third party information in the documents (e.g. names,
contact details, addresses) relating to:

o third parties; and
o Commonwealth staff (please note that unless you advise otherwise, we
will assume that you do not seek access to personal information of
Commonwealth employees below Senior Executive Service level).

 

If you are not seeking access to any personal/third party information, you
can simply reply: 'no personal/third party information requested'.

 

If you are seeking access to specific types of personal information,
please specify the type of personal/third party information you require.

 

 2. Duplicate Documents

Under section 4(1) of the FOI Act, the definition of a document includes
‘any copy, including an part of any copy, of a reproduction or duplicate’.
Confirmation that you are not seeking duplicate documents may enable more
timely and less costly processing of your request.

 

Can you please clarify if you are seeking duplicate copies, either in part
or in full, as part of your request?

 

If you are not seeking access to duplicate documents, you can simply
respond: ‘no duplicates requested’.

 

We look forward to hearing from you by COB Friday 18 March 2022.

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [2][email address].

Kind regards

 ​

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

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.  

 

 

 

"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.tga.gov.au/media-release/mun...
2. mailto:[email address]
3. mailto:[email address]
4. http://www.tga.gov.au/
5. https://www.facebook.com/TGAgovau/
6. https://twitter.com/TGAgovau
7. https://www.youtube.com/channel/UCem9INJ...

Dear TGA FOI,

no personal/third party information requested, unless the infringement notices themselves are considered "third party information".

no duplicates requested, unless the only extant form of the requested documents are considered "duplicates".

Yours sincerely,

Alexander

TGA FOI, Therapeutic Goods Administration

6 Attachments

​Dear Alexander

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

We note in your email of 7 March 2022, you sought a full waiver of any
fees associated with the processing of your FOI request on the ground of
public interest. Pursuant to section 29(1)(f) of the FOI Act, you have 30
days after the issuance of this notice to seek a waiver of charges. If you
still intend to seek a full waiver of the charges, please confirm in
writing and provide any additional information you wish the TGA to
consider in support of your claim.

 

Consultation

As your request relates to the personal, professional, business,
commercial or financial affairs of third parties, pursuant to section 27
and 27A of the FOI Act, the TGA is required to consult with the affected
third parties and provide them an opportunity to make submissions
regarding the release of the documents.

 

Accordingly, under section 15(6) of the FOI Act, and upon payment of a
deposit, the timeframe for processing your request will be extended by 30
days to allow the consultation process to be conducted.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

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. 

 

 

"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. mailto:[email address]
2. http://www.tga.gov.au/
3. https://www.facebook.com/TGAgovau/
4. https://twitter.com/TGAgovau
5. https://www.youtube.com/channel/UCem9INJ...

TGA FOI, Therapeutic Goods Administration

5 Attachments

Dear Alexander

 

I refer to the Estimate of Charges letter dated 29 March 2022 (attached)
relating to your request FOI 3673.

 

I write to advise you that your request was deemed withdrawn, as no
response or payment was received within the legislated timeframe notified
in the Estimate of Charges letter.

 

Should you have any questions regarding this matter, please do not
hesitate to contact the TGA FOI team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

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: TGA FOI <[email address]>
Sent: Tuesday, 29 March 2022 3:54 PM
To: [FOI #8568 email]
Cc: TGA FOI <[email address]>
Subject: FOI 3673 - Notice of Estimate of Charges

 

​Dear Alexander

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

We note in your email of 7 March 2022, you sought a full waiver of any
fees associated with the processing of your FOI request on the ground of
public interest. Pursuant to section 29(1)(f) of the FOI Act, you have 30
days after the issuance of this notice to seek a waiver of charges. If you
still intend to seek a full waiver of the charges, please confirm in
writing and provide any additional information you wish the TGA to
consider in support of your claim.

 

Consultation

As your request relates to the personal, professional, business,
commercial or financial affairs of third parties, pursuant to section 27
and 27A of the FOI Act, the TGA is required to consult with the affected
third parties and provide them an opportunity to make submissions
regarding the release of the documents.

 

Accordingly, under section 15(6) of the FOI Act, and upon payment of a
deposit, the timeframe for processing your request will be extended by 30
days to allow the consultation process to be conducted.

 

If you have any questions, please do not hesitate to contact the FOI Team.

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [6][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [7]www.tga.gov.au

 

[8][IMG][9][IMG][10][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. 

 

 

"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. mailto:[email address]
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:[email address]
7. http://www.tga.gov.au/
8. https://www.facebook.com/TGAgovau/
9. https://twitter.com/TGAgovau
10. https://www.youtube.com/channel/UCem9INJ...

We don't know whether the most recent response to this request contains information or not – if you are Alexander please sign in and let everyone know.