Copies of documents relating to correspondence between the TGA and UCB Australia in 2018 containing the keywords ‘Sodium Oxybate’ and/or ‘Xyrem’

Anne Williams made this Freedom of Information request to Therapeutic Goods Administration

The request was successful.

From: Anne Williams

Delivered

Dear Therapeutic Goods Administration,

I am interested in obtaining copies of documents relating to correspondence between the Therepeutic Goods Administration (TGA) and pharmaceutical company UCB Australia, that took place in 2018, pertaining to keywords ‘Sodium Oxybate’ or ‘Xyrem’.

Is this possible to process under the administrative access request? If not I would like to make a Freedom of Information application.

Yours faithfully,
Ann Williams

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Williams

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).

“…copies of documents relating to correspondence between the Therapeutic
Goods Administration (TGA) and pharmaceutical company UCB Australia, that
took place in 2018, pertaining to keywords ‘Sodium Oxybate’ or ‘Xyrem’.

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 15 AUGUST 2019.

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 Information

Documents containing personal 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 information in the documents (e.g. names, contact
details, addresses) relating to:

·         third parties; and

·         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 information, you can simply
reply: 'no personal information requested'.

 

If you are seeking access to specific types of personal information,
please specify the type of personal 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 19 July 2019.

If you have any queries, please contact the FOI team on (02) 6232 8806, or
via email at [1][email address].

Kind regards

Tara

 

Freedom of Information
(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [2][email address]

 

[3]cid:image001.png@01D1D5D9.7DDEADA0

 

 

 

 

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Link to this

From: TGA FOI
Therapeutic Goods Administration


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Attachment FOI 1226 Estimate of Charges.pdf
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Attachment credit card payment authorisation.pdf
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Dear Ms Williams

 

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

 

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 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

Karen

 

Freedom of Information
(02) 6232 8806

Therapeutic Goods Administration

Department of Health
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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 Owners and
Custodians of country throughout Australia and their continuing connection
to land, waters and community. We pay our respect to them and their
cultures, and to elders past, present and future.

 

 

 

 

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From: Anne Williams

Delivered

Dear TGA FOI,

Thank you for your response, I am not seeking access to any personal information of any individual, or duplicate copies in any format. I am not seeking anything that would be considered commercial in-confidence.

To clarify further, I am seeking only documents relating to correspondence between the TGA and UCB Australia related directly to pre-submission discussions about the drug Xyrem (Sodium Oxybate). These discussions took place in 2018 and written advice was provided by email from TGA to UCB Australia. I refer specifically to the two pre-submission discussions that are described on page 2 of, "Inquiry into Sleep Health Awareness in Australia - Submission 131 - Supplementary Submission 1," which is uploaded at:

https://www.aph.gov.au/Parliamentary_Bus...

"The TGA has been approached in 2018 by potential sponsors for sodium oxybate and has had two pre-submission discussions. Written advice to the sponsors was provided by the TGA at the time and no follow-up applications have been received to date."

I understand further that some of the documents relating to these discussions may be published journal articles or studies. If the documents contain information that is published elsewhere I am not seeking it to be reproduced in full, I am only seeking a citation or reference information so that it is identified.

Given the above, can you please advise given the above what the adjusted new estimate of charges will be?

Yours sincerely,

Anne Williams

Link to this

From: TGA FOI
Therapeutic Goods Administration

Dear Ms Williams

I refer to your email below, in which you wish to contend that the charges sent to you on 25 July 2019 have been wrongly assessed.

I have reviewed the documents relevant to your request, and all of the documents fall within the scope of the documents you are seeking. There are 127 relevant pages, which include multiple third parties that require consultation.

On this basis, the estimate of charges remains the same.

As stated in our correspondence of 25 July 2019, under subsection 29(1) of the FOI Act, you have 30 days from receipt of that notice to:
- pay the charge, being the deposit or full amount;
- notify the TGA that you wish to contend that the charge should be reduced or not imposed on the grounds of financial hardship or public interest, or other grounds, and give reasons;
- notify the TGA that you withdraw your request.

If you have any questions, please contact the FOI team.

Kind regards
Heather

Freedom of Information
(02) 6232 8806
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

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From: Anne Williams

Delivered

Dear TGA FOI,

Thank you for your advice. Given this, I am amending my request to only include documentation that is the actual 'written advice' provided to UCB Australia by the TGA in regards to the aforementioned pre-submission discussions. I am not requesting correspondence related to or surrounding that written advice.

Please advise the updated estimate of charges in regards to this request.

Yours sincerely,

Anne Williams

Link to this

From: TGA FOI
Therapeutic Goods Administration

Dear Ms Williams

I regret that your request to amend the scope of your FOI has fallen outside of the 30 day period outlined below (and contained in the Estimate of Charges letter of 25 July 2019). This period expired on 24 August 2019 and as we had not received a response from you, the matter was finalised.

You are welcome to submit a new FOI with your new scope.

Please let us know if you have any questions.

Thank you

Kyla

Freedom of Information
(02) 6289 4630
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

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From: Anne Williams

Delivered

Dear TGA FOI,

Consider this my new request

Yours sincerely,

Anne Williams

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Williams

 

Thank you for your email of 12 September 2019.

 

Below is a scope based on your latest advice and your previous FOI request
– FOI 1226:

 

“I am seeking copies of documents relating to actual 'written advice'
provided to UCB Australia by the TGA that took place in 2018, pertaining
to keywords ‘Sodium Oxybate’ or ‘Xyrem’ in regards to the pre-submission
discussions for this product.

 

I am not requesting correspondence related to or surrounding that written
advice.”

 

Could you please confirm that this scope accurately captures what
documents you seek by COB Monday 16 September 2019.

 

Kind regards

 

Freedom of Information
+61 (0)2 6289 4630

Therapeutic Goods Administration

Australian Government Department of Health
Address: PO Box 100, Woden ACT 2606, Australia
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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.

 

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Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Williams

 

I refer to the email below regarding your FOI request – FOI 1324.

 

As we have not received a response from you, we will continue processing
your request based on the scope below:

 

“I am seeking copies of documents relating to actual 'written advice'
provided to UCB Australia by the TGA that took place in 2018, pertaining
to keywords ‘Sodium Oxybate’ or ‘Xyrem’ in regards to the pre-submission
discussions for this product.

 

I am not requesting correspondence related to or surrounding that written
advice.”

 

Please note: At this early stage, a search and retrieval has not been
conducted and the TGA is unable to advise on whether it may be too
voluminous to process or if any documents will be returned.

 

Kind regards

 

Freedom of Information
+61 (0)2 6289 4630

Therapeutic Goods Administration

Australian Government Department of Health
Address: PO Box 100, Woden ACT 2606, Australia
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

 

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.

 

From: TGA FOI <[email address]>
Sent: Friday, 13 September 2019 3:42 PM
To: 'Anne Williams' <[FOI #5519 email]>
Cc: TGA FOI <[email address]>
Subject: New FOI request - FOI 1324 Sodium Oxybate or Xyrem [SEC=OFFICIAL]

 

Dear Ms Williams

 

Thank you for your email of 12 September 2019.

 

Below is a scope based on your latest advice and your previous FOI request
– FOI 1226:

 

“I am seeking copies of documents relating to actual 'written advice'
provided to UCB Australia by the TGA that took place in 2018, pertaining
to keywords ‘Sodium Oxybate’ or ‘Xyrem’ in regards to the pre-submission
discussions for this product.

 

I am not requesting correspondence related to or surrounding that written
advice.”

 

Could you please confirm that this scope accurately captures what
documents you seek by COB Monday 16 September 2019.

 

Kind regards

 

Freedom of Information
+61 (0)2 6289 4630

Therapeutic Goods Administration

Australian Government Department of Health
Address: PO Box 100, Woden ACT 2606, Australia
Email: [3][email address]

 

[4]cid:image001.png@01D1D5D9.7DDEADA0

 

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.

 

show quoted sections

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From: Anne Williams

Delivered

Dear TGA FOI,

Please hold on processing my request until I respond to your question. Your question limited the scope of my request by only taking into account a small part of our correspondence.

I will respond to your request for clarification within the timeframe provided to me.

Yours sincerely,

Anne Williams

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Williams

 

Thank you for your email.

 

If you wish to make changes to the scope of your request, could you please
advise by Tuesday 24 September 2019.

 

If we do not hear from you by this date, TGA will continue processing
based on the following scope:

 

“I am seeking copies of documents relating to actual 'written advice'

provided to UCB Australia by the TGA that took place in 2018, pertaining 
to keywords ‘Sodium Oxybate’ or ‘Xyrem’ in regards to the pre-submission 
discussions for this product.

 

I am not requesting correspondence related to or surrounding that written 
advice.”

 

Kind regards

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

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

PO Box 100, Woden ACT 2606, Australia

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

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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. 

 

show quoted sections

Link to this

From: Anne Williams

Delivered

Dear TGA FOI,

Is there a particular part of FOI law that you are picking these deadlines from? I didn't realise you can assign arbitrary deadlines for me to respond by when I already advised I will respond and intend to clarify.

I am seeking documentation that is the actual 'written advice' provided to UCB Australia by the TGA in regards to the aforementioned pre-submission discussions. I am not requesting any other correspondence related to or surrounding that written advice.

The 'written advice' refers to part of the correspondence between the TGA and UCB Australia related directly to pre-submission discussions about the drug Xyrem (Sodium Oxybate). These discussions took place in 2018 and written advice was provided by email from TGA to UCB Australia. I refer specifically to the two pre-submission discussions that are described on page 2 of, "Inquiry into Sleep Health Awareness in Australia - Submission 131 - Supplementary Submission 1," which is uploaded at:

https://www.aph.gov.au/Parliamentary_Bus...

"The TGA has been approached in 2018 by potential sponsors for sodium oxybate and has had two pre-submission discussions. Written advice to the sponsors was provided by the TGA at the time and no follow-up applications have been received to date."

I understand further that some of the documents relating to these discussions may be published journal articles or studies. If the documents contain information that is published elsewhere I am not seeking it to be reproduced in full, I am only seeking a citation or reference information so that it is identified.

I am not seeking access to any personal information of any individual, or duplicate copies in any format. I am not seeking anything that would be considered commercial in-confidence.

Yours sincerely,

Anne Williams

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Williams

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 seeking documentation that is the actual 'written advice' provided
to UCB Australia by the TGA in regards to the aforementioned
pre-submission discussions. I am not requesting any other correspondence
related to or surrounding that written advice.

 

The 'written advice' refers to part of the correspondence between the TGA
and UCB Australia related directly to pre-submission discussions about the
drug Xyrem (Sodium Oxybate). These discussions took place in 2018 and
written advice was provided by email from TGA to UCB Australia. I refer
specifically to the two pre-submission discussions that are described on
page 2 of, "Inquiry into Sleep Health Awareness in Australia - Submission
131 - Supplementary Submission 1," which is uploaded at:

 

[1]https://www.aph.gov.au/Parliamentary_Bus...

 

"The TGA has been approached in 2018 by potential sponsors for sodium
oxybate and has had two pre-submission discussions. Written advice to the
sponsors was provided by the TGA at the time and no follow-up applications
have been received to date."

 

I understand further that some of the documents relating to these
discussions may be published journal articles or studies. If the documents
contain information that is published elsewhere I am not seeking it to be
reproduced in full, I am only seeking a citation or reference information
so that it is identified.

 

I am not seeking access to any personal information of any individual, or
duplicate copies in any format. I am not seeking anything that would be
considered commercial in-confidence.”

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 12 October 2019.

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.

If you have any queries, please contact the FOI team on (02) 6232 8806, or
via email at [2][email address].

Kind regards

 

Freedom of Information

[3]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [4][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [5]www.tga.gov.au

 

[6]cid:image002.png@01D55CBC.5655D390[7]cid:image003.gif@01D55CBC.5655D390[8]cid:image004.png@01D55CBC.5655D390

 

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. 

 

show quoted sections

Link to this

From: Anne Williams

Delivered

Dear TGA FOI,

Please advise the date you calculate the 30 day extension to be until? I'm not sure if it's inclusive of day 30, etc.

Yours sincerely,

Anne Williams

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Williams

 

Thank you for your email.

 

Under section 15(5)(b) of the Freedom of Information Act 1982 (FOI Act),
the agency has 30 days in which to provide a decision in response to your
FOI request.

 

However, this timeframe may be affected by the requirement to undertake
consultation with effected third parties and if the agency determines you
are liable to pay a charge in relation to your request.

 

You will be notified by the agency if charges are liable or if third party
consultation is required.

 

The current due date for your request is 12 October 2019.

 

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

 

Kind regards

Karen

 

Freedom of Information

Kyla | Karen | Tara | Cindy

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

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

PO Box 100, Woden ACT 2606, Australia

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

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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. 

 

show quoted sections

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Attachment credit card payment authorisation.pdf
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Attachment FOI 1324 Estimate of Charges.pdf
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Dear Ms Williams

 

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

 

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 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

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

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

PO Box 100, Woden ACT 2606, Australia

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

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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.

 

 

show quoted sections

Link to this

From: Anne Williams

Delivered

Dear TGA FOI,

I have paid via bank transfer as requested. The account is Bank SA so I'm not sure how long it will take to come through.

Yours sincerely,

Anne Williams

Link to this

From: Anne Williams

Delivered

Dear TGA FOI,

Please advise if you received my bank transfer?

Yours sincerely,

Anne Williams

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Williams

 

I can confirm that your payment has been received and we are processing
your request.  Please find attached a receipt for your payment.

 

A decision is currently due on or before 12 November.

 

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

 

Kind regards
Karen

 

Freedom of Information

Kyla | Karen | Tara | Cindy

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

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

PO Box 100, Woden ACT 2606, Australia

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

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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. 

 

 

 

show quoted sections

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Attachment ATTACHMENT A.pdf
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Attachment credit card payment authorisation.pdf
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Attachment Review Rights.pdf
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Dear Ms Williams

 

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

 

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

 

Kind regards

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

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

PO Box 100, Woden ACT 2606, Australia

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

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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.

 

 

show quoted sections

Link to this

From: Anne Williams

Delivered

Dear TGA FOI,

Thank you for emailing your decision.

Please advise if given the third party has 30 days to submit an appeal, if I pay the remaining fee now and the appeal is successful, do I forfeit the fees paid (and the previous fees paid)?

Is there any further waiting period added if I do not pay the remaining fee, even though there is already a waiting period that is outside of my control?

I am interested in paying the remaining fee and obtaining the documents, as I now have to wait a further 30 days regardless, please advise what the consequence is if I pay now versus at the end of the appeal period?

Please also advise what notification I will receive of an appeal bring submitted, e.g. if one is submitted in 3 days, will you advise me, or wait until the 30 day period?

Yours sincerely,

Anne Williams

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From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Williams

 

Thank you for your email.

 

I can confirm that payment of the remaining fee, and the deposit already
paid, are not subject to a refund. This is because the charges reflect the
actual time spent processing the FOI request in accordance with the
[1]Freedom of Information (Charges) Regulations 2019. This is independent
of the outcome of any review.

 

If a request for review is lodged, you will be advised at that time and
not at the conclusion of the 30 day period. However the documents cannot
be released to you until that decision is made, and if the decision is
affirmed, any balance payment is processed. If no review is lodged, no
further waiting periods apply, subject to the processing of any remaining
payment.

 

Please let us know if you have any further questions.

 

Thank you

 

Freedom of Information

[2]cid:image001.png@01D54DDB.C1CF42E0

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]cid:image002.png@01D55CBC.5655D390[6]cid:image003.gif@01D55CBC.5655D390[7]cid:image004.png@01D55CBC.5655D390

 

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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From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Williams

 

I am writing to advise that the review rights period has now expired and
no request for review has been received from the third party relevant to
your FOI request.

 

As such, if you wish to receive the documents relating to your FOI request
you will be required to pay the balance of charges being $41.82.

 

Kind regards
Karen

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

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

PO Box 100, Woden ACT 2606, Australia

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

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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. 

 

 

 

show quoted sections

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From: Anne Williams

Delivered

Dear TGA FOI,

I have paid the remaining balance. Can you please confirm that the documents will be supplied electronically?

Yours sincerely,

Anne Williams

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Williams

 

Once we receive confirmation of the payment from our Accounts area, the
documents will be released electronically.

 

Kind regards
Karen

 

Freedom of Information

Kyla | Karen | Tara | Cindy

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

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

PO Box 100, Woden ACT 2606, Australia

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

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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. 

 

show quoted sections

Link to this

From: TGA FOI
Therapeutic Goods Administration


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Attachment Document 1 AR.pdf
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Attachment Document 2 AR.pdf
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Dear Ms Williams

 

As the TGA has received the balance of the amount owing for the processing
of your request I am now releasing the documents to you. Please find
attached a copy of the relevant documents.

 

If you have any queries regarding this matter, please do not hesitate to
contact the FOI team.

 

Kind regards

Karen

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

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

PO Box 100, Woden ACT 2606, Australia

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

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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: Friday, 13 December 2019 4:14 PM
To: Anne Williams <[FOI #5519 email]>
Cc: TGA FOI <[email address]>
Subject: RE: FOI 1324 - Expiration of review rights [SEC=OFFICIAL]

 

Dear Ms Williams

 

Once we receive confirmation of the payment from our Accounts area, the
documents will be released electronically.

 

Kind regards
Karen

 

Freedom of Information

Kyla | Karen | Tara | Cindy

[7]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [8][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [9]www.tga.gov.au

 

[10]cid:image002.png@01D55CBC.5655D390[11]cid:image003.gif@01D55CBC.5655D390[12]cid:image004.png@01D55CBC.5655D390

 

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. 

 

show quoted sections

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