Reports used for the approval of Diphtheria, Pertussis and Tetanus vaccines.

Shanna Miller made this Freedom of Information request to Therapeutic Goods Administration

The request was refused by Therapeutic Goods Administration.

From: Shanna Miller

Delivered

Dear Therapeutic Goods Administration,

I hereby request the release of documents held by the Therapeutic Goods Association for the purposes of Freedom of Information Act 1982.

Documents requested:

All reports providing evidence of safety and efficacy that were used to approve the licensure of the Infanrix hexa, Infanrix IPV, Quadracel and Boostrix vaccines.
Please also include the above requested reports for any previous versions of vaccines for Pertussis, Diphtheria and Tetanus, not currently on the NIP.

Yours faithfully,

Shanna Miller

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From: Shanna Miller

Delivered

Dear Therapeutic Goods Administration,

In addition to the previous requested reports, I also require the same for the Infanrix and Tripacel vaccines.

Yours faithfully,

Shanna Miller

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From: TGA FOI
Therapeutic Goods Administration


Attachment image001.png
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Dear Ms Miller

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) for access to documents under the Freedom
of Information Act 1982 (FOI Act) as follows:

"I hereby request the release of documents held by the Therapeutic Goods
Association for the purposes of Freedom of Information Act 1982.

 

Documents requested:

 

All reports providing evidence of safety and efficacy that were used to
approve the licensure of the Infanrix hexa, Infanrix IPV, Quadracel,
Boostrix, Infanrix, and Tripacel vaccines.

 

Please also include the above requested reports for any previous versions
of vaccines for Pertussis, Diphtheria and Tetanus, not currently on the
NIP."

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 September 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 19 August 2019.

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

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: [2][email address]

 

[3]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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From: TGA FOI
Therapeutic Goods Administration


Attachment D18 10395235 ATTACHMENT A Request Consultation Process.PDF.pdf
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Attachment D19 6074073 FOI 1277 Request consultation.PDF.pdf
257K Download View as HTML


Dear Ms Miller

 

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

 

As set out in the attached correspondence, we seek your response within 14
days, being 24 September 2019.

 

Pursuant to section 24AB(8) of the Freedom of Information Act 1982, the
statutory timeframe for processing your request is set aside during this
consultation process.

 

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

 

Kind regards

Kyla

 

Freedom of Information
Kyla | Karen | Tara | Cindy

(02) 6289 4630

Therapeutic Goods Administration

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

 

 

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Things to do with this request

Anyone:
Therapeutic Goods Administration only: