Pre-registration and registration application information pertaining to the registration of tafenoquine succinate.

Jane Quinn made this Freedom of Information request to Therapeutic Goods Administration

The request was refused by Therapeutic Goods Administration.

From: Jane Quinn

Delivered

Dear Therapeutic Goods Administration,

The new chemical entity (NCE) 'tafenoquine succinate' has recently been approved for registration as a schedule 4 substance on the TGA Poisons Register with effect from 1 February 2018.

https://www.tga.gov.au/book-page/119-taf...

Please can you provide the following information regarding this Schedule 4 approval, and the NCE application (the registration application and pre-submission documents) from which this approval was given:

1. The detailed argument as to why the delegate chose not to consult the Advisory Committee on Medicines Scheduling and any correspondence between the delegate and the Advisory Committee on Medicines Scheduling regarding this matter;

2. The number and nature of all adverse event reports a) submitted for tafenoquine to the TGA adverse events database, and b) the number and nature of those adverse event reports considered at part of the delegates application review process;

3. The detailed consumer (patient) information statements submitted a) as part of the registration application and b) those approved for tafenoquine succinate including dose rates and treatment schedules;

4. The The detailed medical practitioner's information statements a) submitted as part of the registration application and b) those approved for tafenoquine succinate including dose rates and treatment schedules;

5. All information in the application for registration and / or pre-registration documentation relating to requirements for cytochrome P450 (CYP450) screening in patients prior to treatment with tafenoquine succinate, either for prophylaxis or treatment of malaria.

6. All information submitted as part of the pre-submission documentation and the registration application regarding toxicity of tafenoquine succinate in humans, or other non-human species, including in-vitro or pre-clinical data.

I further request that no charge is applied to this FOI application as the information requested is in the public interest and not for commercial purposes.

Yours faithfully,

Dr Jane Quinn
Quinoline Veterans and Families Association

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From: TGA FOI
Therapeutic Goods Administration


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Dear Dr Quinn

 

Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 9 February 2018.

 

We understand the scope of your request to be as follows:

“The new chemical entity (NCE) 'tafenoquine succinate' has recently been
approved for registration as a schedule 4 substance on the TGA Poisons
Register with effect from 1 February 2018.
[1]https://www.tga.gov.au/book-page/119-taf...

Please can you provide the following information regarding this Schedule 4
approval, and the NCE application (the registration application and
pre-submission documents) from which this approval was given:

1. The detailed argument as to why the delegate chose not to consult the
Advisory Committee on Medicines Scheduling and any correspondence between
the delegate and the Advisory Committee on Medicines Scheduling regarding
this matter;

2. The number and nature of all adverse event reports a) submitted for
tafenoquine to the TGA adverse events database, and b) the number and
nature of those adverse event reports considered at part of the delegates
application review process;

3. The detailed consumer (patient) information statements submitted a) as
part of the registration application and b) those approved for tafenoquine
succinate including dose rates and treatment schedules;

4. The detailed medical practitioner's information statements a) submitted
as part of the registration application and b) those approved for
tafenoquine succinate including dose rates and treatment schedules;

5. All information in the application for registration and / or
pre-registration documentation relating to requirements for cytochrome
P450 (CYP450) screening in patients prior to treatment with tafenoquine
succinate, either for prophylaxis or treatment of malaria.

6. All information submitted as part of the pre-submission documentation
and the registration application regarding toxicity of tafenoquine
succinate in humans, or other non-human species, including in-vitro or
pre-clinical data”.

 

Section 15 of the FOI Act requires that a request for access meets certain
requirements.  Your request, in its current form, does not constitute a
valid request as it is a request for information rather than documents.
The FOI Act provides for access to documents and not to 'information'. 
Further, it appears that the scope of your request may be too voluminous
for the TGA to process.

 

In order for your request to be processed under the provisions of the FOI
Act we require further information to enable us to identify the document
or documents you are seeking. 

 

Further Information

To assist us in identifying the documents you seek, and to avoid
submitting a scope that is potentially too voluminous to process, can you
please provide further information in relation to this request. For
example, you may wish to consider the following in relation to the scope
of your request:

 

·         Being more specific with the types of documents you are seeking;
and/or

·         Revise/reduce the number of points in relation to this request;
and/or

·         Revise the scope to the NCE application (the registration
application and pre-submission documents) and supporting documentation
only; and/or

·         Provide a timeframe for the regulatory activity documents you
are seeking (for example 1 December 2017 to date).

 

Please note that at this early stage, the above revisions/reductions are
suggestions only, and the TGA is unable to advise on how many documents
(if any) would be returned if a search and retrieval was conducted.

 

Personal Information

In addition, when providing the further information as requested above,
can you also please clarify if you are seeking 'personal
information'(e.g., the names and/or contact details of any individuals, or
any information that could reasonable identify an individual) of third
parties contained in the documents requested?

 

Confirmation from you that you are not seeking personal information may
enable more timely and less costly processing of your request. For
example, consultation with identified individuals can add to the time and
cost taken to process your request.

 

In relation to departmental staff, we advise the standard approach is that
Commonwealth employee names and contact details below Senior Executive
Service level and mobile telephone numbers of all staff are not released.

 

We would be grateful for your response by COB Monday 19 February 2018.

 

Please don't hesitate to contact the FOI team if you have any questions or
if you would like to discuss this matter.

 

Kind regards,

 

Freedom of Information
(02) 6232 8720

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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From: Jane Quinn

Delivered

Dear TGA FOI,

I apologise for not responding by your very short deadline of 19 February. I have been away from my office and unable to access email until today. I hope that you will still be able to consider my response and act on it accordingly.

I will amend the remit of my FOI request in line with some of the suggestions you have made in your response.

My updated request now states:

Please can you provide the following DOCUMENTS regarding this Schedule 4
approval, and the NCE application (the registration application and
pre-submission documents) from which this approval was given:

1. All documents (email correspondence or other written documentation submitted between January 2008 and February 2018) advising the Advisory Committee that the delegate would not consult with them on this application, including any response from the Advisory Committee to this correspondence;

2. All documents (email correspondence or other written documentation included in the registration application submitted between January 2008 and February 2018) that includes data pertaining to the number and nature of all adverse event reports a) submitted for tafenoquine to the TGA adverse events database, and b) the documentation (email correspondence or other written documentation included in the registration application submitted between January 2008 and February 2018) that contains details of the adverse event reports considered at part of the delegates application review process;

3. Copies of all sections of the registration application form that contain the detailed consumer (patient) information statements submitted which including dose rates and treatment schedules;

4. Copies of all sections of the registration application form that contains the detailed medical practitioner's information statements which includes dose rates and treatment schedules;

5. Copies of all sections of the registration and pre-registration application from for tafenoquine succinate that contains information in the application for registration and / or
pre-registration documentation relating to requirements for cytochrome
P450 (CYP450) screening in patients prior to treatment with tafenoquine
succinate, either for prophylaxis or treatment of malaria.

6. Copies of all sections of the registration application form for tafenoquine succinate submitted as part of the pre-submission documentation
and the registration application regarding toxicity of tafenoquine
succinate in humans, or other non-human species, including in-vitro or
pre-clinical data.

I do not require any personal information to be supplied as part of this FOI request.

Yours sincerely,

Jane Quinn

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From: Jane Quinn

Delivered

Dear TGA FOI,

You have not responded to my request and, by law, you are required to do so promptly.

Can you please either respond immediately with the requested information or inform me as to the date by which you will do so.

Yours sincerely,

Jane Quinn

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From: FOI
Therapeutic Goods Administration

Attention: Jane Quinn

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has received your request (in your below email) for access to documents under the Freedom of Information Act 1982 (FOI Act).

The Department will take all reasonable steps to notify you of a decision no later than 30 calendar days after the date your request was received. You will be contacted where a charge is applied for processing your request or if we need to consult a third party.

Unless you advise otherwise, duplicate documents and Commonwealth employee names and contact details below Senior Executive Service level and mobile telephone numbers of all staff will be excluded from the scope of your request under s22(1)(a)(ii) of the FOI Act.

You can contact the FOI Unit on (02) 6289 1666, or via email at [email address], should you have any enquiries.

Regards

FOI Unit

Legal Advice & Legislation Branch
Legal & Assurance Division
Australian Government Department of Health
T: (02) 6289 1666 | E: [TGA request email]

PO Box 9848, Canberra ACT 2601, Australia

The Department of Health acknowledges the traditional owners of country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to elders both past and present.

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From: TGA FOI
Therapeutic Goods Administration


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Attachment D18 10384473 FOI208 1718 Request Consultation Process Letter 24AB.PDF.pdf
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Dear Ms Quinn,

 

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
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

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

 

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From: Jane Quinn

Delivered

Dear TGA FOI,

In response to your letter of 21 March, please can I amend my request as follows:

The new chemical entity (NCE) 'tafenoquine succinate' has recently been approved for registration as a schedule 4 substance on the TGA Poisons Register with effect from 1 February 2018.

Please can you provide the following information regarding this Schedule 4 approval, and the NCE application (the registration application and pre-submission documents) from which this approval was given:

1. The number and nature of all adverse event reports a) submitted for tafenoquine to the TGA adverse events database, and b) the number and nature of those adverse event reports considered at part of the delegates application review process;

2. The detailed consumer (patient) information statements submitted a) as part of the registration application and b) those approved for tafenoquine succinate including dose rates and treatment schedules;

3. All information in the application for registration and / or pre-registration documentation relating to requirements for cytochrome P450 (CYP450) screening in patients prior to treatment with tafenoquine succinate, either for prophylaxis or treatment of malaria.

I further request that no charge is applied to this FOI application as the information requested is in the public interest and not for commercial purposes.

I hope this request will now sits within a respectable workload remit meaning that this documentation can then be provided.

Yours sincerely,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Quinn,

 

We refer to our correspondence of 21 March 2018 (copy below).

 

In our correspondence you were provided with written notice that under
section 24AB of the FOI Act a Request Consultation Process was to be
undertaken and you were provided with an opportunity to refine the scope
of your request.

 

You were further advised that you had fourteen (14) calendar days, under
section 24AB(6) of the FOI Act, to either:

(a)    Withdraw your request;

(b)   Make a revised request; or

(c)    Indicate that you do not wish to revise your request.

 

You were also advised that if you failed to contact the TGA, in writing,
within that timeframe to do one of the above, or to consult the TGA to
discuss revising the scope, your request is taken to have been withdrawn. 

 

To date, the TGA has not received a response from you in relation to the
Request Consultation Process.

 

Accordingly, your FOI request is taken to have been withdrawn pursuant to
section 24AB(6) of the FOI Act, and no further action will be taken in
relation to your request.

 

If you would still like to pursue your matter, you will need to lodge a
new FOI request with the Department.

 

Kind regards,

 

Freedom of Information
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

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

 

From: TGA FOI
Sent: Wednesday, 21 March 2018 4:17 PM
To: 'Jane Quinn'
Cc: TGA FOI
Subject: FOI208-1718 Request Consultation Process [SEC=UNCLASSIFIED]

 

Dear Ms Quinn,

 

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
(02) 6232 8720

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

 

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

 

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From: Jane Quinn

Delivered

Dear TGA FOI,

I did respond to your information on 21 March on 23rd March, in which I amended the scope of my request.

Please can you review this information and respond accordingly.

Yours sincerely,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration

Dear Ms Quinn,

Thank you for your email.

The TGA has no record of any correspondence from you dated 23 March 2018. The last received correspondence the TGA has recorded from you is dated 14 March 2018.

We have further confirmed with our IT Department that no emails have been mistakenly blocked by our IT security system.

As this matter has been deemed withdrawn under section 24AB(6) of the FOI Act, if you wish to pursue your matter you will need to lodge a new request with the Department.

Kind regards,

Freedom of Information
(02) 6232 8720
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: Jane Quinn

Delivered

Dear TGA FOI,

Please send me an email that I can forward screenshots of my message to you of 23rd March. I can clearly see them in this thread.

Do not close this request, I have responded to your request and this can clearly be seen in your system.

Yours sincerely,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration

Dear Ms Quinn,

As previously advised in our emails of 5 and 6 April 2018, we do not have any record of correspondence from you, either electronic or hard copy, dated 23 March 2018.

We send and receive all correspondence via email ([email address]). We are unaware of the "thread" you are referring to.

As advised in our email of 6 April 2018, we have confirmed with our IT Department that no emails from you have been mistakenly blocked by our IT security system.

We reiterate again, as this matter has been deemed withdrawn under section 24AB(6) of the FOI Act, it cannot be progressed further.

However, if you provide us the request you would like the TGA to consider, we can take it as a new request for the purposes of the FOI Act.

Kind regards,

Freedom of Information
(02) 6232 8720
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

Dear TGA FOI,

Please send me an email that I can forward screenshots of my message to you of 23rd March. I can clearly see them in this thread.

Do not close this request, I have responded to your request and this can clearly be seen in your system.

Yours sincerely,

Jane Quinn

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From: Jane Quinn

Delivered

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 'Pre-registration and registration application information pertaining to the registration of tafenoquine succinate.'.

Despite my responses to your requests being clearly visible on the righttoknow.org.au website you refused my request on the grounds that you did not receive my response. This is illogical and incorrect.

I formally request that the process of this particular FOI be reviewed internally and an adequate explanation given for the failure of your department to effectively use the system designated for correspondence in this process.

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

Particularly, please note my responses in this information trail of 23 March and 5 April.

Yours faithfully,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration

Dear Miss Quinn,

We refer to your email 17 April 2018 (copy below).

We advise that the TGA does not utilise the right to know platform outlined in your correspondence and we were not aware that you had responded to our letter through that website.

As advised in our emails of 5 and 6 April 2018, the TGA did not receive any email or hard copy correspondence from you in response to the Request Consultation Process dated 21 March 2018. The TGA has no record of any correspondence, either electronic or hard copy, from you dated 23 March 2018. We also advise that we have confirmed with our IT Department that no emails have been mistakenly blocked by our IT security system.

The FOI Act provides for the internal review of FOI decisions. However, as your matter was taken to have been withdrawn under section 24AB(7) of the FOI Act, no 'decision' has been made under the FOI Act and therefore there is no provision for an internal review under the FOI Act. You can, however, make a complaint about the handling of your FOI to the Information Commissioner. See https://www.oaic.gov.au/freedom-of-infor... .

We again reiterate:
- the TGA does not utilise the right to know platform to correspond with applicants - the TGA only communicates via email, post, or telephone.
- the TGA does not have a record of any correspondence from you, either electronic or hard copy, dated 23 March 2018.
- your FOI matter 208-1718 was taken to have been withdrawn under section 24AB(7) of the FOI Act, however, we are now processing a further FOI request from you (FOI275-1718).
- as your matter was deemed withdrawn, no 'decision' has been made under the FOI Act and, therefore, there is no provision under the FOI Act for an internal review. However, you can make a complaint to the Information Commissioner.

Kind regards,

Freedom of Information
(02) 6232 8720
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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