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This is an HTML version of an attachment to the Freedom of Information request 'Therapeutic Goods Administration Approvals for Australian Defence Force Use of Tafenoquine in Bougainville and Timor Leste, 1999-2001'.

Date: Fri, 08 Jul 2016 02:13:07 +0000
Subject: FW: FOI222-1516 - Tafenoquine [SEC=UNCLASSIFIED]
From: TGA FOI <xxx.xxx@xxx.xxx.xx>
To: Brandon Chen <xxxxxxx.xxxx@xxxx.xxx.xx>
Cc: TGA FOI <xxx.xxx@xxx.xxx.xx>

Dear Brandon

As discussed, I have just had a conversation with Mr McCarthy about his FOI request.
His email address for your reference is: xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx

Mr McCarthy was comfortable with the time taken to process his request and acknowledged the complexity of the matter.
I indicated to him that the search and retrieval was in final stages and a charges estimate would be issued in the next few days.

As discussed, given the age of the documents, approx. 50 hard copy files and 2000 electronic documents will need to be searched for individual requests for this request.
Once complete the documents will also need to be reviewed by an expert specialist.

Additionally, the TGA will need to consult defence and other government agencies on the sensitive information in the documents.
I explained all these issues to Mr McCarthy this morning also.

As discussed, the TGA would be grateful for an additional extension of 21 days (due date 29 July 2016).

Thank you for your consideration of our request.

Kind regards
Liz

Elizabeth Santolin
Assistant Director – FOI Team
Reporting and Collaboration Services
Regulatory Engagement & Planning Branch
Phone: 02 6232 8664

Health Products Regulation Group
Department of Health
PO Box 100
Woden ACT 2606 Australia
www.tga.gov.au


-----Original Message-----
From: TGA FOI
Sent: Friday, 8 July 2016 10:59 AM
To: 'Stuart McCarthy'; TGA FOI
Subject: RE: FOI222-1516 - Tafenoquine [SEC=UNCLASSIFIED]

Dear Mr McCarthy

As discussed, please provide information regarding additional clinical trial site and I will discuss with the relevant area of the TGA.

Kind regards
Liz

Freedom of Information
Reporting and Collaborative Services Section Regulatory Engagement and Planning Branch Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: xxx.xxx@xxx.xxx.xx



-----Original Message-----
From: Stuart McCarthy [mailto:xxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx]
Sent: Friday, 13 May 2016 4:59 PM
To: TGA FOI
Subject: Re: FOI222-1516 - Tafenoquine [SEC=UNCLASSIFIED]

Dear TGA FOI staff,

Thankyou for your helpful reply. The refined scope that you suggest in your email is exactly the information I am seeking. The background and references in my initial email should hopefully assist with a file search, specifically the documented use of tafenoquine by the ADF during clinical trials conducted in Bougainville (Papua New Guinea) 1999 and Timor Leste (formerly East Timor) 2000-01, noting that the drug was also administered to those personnel in Australia immediately prior to and after their deployment to those countries.

Another smaller tafenoquine study was conducted by the ADF during this period. That study was for tafenoquine in the treatment of recurrent vivax malaria. Given that TGA documents relating to that study have recently been made public via the media I do not need access to those documents via this FOI request.

I confirm the following scope of this request:

I hereby request the TGA to provide documents relating to any approvals for the ADF or Department of Defence to administer tafenoquine to Australian personnel during 1999-2001, specifically:

a. Requests from ADF or Defence officials for TGA approval to use tafenoquine.

b. Minutes of meetings, records of conversations, or other correspondence between TGA and Defence officials, relating to such requests.

c. Internal TGA correspondence relating to proposed Defence use of tafenoquine, including minutes of meetings, records of conversation or emails.

d. Correspondence between TGA officials and GlaxoSmithKline relating to the proposed use of tafenoquine.

e. Written approvals by the TGA for Defence use of tafenoquine.

f. Reports from Defence officials to the TGA relating to adverse events experienced by ADF personnel administered tafenoquine during this period.

In terms of prioritising this request, the most important documents I am seeking are any requests from ADF or Defence officials (item "a" above) and any written approvals (or denials) of those requests by the TGA (item "e") above. I would be happy to further revise this overall FOI request once we have determined whether such documents do or do not exist in TGA records.

Thankyou again for your assistance.

Yours sincerely,

Stuart McCarthy

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

Dear Stuart



Thank you for your FOI request which was received by the Therapeutic Goods Administration on 4 May 2016.



I am writing to inform you that it appears that the scope of your request may be too voluminous.



In order to reduce your scope, could you please advise of the specific information that you seek, such as:

specific documents



For example, you may wish to consider submitting the following scope:



“I hereby request the TGA to provide documents relating to any approvals for the ADF or Department of Defence to administer tafenoquine to Australian personnel during 1999-2001, specifically:



a. Requests from ADF or Defence officials for TGA approval to use tafenoquine.



b. Minutes of meetings, records of conversations, or other correspondence between TGA and Defence officials, relating to such requests.



c. Internal TGA correspondence relating to proposed Defence use of tafenoquine, including minutes of meetings, records of conversation or emails.



d. Correspondence between TGA officials and GlaxoSmithKline relating to the proposed use of tafenoquine.



e. Written approvals by the TGA for Defence use of tafenoquine.



f. Reports from Defence officials to the TGA relating to adverse events experienced by ADF personnel administered tafenoquine during this period.”



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



Please don't hesitate to contact me if you have any questions or if you would like to discuss this.



Kind regards



Freedom of Information

Reporting and Collaborative Services Section

Regulatory Engagement and Planning Branch

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



[2]cid:image004.png@01D10B4F.695253A0







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