Registration information and amendments to dosage of mefloquine ('Lariam')

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

The request was successful.

From: Jane Quinn

Delivered

Dear Therapeutic Goods Administration,

Please can you provide me with the original registration submission and approval documents, and then any subsequent documentation relating to approval or amendment of dosage for the antimalarial drug mefloquine (trade name 'Lariam').

Yours faithfully,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Quinn
 
I refer to your FOI request of 17 June 2017 to the Department of Health
(as below).
 
“Please can you provide me with the original registration submission and
approval documents, and then any subsequent documentation relating to
approval or amendment of dosage for the antimalarial drug mefloquine
(trade name 'Lariam').”
 
I would like to clarify the documents you are seeking in relation to the
“any subsequent documentation” part of your request.  There are various
documents that may have been provided to the TGA or created by the TGA
associated with an approval or amendment of dosage. If you are able to
specify the type of documents you are seeking, it may assist in expediting
the processing of your request.
 
For example, you may wish to consider submitting the following scope:
 
“Please can you provide me with the original registration submission and
approval documents, and then any subsequent approval letters relating to
approval or amendment of dosage for the antimalarial drug mefloquine
(trade name 'Lariam').”
 
Please note that this scope is an example only and that you may wish to
clarify the scope of your request in other ways.  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. 
 
Alternatively, I would greatly appreciate if you could provide us with
more information on the specific documents that you require.
 
Please don't hesitate to contact me should you have any further questions.
 
Kind regards
Jacki
 
Freedom of Information
(02) 6232 8612
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
 
 
 

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From: Jane Quinn

Delivered

Dear TGA FOI - Jacki,

Thank you for your prompt reply. I shall certainly go on your best advice and amend my request as follows:

Please can you provide me with the original registration submissions and approval documents related to the various dosing schedules for Mefloquine (trade name 'Lariam'), where dosing schedule reflects both the amount and / or frequency of the drug in question.

Please also provide any subsequent approval applications or letters relating to amendment of the aforementioned dosing schedules.

I hope this makes my request clearer.

Please let me know if there is any further information you require to process this request.

Yours sincerely,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Quinn

 

Thank you for your email received 21 June 2017 in relation to clarifying
the scope of your FOI request. I understand the revised scope to be as
follows:

 

“Please can you provide me with the original registration submissions and
approval documents related to the various dosing schedules for Mefloquine
(trade name 'Lariam'), where dosing schedule reflects both the amount and
/ or frequency of the drug in question.

 

Please also provide any subsequent approval applications or letters
relating to amendment of the aforementioned dosing schedules.”

 

Thank you for clarifying the second part of your request. In reference to
the first part of your request, can you please clarify the term
“submissions”. If you are seeking the data as well as the covering
paperwork, this could result in the request being too voluminous. If this
is the case, in order to reduce your scope could you please advise of the
specific information that you seek, such as:

·         The original submission and approval letter, or

·         A specific dosage approval letter, or

·         A date range.

 

Alternatively, I would greatly appreciate if you could provide us with
more information on the specific documents that you require in order to
process your FOI request. We look forward to your response by COB 26 June
2017.

 

Please don't hesitate to contact me should you have any further questions.

 

Kind regards,

Jacki

 

Freedom of Information
(02) 6232 8612

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 - Jacki,

Thank you for your letter.
To clarify, I wish to request documentation specifically related to registration or amendment of the dosing schedule for Mefloquine / Lariam.

This would include the full registration application but then only additional documents, or part thereof, relating to applications or approvals for changes to the dosing schedule.

I hope this helps limit the information required.

Yours sincerely,

Jane Quinn

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From: FOI
Therapeutic Goods Administration

Dear Ms 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 Officer

Ministerial, Parliamentary, Executive Support and Governance Branch
People, Capability and Communication 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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Dear Ms Quinn,

I refer to your request dated 17 June 2017 under the Freedom of
Information Act 1982 (FOI Act) which you have clarified as being for:
 
“Please can you provide me with the original registration submission and 
approval documents related to the various dosing schedules for the
antimalarial drug  Mefloquine (trade name 'Lariam'). Please also provide
any subsequent approval applications or letters  relating to amendment of
the aforementioned dosing schedules.”
 
As you may be aware, section 12(a) of the FOI Act relevantly provides that
a person is not entitled to a document, or a copy of a document, which is
under the Archives Act 1983 (Archives Act), within the open access period
within the meaning of that Act. The open access period currently applies
to documents created prior to 1 January 1994. Some of the documents that
you have requested may fall within the open access period, and will
therefore fall under the jurisdiction of the National Archives.

As a courtesy I am writing to you to inform you that the search and
retrieval conducted by the TGA with respect to your request will be
limited to documents currently in the TGA's custody and not excluded under
section 12(a) of the FOI Act.  Access to documents falling outside this
period (those older than 23 years) will need to be arranged under the
Archives Act through the National Archives. In particular please note that
as Mefloquine was registered on the Australian Register of Therapeutic
Goods on 27 January 1993 the original registration submission provided to
the TGA prior to that registration will not be considered as part of your
request as it falls within the open access period.   
 
If you wish to obtain access to earlier records, you will need to do so
under the Archives Act.  Even where some of the records you are seeking
may be in the physical possession of the TGA/DoH, it is still necessary to
apply for them under the Archives Act.  Archives will then retrieve any
relevant records from the TGA/DoH for the purpose of considering your
request for access to the records.
 
The following information may be useful to you in understanding when to
apply for documents/records under the FOI Act and when to apply under the
Archives Act:

* When to use the Freedom of Information, Archives and Privacy Acts –
Fact sheet 110
[1]http://www.naa.gov.au/collection/fact-sh...
* Access to records under the Archives Act – Fact sheet 10 -
[2]http://www.naa.gov.au/collection/fact-sh...

If you have any questions regarding the above please do not hesitate to
contact me.
 
Can you please advise whether you wish to proceed with your request as is,
withdraw your request or revise the scope of your request by 30 June 2017.

Regards,
Jacki
 
Freedom of Information
(02) 6232 8612
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]
 
 
 
 

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From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Quinn

 

Please find attached correspondence in relation to your FOI request.

 

Kind regards

Heather

 

Freedom of Information
(02) 6232 8612

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,

I have completed the credit card authorization and emailed to [email address].
I look forward to receiving the requested documents in the near future.

Yours sincerely,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Quinn
 
I am writing in relation to the scope of your FOI request 323-1617. Can
you please clarify if you are seeking 'personal information' (e.g., the
names and/or contact details of any individuals) 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.
 
If you are not seeking access to personal information, you can simply
reply: 'no personal information requested'.
 
We look forward to hearing from you by COB 7 August 2017.
 
Kind regards
 
Freedom of Information
(02) 6232 8612
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
 
 
 
 
 

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From: TGA FOI
Therapeutic Goods Administration


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Dear Ms Quinn
 
As we have not received a response from you, I am writing to follow up on
the below email.
 
Can you please respond by COB 10 August 2017.
 
Please note that if a response from you is not received by this time, the
TGA will assume no personal information is required.
 
Kind regards
Heather
 
Freedom of Information
(02) 6232 8612
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
 
 
 
 
 
_____________________________________________
From: TGA FOI
Sent: Tuesday, 1 August 2017 11:53 AM
To: 'Jane Quinn'
Cc: TGA FOI
Subject: FOI 323-1617 - Requesting personal information [SEC=UNCLASSIFIED]
 
 
Dear Ms Quinn
 
I am writing in relation to the scope of your FOI request 323-1617. Can
you please clarify if you are seeking 'personal information' (e.g., the
names and/or contact details of any individuals) 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.
 
If you are not seeking access to personal information, you can simply
reply: 'no personal information requested'.
 
We look forward to hearing from you by COB 7 August 2017.
 
Kind regards
 
Freedom of Information
(02) 6232 8612
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [2][email address]
 
<< OLE Object: Picture (Device Independent Bitmap) >>
 
 
 
 

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From: Jane Quinn

Delivered

Dear TGA FOI,

I do not require any personal information.

Yours sincerely,

Jane Quinn

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From: Jane Quinn

Delivered

Dear TGA FOI,

I have responded to this question through your portal on a number of ocassions. I am unclear as to why you have not received these responses.

I DO NOT require any personal information.

Yours sincerely,

Jane Quinn

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From: Jane Quinn

Delivered

Dear TGA FOI,

I have now responded to this request twice. Please can you confirm you have received this response.

Yours sincerely,

Jane Quinn

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From: Jane Quinn

Delivered

Dear TGA FOI,

I have responded to all information requests related to this FOI request and have paid the necessary fee. Please can you advise the date by which when I will receive the information requested? I am unclear why in have not already done so given that your fee was requested and paid in full.

Please can you respond by COB on 25th August 2017.

Yours sincerely,

Jane Quinn

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From: TGA FOI
Therapeutic Goods Administration

Dear Ms Quinn,

I confirm receipt of your correspondence of 8, 13 and 19 August 2017.

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.

As advised in our correspondence of 5 July 2017, the statutory timeframe for processing your request was extended by an additional 30 days under section 15(6) of the FOI Act to allow consultation to be undertaken with effected third parties.

Furthermore, the timeframe for processing your request was suspended between 5 July 2017 and 31 July 2017 pursuant to section 31 of the FOI Act, being the date you were notified of your liability to pay a charge and the date you paid the charge.

Currently, a decision on your request for access under the FOI Act is due on 11 September 2017.

Accordingly, a decision will be provided to you on or before this date.

I trust this information is of assistance.

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

Kind regards
Jodie

Freedom of Information
Jodie Russell 02 6232 8720
Karen Bedford 02 6232 8772
Heather Davidson 02 6232 8012

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: TGA FOI
Therapeutic Goods Administration


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Attachment D17 733654 FOI 323 1617 Notice of Decision.PDF.pdf
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Attachment ATTACHMENT B Decision letter.DOCX.docx
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Attachment ATTACHMENT C Review Rights.PDF.pdf
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Dear Ms Quinn,

 

Please find attached the Notice of Decision in relation to your Freedom of
Information request.

 

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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