Dear Mr Hamblin

 

I refer to your FOI request of 28 August 2015 to the Department of Health
(as below).

 

Section 15 of the FOI Act requires that a request for documents meets
certain requirements. Your request, in its current form, does not
constitute a valid request. Please note that the Act provides for access
to documents and not to 'information'. In order for your request to be
processed under the provisions of the FOI Act you must provide us with
further information to enable us to identify the document or documents you
are seeking.

 

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

 

“All adverse event reports received by the TGA associated with the use of
Champix, including where death has occurred.”

 

Please note that this scope is a sample only. 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.

 

Additionally, it appears that the information you require is publicly
available via the Database of Adverse Event Notifications (DAEN) on the
TGA website, which provides a list of all adverse event reports that have
been notified to the TGA. Please see the following link for your
information:
[1]https://www.tga.gov.au/database-adverse-...

 

Please do not hesitate to contact me if you would like to discuss this
further.

 

Kind regards

Liz

 

 

Freedom of Information
Liz Santolin 02 6232 8664
Emily May 02 6232 8792

Karen Bedford 02 6232 8772

Committees, Planning and Stakeholder Support Section

Regulatory Engagement, Education and Planning Branch

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

[3]cid:image003.gif@01CFA69C.488B9550

 

 

 

 

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