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: https://www.tga.gov.au/database-adverse-event-notifications-daen

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: [email address]

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

From: Rod Hamblin [mailto:foi+[email address]]

Sent: Friday, 28 August 2015 1:01 PM

To: FOI

Subject: Freedom of Information request - Adverse effects to taking Champix [SEC=No Protective Marking]

Dear Advisory Committee on Prescription Medicines, I would like to know how many Adverse Effects to CHAMPIX by Pfizer have been reported & how many deaths have occurred due to taking Champix

Yours faithfully,

Rod Hamblin

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