Therapeutic Good Approved from Israel
Dear Therapeutic Goods Administration,
I would like documents, dated from 7 October 2023 until today, for all therapeutic goods approved that originate from Israel.
Yours faithfully,
Foifoi Mcgee
Dear Foifoi
FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT
I am writing to notify you that the Therapeutic Goods Administration
(Department of Health, Disability and Ageing) has received your request
for access to documents under the Freedom of Information Act 1982 (FOI
Act) as follows:
‘I would like documents, dated from 7 October 2023 until
today, for all therapeutic goods approved that originate from Israel.’
The timeframe for your request is from 7 October 2023 to 16 September
2025.
Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
from the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 16 October 2025, noting that where the last day for notifying a
decision falls due on a weekend or public holiday, the timeframe will
expire on the first business day following that day. Due to the statutory
processing time afforded under the FOI Act in which to provide you with a
decision in relation to your FOI request, we would be grateful if you
could please monitor your emails periodically for updates regarding your
request.
Where there is requirement to undertake consultation with affected third
parties, this timeframe is extended by a further 30 days. It may also be
extended in certain circumstances, including with your agreement or where
the Department applies to the Office of the Australian Information
Commissioner for an extension.
Unless you advise otherwise, draft and duplicate documents, Commonwealth
employee names and contact details of staff below Senior Executive Service
level, internal group email addresses and mobile telephone numbers of all
staff will be excluded from the scope of your request under section
22(1)(a)(ii) of the FOI Act.
Disclosure Log Publication:
The TGA is required under section 11C of the FOI Act to publish on its
website, or otherwise make available, documents released to an applicant
in response to an FOI request, unless exceptional circumstances apply. The
TGA publishes these documents on the FOI Disclosure Log at [1]FOI
Disclosure Log | Therapeutic Goods Administration. You can find more
information about the Disclosure Log at [2]OAIC FOI Guidelines |
Disclosure Logs.
Personal information:
I note from your request that you have not indicated whether you seek
access to the personal information of third parties (e.g. the names and
contact details of individuals, or any information that could reasonably
identify an individual). Seeking this information may require the
Department to consult with the identified individuals. This will increase
the time taken to process your request and the costs involved. As such, we
would be grateful if you would consider removing the personal information
of third parties from the scope of your request.
In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.
I would be grateful if you could respond to this email by COB tomorrow, 19
September 2025 so that we may continue processing your request.
If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [3][email address].
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health, Disability and Ageing
T: 02 6289 4630 | E: [4][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [5]www.tga.gov.au
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health, Disability and Ageing acknowledges the
Traditional Custodians of Australia and their continued connection to
land, sea and community. We pay our respects to all Elders past and
present.
OFFICIAL
OFFICIAL
Dear Foifoi Mcgee
Thank you for your FOI request which was received by the Therapeutic Goods
Administration (TGA) on 16 September 2025 seeking access to the following
under the Freedom of Information Act 1982 (Cth):
‘I would like documents, dated from 7 October 2023 until today [16
September 2025], for all therapeutic goods approved that originate from
Israel.’
I am writing to seek clarification on the scope of your request.
In its current form, the scope may be too voluminous for the TGA to
process on the basis that you are requesting all therapeutic goods, and
subsequently, this requires all regulatory areas of the TGA to conduct
searches. We would be grateful if you could revise the scope of your
request and specify the type of therapeutic good you are interested in:
‘I would like documents, dated from 7 October 2023 to 16 September 2025,
related to [Insert type of therapeutic good i.e. medicines (prescription
medicines or over the counter medicines etc) biologicals (human stem
cells, skin etc), medical devices (pacemakers, sterile bandages)] approved
that originate from Israel.”
To further revise the scope of your request, you may also wish to consider
narrowing the date range of your request to a 6-month period e.g. From 1
January 2025 to 30 June 2025.
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.
We would be grateful for your response by COB Monday 22 September 2025.
Please don't hesitate to contact the FOI team if you have any questions or
if you would like to discuss this matter further.
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health, Disability and Ageing
T: 02 6289 4630 | E: [1][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [2]www.tga.gov.au
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health, Disability and Ageing acknowledges the
Traditional Custodians of Australia and their continued connection to
land, sea and community. We pay our respects to all Elders past and
present.
OFFICIAL
OFFICIAL
Dear Foifoi Mcgee
I write to follow up on our email below.
Could you please provide a response by COB tomorrow, 25 September so that
we may continue to progress your request.
Kind regards
Karen
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health, Disability and Ageing
T: 02 6289 4630 | E: [1][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [2]www.tga.gov.au
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health, Disability and Ageing acknowledges the
Traditional Custodians of Australia and their continued connection to
land, sea and community. We pay our respects to all Elders past and
present.
From: TGA FOI <[email address]>
Sent: Friday, 19 September 2025 4:52 PM
To: '[FOI #13663 email]'
<[FOI #13663 email]>
Cc: TGA FOI <[email address]>
Subject: FOI 26-2188 - Mcgee - Request for scope clarification
[SEC=OFFICIAL]
OFFICIAL
Dear Foifoi Mcgee
Thank you for your FOI request which was received by the Therapeutic Goods
Administration (TGA) on 16 September 2025 seeking access to the following
under the Freedom of Information Act 1982 (Cth):
‘I would like documents, dated from 7 October 2023 until today [16
September 2025], for all therapeutic goods approved that originate from
Israel.’
I am writing to seek clarification on the scope of your request.
In its current form, the scope may be too voluminous for the TGA to
process on the basis that you are requesting all therapeutic goods, and
subsequently, this requires all regulatory areas of the TGA to conduct
searches. We would be grateful if you could revise the scope of your
request and specify the type of therapeutic good you are interested in:
‘I would like documents, dated from 7 October 2023 to 16 September 2025,
related to [Insert type of therapeutic good i.e. medicines (prescription
medicines or over the counter medicines etc) biologicals (human stem
cells, skin etc), medical devices (pacemakers, sterile bandages)] approved
that originate from Israel.”
To further revise the scope of your request, you may also wish to consider
narrowing the date range of your request to a 6-month period e.g. From 1
January 2025 to 30 June 2025.
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.
We would be grateful for your response by COB Monday 22 September 2025.
Please don't hesitate to contact the FOI team if you have any questions or
if you would like to discuss this matter further.
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health, Disability and Ageing
T: 02 6289 4630 | E: [3][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [4]www.tga.gov.au
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health, Disability and Ageing acknowledges the
Traditional Custodians of Australia and their continued connection to
land, sea and community. We pay our respects to all Elders past and
present.
OFFICIAL
OFFICIAL
OFFICIAL
Dear Foifoi Mcgee,
Thank you for your email dated 24 September 2025 and providing your scope
clarification.
The department’s internal line area will consider your revisions and if we
require any further consultation, we will be in touch.
If you have any questions with regards to the matters discussed in this
email, please contact the TGA FOI via details below.
Kind regards,
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health, Disability and Ageing
T: 02 6289 4630 | E: [1][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [2]www.tga.gov.au
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error, please notify the author immediately and delete all
copies of this transmission.
The Department of Health, Disability and Ageing acknowledges the
Traditional Custodians of Australia and their continued connection to
land, sea and community. We pay our respects to all Elders past and
present.
OFFICIAL
Dear Foifoi Mcgee,
Following from our previous email dated 25 September 2025, the TGA is
seeking to request further consultation with you in relation to the scope
of your request.
The TGA notes that you have narrowed the scope to medicines approved
originating from Israel; however, we advise that it currently remains
unclear.
Section 15(2)(b) of the FOI Act requires an applicant to provide
information concerning a document as is reasonably necessary to enable a
responsible officer of the agency to identify it. As you can appreciate,
requesting 'documents' would encompass any and all documents in relation
to approved medicines originating from Israel for the requested timeframe.
Revised scope
The TGA proposes the following ways to assist in the revising of the scope
of your request to assist in processing it:
o Limiting a singular subject matter i.e. prescription medicines or
complementary medicines or biologicals.
o Identifying a specific document or specifying the information that you
wish to access.
Additionally, if you have any further contextual information that you
would like to provide the TGA to narrow the scope of your request, we
would appreciate the opportunity to work with you.
Publicly available information
We would like to direct you to the public Australian Register of
Therapeutic Goods (ARTG) (which you can access [1]here) where you are able
to search for the sponsor of each product. Please note that all products
on the ARTG are required to have an Australian presence so you will need
to contact the companies listed directly to ascertain their connection to
countries involved in the manufacture of the goods.
Next steps – response requested 29 September 2025
The TGA is seeking your agreement to pursue one of the following:
1. refining the scope of your request further; or
2. given the publicly available information within the ARTG in relation
to medicines approved originating from Israel, whether you choose to
withdraw your request.
We look forward to hearing from you and if you have any questions
regarding any of the matters discussed in this email, please do not
hesitate to contact the TGA’s FOI section at [2][email address].
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health, Disability and Ageing
T: 02 6289 4630 | E: [3][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [4]www.tga.gov.au
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health, Disability and Ageing acknowledges the
Traditional Custodians of Australia and their continued connection to
land, sea and community. We pay our respects to all Elders past and
present.
From: TGA FOI <[email address]>
Sent: Thursday, 25 September 2025 11:55 AM
To: Foifoi Mcgee <[FOI #13663 email]>
Cc: TGA FOI <[email address]>
Subject: RE: FOI 26-2188 - Mcgee - Request for scope clarification
[SEC=OFFICIAL]
OFFICIAL
Dear Foifoi Mcgee,
Thank you for your email dated 24 September 2025 and providing your scope
clarification.
The department’s internal line area will consider your revisions and if we
require any further consultation, we will be in touch.
If you have any questions with regards to the matters discussed in this
email, please contact the TGA FOI via details below.
Kind regards,
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health, Disability and Ageing
T: 02 6289 4630 | E: [5][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [6]www.tga.gov.au
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error, please notify the author immediately and delete all
copies of this transmission.
The Department of Health, Disability and Ageing acknowledges the
Traditional Custodians of Australia and their continued connection to
land, sea and community. We pay our respects to all Elders past and
present.
OFFICIAL