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Foifoi Mcgee
Email: xxxxxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxx.xxx.xx
Dear Foifoi Mcgee
FREEDOM OF INFORMATION REQUEST FOI 26-2188
Revision
1. I refer to your request dated 16 September 2025 under the
Freedom of Information Act 1982 (the
FOI Act) and to our letter dated 16 October 2025, in which I advised that the work involved in
processing your request in its current form would substantially and unreasonably divert the
resources of the TGA from its other operations due to its broad scope - a ‘practical refusal reason’
(section 24AA).
2. In that letter, I outlined the reasons for my decision, including setting out the large quantity of
material that had been identified during preliminary searches:
The TGA has now undertaken a preliminary search of products that potential y use a manufacturing
site in Israel. More specifically, the TGA conducted an analysis on the ARTG dataset which indicated
that there are over 2,000 product categories that may have an association with a manufacturer site
in Israel. Additionally, the TGA has identified over 400 third parties that would require consultation
to confirm whether these sites are used for any step in the manufacturing process.
3. Further to my letter of 16 October 2025, these numbers have since been revised, principally as
the numbers referred to in my letter of 16 October 2025 inadvertently included medical devices
and export only products. I confirm that we have identified 920 products, 50 sponsors and 20
manufacturers.
4. These numbers remain significantly high, and as such do not change the approach outlined in my
letter of 16 October 2025, for which your response by 30 October 2025 is requested, as outlined
in paragraphs 21-28 of that letter.
Authorised and electronically signed by
Delegated FOI Decision Maker
Freedom of Information Team
Therapeutic Goods Administration
22 October 2025
PO Box 100 Woden ACT 2606 ABN 40 939 406 804
Phone: 1800 020 653 or 02 6289 4124 Fax: 02 6203 1605
Email: xxxx@xxx.xxx.xx
https://www.tga.gov.au
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Attachment A
Freedom of Information Act 1982
24 Powers to refuse request—diversion of resources etc.
(1) If an agency or Minister is satisfied, when dealing with a request for a document, that a practical
refusal reason exists in relation to the request (see section 24AA), the agency or Minister:
(a) must undertake a request consultation process (see section 24AB); and
(b) if, after the request consultation process, the agency or Minister is satisfied that the
practical refusal reason still exists—the agency or Minister may refuse to give access to the
document in accordance with the request.
(2) For the purposes of this section, the agency or Minister may treat 2 or more requests as a single
request if the agency or Minister is satisfied that:
(a) the requests relate to the same document or documents; or
(b) the requests relate to documents, the subject matter of which is substantially the same.
24AA When does a practical refusal reason exist?
(1) For the purposes of section 24, a practical refusal reason exists in relation to a request for a
document if either (or both) of the following applies:
(a) the work involved in processing the request:
(i) in the case of an agency—would substantially and unreasonably divert the resources of the
agency from its other operations; or
(ii) in the case of a Minister—would substantially and unreasonably interfere with the
performance of the Minister’s functions;
(b) the request does not satisfy the requirement in paragraph 15(2)(b) (identification of
documents).
(2) Subject to subsection (3), but without limiting the matters to which the agency or Minister may
have regard, in deciding whether a practical refusal reason exists, the agency or Minister must have
regard to the resources that would have to be used for the following:
(a) identifying, locating or collating the documents within the filing system of the agency, or
the office of the Minister;
(b) deciding whether to grant, refuse or defer access to a document to which the request
relates, or to grant access to an edited copy of such a document, including resources that would
have to be used for:
(i) examining the document; or
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(ii) consulting with any person or body in relation to the request;
(c) making a copy, or an edited copy, of the document;
(d) notifying any interim or final decision on the request.
(3) In deciding whether a practical refusal reason exists, an agency or Minister must not have regard
to:
(a) any reasons that the applicant gives for requesting access; or
(b) the agency’s or Minister’s belief as to what the applicant’s reasons are for requesting
access; or
(c) any maximum amount, specified in the regulations, payable as a charge for processing a
request of that kind.
24AB What is a request consultation process?
Scope
(1) This section sets out what is a
request consultation process for the purposes of section 24.
Requirement to notify
(2) The agency or Minister must give the applicant a written notice stating the following:
(a) an intention to refuse access to a document in accordance with a request;
(b) the practical refusal reason;
(c) the name of an officer of the agency or member of staff of the Minister (the
contact
person) with whom the applicant may consult during a period;
(d) details of how the applicant may contact the contact person;
(e) that the period (the
consultation period) during which the applicant may consult with
the contact person is 14 days after the day the applicant is given the notice.
Assistance to revise request
(3) If the applicant contacts the contact person during the consultation period in accordance with
the notice, the agency or Minister must take reasonable steps to assist the applicant to revise the
request so that the practical refusal reason no longer exists.
(4) For the purposes of subsection (3),
reasonable steps includes the following:
(a) giving the applicant a reasonable opportunity to consult with the contact person;
(b) providing the applicant with any information that would assist the applicant to revise the
request.
Extension of consultation period
(5) The contact person may, with the applicant’s agreement, extend the consultation period by
written notice to the applicant.
Outcome of request consultation process
(6) The applicant must, before the end of the consultation period, do one of the following, by written
notice to the agency or Minister:
(a) withdraw the request;
(b) make a revised request;
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(c) indicate that the applicant does not wish to revise the request.
(7) The request is taken to have been withdrawn under subsection (6) at the end of the consultation
period if:
(a) the applicant does not consult the contact person during the consultation period in
accordance with the notice; or
(b) the applicant does not do one of the things mentioned in subsection (6) before the end of
the consultation period.
Consultation period to be disregarded in calculating processing period
(8) The period starting on the day an applicant is given a notice under subsection (2) and ending on
the day the applicant does one of the things mentioned in paragraph (6)(b) or (c) is to be disregarded
in working out the 30 day period mentioned in paragraph 15(5)(b).
Note: Paragraph 15(5)(b) requires that an agency or Minister take all reasonable steps to notify an
applicant of a decision on the applicant’s request within 30 days after the request is made.
No more than one request consultation process required
(9) To avoid doubt, this section only obliges the agency or Minister to undertake a request
consultation process once for any particular request.
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