s22
Email: s22
Dear s22
FREEDOM OF INFORMATION REQUEST FOI 5246
Estimate of Charges
1. I refer to your request dated 3 July 2024 under the
Freedom of Information Act 1982
(the FOI Act) for access to the following documents:
‘A list of overseas-registered semaglutide products approved for temporary use while the
Ozempic registered in Australia is unavailable, including product name, manufacturer,
distributor, country where overseas registration was obtained, and other available
details about the product
A copy of the registration certificate oversees for each instance of this product’s import
since approved for temporary use
A copy of export and import certificates for each instance of this product’s import since
approved for temporary use
A copy of the air waybill for each instance of the products’ import since approved for
temporary use
A copy of the packaging manifest for each instance of the products’ import since
approved for temporary use.’
The timeframe for your request is from 1 January 2019 to 3 July 2024.
Background
2. On 3 July 2024, the TGA received a request from you under the FOI Act.
3. On 9 July 2024, you advised that personal information of third parties is excluded from
the scope of your request.
4. On 22 July 2024, the TGA wrote to you to advise that the Medicines Shortages Section
has been able to compile a table for the purposes of fulfilling part 1 your request,
adding that much of the information you have requested in relation to this point is
available on the TGA’s Section 19A database.
5. On this date, you were also advised that ‘…
the last three columns of the spreadsheet
being ‘Product Images’, ‘Dear Healthcare Professional Letter’ and ‘Summary of Product
Characteristics’ contain links (only) to approximately 70 documents containing in excess
of 900 pages. .’ and your consideration was sought of
‘omitting these documents from
the scope of your request, however noting that you may at a later date choose to seek
access to these individual documents. If you [were] amenable to this, it [was] proposed
that the table be provided to you in response to your request, FOI 5246’ and ‘
In relation
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
to the other points of your scope, [the line area] advised that the Australian Border Force
would be best placed to assist you...’
6. You responded of even date, advising
‘Ok, that is fine, thank you.' 7. Under the
Freedom of Information (Charges) Regulations 2019 (the Regulations) a
charge can be imposed in respect of a request for access to documents under the FOI
Act. The charge is for the search and retrieval of documents, decision making and
provision of access.
8. I am an authorised decision maker under section 23 of the FOI Act and I have decided
that you are liable to pay a charge in respect of the processing of your request for
access.
9. A search and retrieval of documents relevant to your request has been undertaken and
a preliminary estimate of charges has been calculated. It is set out in the table below.
Search and retrieval time (including 5 hours @ $15.00 per hour
$75.00
time spent locating relevant files and
collating relevant documents
contained on those files)
Decision making time (including
12.24 hours @ $20.00 per hour
$144.88
time spent examining the
L ess first 5 hours which are free
documents, considering exemptions,
undertaking consultation, writing
the decision and preparing any
documents for release)
TOTAL
$219.88
Deposit required
$54.97
10. Under the Regulations where a charge is imposed and exceeds $100.00, a deposit of 25
percent may be sought. Based on the preliminary estimate of charges for your request
which is $219.88, I have decided you are required to pay a deposit of 25 percent, being
$54.97.
Details of how to make a payment are outlined below.
11. Under subsection 29(1) of the FOI Act, I am required to notify you that you have 30
calendar days from receipt of this notice to do one of the following:
• pay the charge, being the deposit outlined above, and notify the FOI Team via the
email below; or
• notify the TGA that you wish to contend that:
- the charge has been wrongly assessed, giving reasons; or
- the charge should be reduced or not imposed (for instance, where payment of
the charge would cause you financial hardship or where you believe access to
documents is in the general public interest), with reasons; or
• notify the TGA that you withdraw your request.
12. Please note, should you seek a reduction or waiver of charges on the grounds of
financial hardship it would assist the decision maker considering your request if you
provide suitable evidence of financial hardship (for example, by providing evidence of
receipt of a pension or income support payment; or provide evidence of income, debts
or assets). This is consistent with the FOI Guidelines www.oaic.gov.au/freedom-of-
information/foi-guidelines/part-4-charges-for-providing-access. Evidence should be
provided at the time of seeking waiver or reduction.
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13. If you fail to notify the TGA within 30 days about what you propose to do, the FOI Act
provides under subsection 29(2) that you are taken to have withdrawn your request.
Timeframes
14. The time limit for processing your request is suspended, in accordance with section 31
of the FOI Act, from the date you receive this notice and resumes on the day you pay
the charge or deposit (including any reduced charge or deposit), or the day on which
the TGA makes a decision not to impose a charge.
15. Once your FOI request has been processed, the TGA will determine the actual charge
you must pay before the documents can be provided to you. The final charge for
processing your request may be different from the estimate quoted in this letter. If I
decide to grant full access to all the documents within the scope of your request, you
must pay the actual charges for the time and disbursements involved in processing
your request ascertained in accordance with the table set out above (which may be
greater or less than the estimate). However, if you are only granted partial access to
the documents, you will only be required to pay whichever amount is the lesser of the
estimate quoted in this letter and the actual charges.
16. Please note that the decision maker can make a decision to charge for search and
retrieval that the TGA has already undertaken for the purposes of your request in its
current form, but it may be possible to reduce the decision making charges that might
be incurred by the TGA in the future if you refine the scope of your request, for
example, by limiting the date range of documents sought or excluding a particular
category of documents.
17. If you agree to pay the charge, you are accepting liability for settlement of the debt
upon completion of processing the FOI request. Once your FOI request has been
processed, the outstanding amount of the charge becomes a debt to the
Commonwealth. The TGA is obliged to pursue recovery of the debt in accordance with
the
Public Governance, Performance and Accountability Act 2013.
Payment
18. Payments for FOI requests must be made online via the TGA’s Online Payment
Portal (www.tga.gov.au/how-we-regulate/fees-and-payments/payment-
options/online-payment-portal).
19. To make an FOI payment, you will be required to enter specific information as outlined
below. From the Online Payment Portal site, click on the option titled ‘
Online
payment portal’ to display the payment portal page. From the payment portal page,
enter the following information:
• ‘
Biller Code’, click on the drop-down arrow to select option ’
11 – Freedom of
Information (FOI)’.
• ‘
Client Identification Number’, enter ‘
CO-9001’.
• ‘
Reference Number’, enter your unique FOI identification number fol owed by
your first and last name (e.g. ‘
FOI-XXXX John Smith’).
• ‘
Email Address for Tax Receipt’, enter the email address you wish to receive a tax
receipt for your payment transaction. This email will contain a unique 11 digit
payment transaction number to quote if you have any queries. Please retain this
email for your records. A tax invoice will not be issued for this transaction.
• ‘
Amount (AUD)’, enter the amount of the payment being made.
• ‘
Select your payment option’, click on the relevant icon to proceed to the next
screen.
Please include reference to FOI 5246 in your payment.
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20. If you require assistance with making a payment, please contact the TGA Accounts
team on 1800 020 653 (option 5) or by email at xxxxxxxxxxx@xxxxxx.xxx.xx. Users
who are deaf or have a hearing or speech impairment can call through the National
Relay Service: TTY or computer with modem users: phone 1800 555 677 then ask for
1800 020 653. Speak and listen (speech to speech relay) users: phone 1800 555 727
then ask for 1800 020 653.
21.
IMPORTANT: Once payment has been made, please notify the FOI Team via the
following email address: xxxxxx@xxxxxx.xxx.xx. Failure to notify the FOI Team of
payment may result in delays to the processing of your FOI request.
Third Party Consultation
22. In the event your request relates to documents that include information about a
person or their business or professional affairs or about the business, commercial or
financial affairs of an organisation or undertaking, pursuant to section 27 and 27A of
the FOI Act the TGA will be required to provide that person or organisation the
opportunity to make submissions if it appears that they may wish to argue any
document is exempt from release.
23. The statutory time limit for processing an FOI request will be extended by 30 days
under subsection 15(6) of the FOI Act where a third party is to be consulted.
24. If you require clarification of any of the matters discussed in this letter, please contact
the FOI Team on (02) 6289 4630.
Yours sincerely
Authorised and electronically signed by
Elspeth Kay
Assistant Secretary
Pharmacovigilance Branch
Therapeutic Goods Administration
25 July 2024
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