s22
Email: s22
Dear s22
FREEDOM OF INFORMATION REQUEST FOI 5255
Estimate of Charges
1. I refer to your request dated 8 July 2024 under the
Freedom of Information Act 1982
(the FOI Act) and subsequent correspondence between you and the TGA in which the
scope of your request was clarified as being for access to the following documents:
‘. .I seek access to copies of data tables relating to Authorised Prescriber and Special
Access Scheme Category A and B pathways specific to medicinal cannabis products
during the period 01/01/16 to 01/06/24. As wel as adverse event reports information,
equivalent to the information included in the DAEN – medicines, for adverse event
reports where a medicine containing cannabinoids is the suspect or interacting medicine,
during the period 01/01/16 to 01/06/2024.
The specific data parameters col ected under the SAS scheme I am requesting are:
Submission, Received Date, Application Date, Form Type, Product Type, Previous SAS
Number, Decision, Decision date, Duration Of Supply, Patient DOB, Patient Gender,
Product profile, Product Presentation, Indication, Dosage Regimen, Strength/Dimensions,
Strength Unit, Active Ingredient, SUSMP Schedule, Route of Administration, Cannabis
State Application Required, Active Ingredient Category, Practitioner Type, Prescriber
Specialty, Consulting Location
The specific data parameters col ected under the AP scheme I am requesting are:
Submission, Received Date, Application Date, Withdrawn Date, Expiry Date, Decision
date, Decision, Product Type, Duration Of Supply, Medicine with an established history of
use, Unapproved Product, Product Presentation, Primary Indication, Endorsing Body,
HREC Endorsing indications / reasons, Primary Location
(State or Territory),
Prescriber Specialty, Reporting Period, Total number of patients, Number of New
Patients
I am aware that:
Regarding SAS and AP data: The TGA changed from trade name based medicinal
cannabis submissions to category-based submissions on 22/11/2021. Data provided from
1/1/2016 to 21/11/2021 wil be based on the schedule of the product, rather than
individual trade names. Data from 22/11/2021 to 1/6/2024 wil be based on category-
based submissions.
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
Regarding DAEN data: The fol owing Adverse Event data can be provided and is
consistent with information within the DAEN and previously processed FOI requests –
Case number, Report Entry date, Gender, Age, Medicines reported as being taken and
medDRA reaction terms. The date range would be limited to that not previously released
under other FOIs.’
2. 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.
3. 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.
4. 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 27.5 hours @ $15.00 per hour
$412.50
time spent locating relevant files and
collating relevant documents
contained on those files)
Decision making time (including
5.45 hours @ $20.00 per hour
$9.03
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
$421.53
Deposit required
$105.38
5. 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 $421.53, I have decided you are required to pay a deposit of 25 percent, being
$105.38. Details of how to make a payment are outlined below.
6. 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.
7. 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.
Page 2 of 4
8. 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
9. 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.
10. 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.
11. 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.
12. 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
13. 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).
14. 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 5255 in your payment.
Page 3 of 4
15. 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.
16.
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
17. 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.
18. 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.
19. If you require clarification of any of the matters discussed in this letter, please contact
the FOI Team on (02) 6289 4630.
Yours sincerely
Electronical y authorised and signed by
s22
s22
Business Improvement and Compliance Section
International Regulatory Branch
Therapeutic Goods Administration
31 July 2024
Page 4 of 4
