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Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2022 - Jun 2023

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The Department of Health, of which the TGA is a part, is required by section 11C of the Freedom of Information Act 1982 (the FOI Act) to disclose access decisions through a disclosure log on its website. The disclosure log provides access to information which has been released in response to an FOI request. However, personal information and information about the business, commercial, financial or professional affairs of a person is deleted from the documents if publication of that information would be unreasonable.

The documents released by the TGA under section 11C of the FOI Act have been made available on this site in Portable Document Format (PDF). They are available for downloading and printing. If you require access to the documents in an alternative format please contact the FOI Coordinator by emailing tga.foi@health.gov.au or calling the TGA on 1800 020 653 or 02 6289 4630.

For documents released under the FOI Act by the Department of Health, please visit the Department of Health's FOI disclosure log.

Date of releaseFOI numberDocuments
22 June 2023FOI 4441

Submissions/applications, outcomes and notification data under the Special Access Scheme and Authorised Prescriber scheme for off-label uses of the drugs Leuprorelin and Goserelin for the past five years

14 June 2023FOI 4288

Documents relating to the TGA consultation on proposed vaping reforms from 30 November 2022 to 13 March 2023

8 June 2023FOI 4289

Documents relating to the TGA consultation on proposed vaping reforms

2 June 2023FOI 4235

Correspondence between TGA & Mind Medicine Australia

31 May 2023FOI 4352

Evaluation of Medicinal Cannabis SAS and AP pathways

22 May 2023FOI 4251

COVID-19: Causality assessment outcomes for deaths assessed by TGA as likely to be linked to COVID-19 vaccination

15 May 2023FOI 4359

Documents relating to the Proposed amendments to the Poisons Standards - ACCS#21

9 May 2023FOI 4302

​Adverse Event Following Immunisation (AEFI) causality assessment template (current)

8 May 2023FOI 4313

COVID-19: Causality assessment of DAEN case 734187

8 May 2023FOI 4240

​Documentation of TGA efforts to follow up cases 719838 and 724023

2 May 2023FOI 4355

Data relating to rejections for medicinal cannabis products under SAS Category B

1 May 2023FOI 4215

​Information related to final rulings of adverse event reports 724023 and 719838

28 April 2023FOI 4217

​COVID-19: Adverse event reports for deaths in children under 18 years following immunisation

27 April 2023FOI 4334

COVID-19: Table of vaccine related deaths

14 April 2023FOI 4297

Medicinal Cannabis - Special Access Scheme and Authorised Prescriber data

30 March 2023FOI 4205

Data from December 2021 to December 2022 of covid vaccinated deaths in Australia included in the adverse event reports submitted to the TGA

27 March 2023FOI 4281

Product Information for TRUST SINUS & NASAL DECONGESTANT and TRUST FLUDOL DAY & NIGHT

24 March 2023FOI 4231

​Documents containing the decision type and reason as recorded in the AEMS database for the removal of 464 entries in the Database of Adverse Event Notifications (DAEN).

22 March 2023FOI 4139

Communications between Edgewell Personal Care Australia Pty Ltd and the Therapeutic Goods Administration concerning benzene in Banana Boat brand sunscreen products.

21 March 2023FOI 4257

Medicinal Cannabis data taken from six-monthly reports from product sponsors between 1/7/2022 and 31/12/2022

10 March 2023FOI 4174

​Documents relating to lumbar total disc replacement prosthesis LP ESP, sponsored by Orthotec Pty Ltd.

10 March 2023FOI 4149

​Documents used in assessing compliance for therapeutic goods listed under 26A of the TGA Act.

9 March 2023FOI 4226

ACMS minutes on Scheduling of Psilocybin & MDMA.

7 March 2023FOI 4199

​SAS B approvals, rejections and pending applications for schedule 9 substances (excluding Psilocybin & MDMA) from January 2018 - January 2023.

6 March 2023FOI 4158

Correspondence between TGA and NATA regarding face mask testing

16 February 2023FOI 4093

Meeting Minutes of the Advisory Committee on Vaccines regarding Pfizer Covid-19 vaccines.

13 February 2023FOI 4155

Archived ARTG summaries for multiple cancelled complementary/over the counter medicine products.

7 February 2023FOI 4119

Products containing Tofacitinib as an active pharmaceutical ingredient prior to 5 February 2015.

2 February 2023FOI 4097

Lifeblood submission and associated considerations relating to decision to reduce the deferral period for blood donors from 12 months to 3 months.

19 January 2023FOI 4090

Documents relating to the Wirion filter device (ARTG 280883) and the Emboli capture guidewire device (ARTG 372170).

19 January 2023FOI 4073

Notification and subsequent investigation conducted as part of the TGA review of reports of deaths in nursing home residents in Norway after Pfizer BioNTech vaccination.

9 January 2023FOI 4029

COVID Pharmacovigilance activities including ACV and VSIG minutes.

4 January 2023FOI 3978

Laboratory testing as part of the batch release protocol of three CSL Behring Pty Ltd immunoglobulin injection products

22 December 2022FOI 4105

SAS Category B applications and approvals submitted to the TGA between Jan 2018 and June 2022 for Diflunisal to treat Transthyretin Amyloidosis

22 December 2022FOI 3965

Sinus-Venous stent records.

22 December 2022FOI 4030

Request for last publicly available Australian PI, CMI and public ARTG summaries for MEXITIL mexiletine hydrochloride capsules.

21 December 2022FOI 4077

Batch numbers of COVID-19 vaccines of reported deaths.

15 December 2022FOI 4078

Medicinal cannabis Special Access Scheme and Authorised Prescriber statistics - 1 January to 30 June 2022

9 December 2022FOI 4104

Data relating to Special Access Scheme Category B applications for Psilocybin and MDMA from January 2018.

29 November 2022FOI 4032

Proportionality Reporting Ratio analyses for the COVID-19 vaccines to 22 October 2022

18 November 2022FOI 4020

Applications under SAS Category B and Authorised prescriber data for medicinal cannabis products for the period 1 February 2016 to 30 September 2022.

18 November 2022FOI 3909

Summary of medicine defect reports for medicinal cannabis products for the period 1 January 2018 to 30 July 2022

4 November 2022FOI 3988

Product Information documents for Quilonum SR (Lithium Carbonate) tablets

18 October 2022FOI 3981

Data from adverse event reports for the period 25 May 2020 to 15 September 2022, for medicines containing cannabinoids

17 October 2022FOI 3999

SAS Category C notifications received by TGA for Indigo Carmine Injection (July 2017 – June 2022)

28 September 2022FOI 3898

Request for Investigator's Brochure BNT162/PF-07302048

19 September 2022FOI 3910

Request for data in relation to medicinal cannabis advertising compliance complaints

5 September 2022FOI 3890

Documents relating to testing of Rabipur Vaccine

2 September 2022FOI 3924

Special Access Scheme (SAS) data specific to medicinal cannabis during the period 1/01/2022 to 10/08/2022, and Authorised Prescriber (AP) data specific to medicinal cannabis for the period 1/1/2016 to 31/7/2022

25 August 2022FOI 3784

Documents relating to the Section 7 declaration regarding goods containing folate substances.

19 August 2022FOI 3889

Number of SAS requests for bedaquiline tablets from January 2020 to January 2022.

2 August 2022FOI 3828

Hepatitis B vaccines and Pharmacovigilance reports

1 August 2022FOI 3845

The age of deceased and case number for all reported adverse events resulting in death for events reported against any of the TGA approved COVID-19 vaccines to 28 June 2022.

22 July 2022FOI 3727

TGA Case Assessment summaries in relation to specific case numbers on the Database of Adverse Event Notifications (DAEN), and data on the numbers of adverse events reported to Pfizer.

13 July 2022FOI 3759

Request for the full quantitative composition of the ingredients listed in the Product Information for Pulmicort Respules.

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