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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 release | FOI number | Documents |
|---|---|---|
| 23 June 2022 | FOI 3785 | 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. Please note the document has been redacted to remove identifying information about cases, and information not requested by the applicant. |
| 10 June 2022 | FOI 3732 | Documents relating to consultation for the streamlined process for medicinal cannabis applications |
| 3 June 2022 | FOI 3659 | Post approval commitments by sponsor for Comirnaty in relation to batch analysis for drug product batches manufactured at Pfizer. 1 document released in full. 5 documents released in part, with redactions applied in accordance with section 47 and 47F of the FOI Act. |
| 22 April 2022 | FOI 3653 | Special Access Scheme/Authorised Prescribers of medicinal cannabis products. |
| 6 April 2022 | FOI 3581 | Documents in relation to Infants’ Friend |
| 28 March 2022 | FOI 3491 | Gardasil and Gardasil 9 Vaccination Reporting Cards (VRC) which are provided to participants during the clinical trials. |
| 25 March 2022 | FOI 3545 | COVID-19: Vaccine adverse event reporting data |
| 9 March 2022 | FOI 3471 | TGA laboratory analysis documentation of the following batches of Comirnaty vaccine: FL5333, FK8917, FH3221, FL3560, FE3430. 57 documents released in part, with redactions applied under section 22 and 47.
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| 25 February 2022 | FOI 3390 | TGA's batch release assessment for the batch FL7649 of Comirnaty COVID-19 vaccine. 11 documents released to the applicant with redactions under section 22 and 47 of the FOI Act.
|
| 25 February 2022 | FOI 3452 | Documents relating to the TGA's assessment of DAEN case number #647663, and de-identified medical registration details of TGA staff members who assessed the case. |
| 18 February 2022 | FOI 3426 | Request for data pertaining to SAS applications for biological products |
| 11 February 2022 | FOI 3586 | The age of deceased for all reported adverse events resulting in death for events reported against any of the TGA approved COVID-19 vaccines. Please note the document has been redacted to remove identifying information about cases, and information not requested by the applicant. |
| 10 February 2022 | FOI 3519 | Special Access Scheme/Authorised Prescriber applications for Glycopyrronium bromide tablets. |
| 10 February 2022 | FOI 3484 | Hepatitis B vaccine pharmacovigilance |
| 4 February 2022 | FOI 3520 | Number of serious adverse events reported following covid-19 vaccine injection, and number of serious adverse events reported in persons under the age of 18, correct up until 17 December 2021 |
| 28 January 2022 | FOI 3380 | Correspondence between the TGA and MP George Christensen, Senator Gerard Rennick and/or Senator Pauline Hanson |
| 21 January 2022 | FOI 3539 | Position descriptions of HPRG Executive |
| 10 January 2022 | FOI 3459 | A "breakdown summary table of all COVID-19 vaccines adverse effects notifications in a state and territory breakdown format, namely the
From 22 February 2021 to 5 December 2021. Document 1 - number of adverse event reports where death was a reported outcome by state and territory to 5 Dec 2021. Note: Since the beginning of the vaccine rollout to 5 December 2021, over 39.6 million doses of COVID-19 vaccines had been given. The TGA has identified 11 reports of death that were linked to vaccination from 702 reports received and reviewed up to 5 December 2021. Document 2 - number of adverse event reports by state and territory to 5 Dec 2021 |
| 8 January 2022 | FOI 3508 | Number of Adverse Event Reports held in the AEMS as at 12 August 2021 and 21 December 2021 |
| 6 January 2022 | FOI 3089 | TGA investigation into the utilisation of niPGT-A
|
| 23 December 2021 | FOI 3085 | Documents relating to the Essure contraceptive device |
| 29 November 2021 | FOI 3093 | Scientific evaluation of Pfizer COVID-19 vaccine. |
| 24 November 2021 | FOI 3061 | Documents in relation to ACMS and the restrictions on the prescribing of oral Ivermectin. |
| 23 November 2021 | FOI 3050 | Full register entry and Product Information for Isuprel 1:5000 1mg/5 mL injection ARTG 198888 and Isuprel 1:5000 isoprenaline hydrochloride 200 microgram/1 mL injection ampoule ARTG 198887 |
| 20 October 2021 | FOI 2892 | SAS approvals for biological products |
| 13 October 2021 | FOI 3025 | SAS Category B approvals between January 2020 to August 2021 and applications submitted to the TGA for Alloderm and AlloMax, and the consulting location of the submitting health care practitioner, where provided. |
| 14 September 2021 | FOI 2494 | Documents relating to the evaluation of the AstraZeneca COVID-19 vaccine |
| 3 September 2021 | FOI 2503 | SAS applications/notifications for Trientine tablets |
| 26 August 2021 | FOI 2377 | Documents relating to the Allergan textured products |
| 15 July 2021 | FOI 2389 | Documents relating to the evaluation of the Pfizer COVID-19 vaccine |
| 8 July 2021 | FOI 2291 | Minutes of pharmacovigilance (PV) committees and reports of PV investigations, which detail the investigation outcome, including associated PSUR assessment reports, related to the Gardasil vaccine, from 2008-2012.
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| 5 July 2021 | FOI 2419 | Documents relating to SAS medicinal cannabis applications |
| 1 Jul 2020 to 30 Jun 2021 | Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2020 to Jun 2021 | |
| 1 Jul 2019 to 30 Jun 2020 | Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2019 to Jun 2020 | |
| 1 Jul 2018 to 30 Jun 2019 | Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2018 to Jun 2019 | |
| 1 Jul 2017 to 30 Jun 2018 | Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2017 to Jun 2018 | |
| 1 Jul 2016 to 30 Jun 2017 | Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2016 to Jun 2017 | |
| 1 Jul 2015 to 30 Jun 2016 | Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2015 to Jun 2016 | |
| 1 Jul 2014 to 30 Jun 2015 | Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2014 to Jun 2015 | |
| 1 Jul 2013 to 30 Jun 2014 | Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2013 to Jun 2014 | |
| 1 Jul 2012 to 30 Jun 2013 | Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2012 to Jun 2013 | |
| 1 Jul 2011 to 30 Jun 2012 | Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2011 to Jun 2012 | |