We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
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 |
|---|---|---|
| 26 June 2024 | FOI 5053 | Correspondence and documents regarding Vyvanse shortage |
| 24 June 2024 | FOI 5085 | Medicines (Onset Time) data for COVID-19 vaccine adverse event reports |
| 24 June 2024 | FOI 5083 | Notices regarding Hydroxychloroquine such as Product Information and Consumer Medicine Information (CMI) leaflets for consumers and health professionals |
| 24 June 2024 | FOI 5104 | Application dates for Eliquis, Pradaxa and Xarelto |
| 14 June 2024 | FOI 4997 | Clinical trial notifications involving gene therapy products |
| 7 June 2024 | FOI 5073 | Correspondence between TGA and Minister Butler’s office regarding proposal to change Therapeutic Goods Regulations 1990 to remove all medicines containing GLP-1 receptor agonist analogues (GLP-1 RAs), including Semaglutide-like medicines, from the pharmacist extemporaneous compounding exemptions |
| 5 June 2024 | FOI 5064 | Common Technical Document (CTD) Modules 2.3.S.2 and 2.3.P.3 of DITROPAN oxybutynin hydrochloride |
| 3 June 2024 | FOI 5018 | Correspondence between the Minister for Health and Aged Care and Novo Nordisk regarding compounded Semaglutide |
| 28 May 2024 | FOI 4792 | Documents relating to the Trinity Biotech MarDx EU Lyme + VlsE IgG IgM Western Blot (ARTG 205544), including approval documents, recalls, complaints or device incident reports |
| 28 May 2024 | FOI 4983 | The schedule of documents prepared during searches conducted for FOI 4796 |
| 24 May 2024 | FOI 4879 | Prescribing requirements for MS-2 Step (Mifepristone and Misoprostol) |
| 16 May 2024 | FOI 4878 | Standard operating procedure for analysis of batch samples and full test results documentation for the analyses of COMIRNATY batches GE1643, GD6794 and GE8382 |
| 14 May 2024 | FOI 5074 | COVID-19 adverse events following immunisation in Adverse Event Management System (AEMS) and not in Database of Adverse Event Notification (DAEN) |
| 10 May 2024 | FOI 1781 | All documents and reports pertaining to the recall of the Neutrogena Visibly Clear Light Therapy Acne Mask and Activator |
| 7 May 2024 | FOI 4996 | Rapid Antigen Test (RAT) supply data and self-test reports for COVID-19 rapid antigen test kits under Australian Register of Therapeutic Goods (ARTG) number 374574 |
| 26 April 2024 | FOI 5011 | Authorised prescriber data for psilocybin and MDMA |
| 23 April 2024 | FOI 5007 | Authorised prescriber six-monthly report for psilocybin and MDMA |
| 22 April 2024 | FOI 5044 | A list of case numbers held within the Adverse Event Management System (AEMS) with death as a reported outcome for all medicines for date range 1 January 1971 to 31 March 2024 |
| 18 April 2024 | FOI 4622 | Conflict of interest declarations for committee members for the Australian Committee on Vaccines |
| 17 April 2024 | FOI 4989 | Authorised Prescriber and Special Access Scheme data for medicinal cannabis products, and adverse event reports containing cannabinoids for the period 1 January 2016 to 1 March 2024 |
| 16 April 2024 | FOI 4953 | Documents relating to the TGA’s decision to cancel and recall pholcodine-containing medicines |
| 16 April 2024 | FOI 4901 | Correspondence between the TGA and recipients of infringement notices for alleged unlawful advertising of medicinal cannabis products, including but not limited to advertising on websites and social media platforms |
| 11 April 2024 | FOI 4967 | Product Information (PI), Boxed Warnings, or Cancellation letters for all innovator Ciprofloxacin, Norfloxacin and Moxifloxacin antibiotics |
| 11 April 2024 | FOI 1036 | TGA assessment report and evaluation of the application to register PR-IRON+C (modified release tablet) |
| 10 April 2024 | FOI 4858 | Product Information (PI) and Consumer Medicine Information (CMI) for Melatonin by Link Medical Products |
| 10 April 2024 | FOI 4849 | Complaints, findings & investigations relating to Medacta J-Lock PEEK suture introducer |
| 8 April 2024 | FOI 5028 | The schedule of documents prepared during the search for documents relevant to FOI 4940 |
| 5 April 2024 | FOI 4910 | COVID-19 vaccines adverse event data for the period |
| 27 March 2024 | FOI 5000 | Special Access Scheme and Authorised Prescriber data for unregistered medicinal cannabis products for the period 1 July 2023 to 31 December 2023 |
| 23 February 2024 | FOI 4952 | Medication terms listed in the ‘Medicines reported as being taken’ column of the TGA Database of Adverse Event Notification that the TGA considers vaccines, with the exception of those considered to be vaccines used in cancer therapy. |
| 23 February 2024 | FOI 4959 | Correspondence received by Health Minister’s Office regarding LifeVac |
| 30 January 2024 | FOI 4834 | Personal Injury documents regarding Oxiplex AP |
| 24 January 2024 | FOI 4857 | Registration status of Scopolamine Transdermal Patches |
| 15 January 2024 | FOI 4863 | Medicinal Cannabis data taken from six-monthly reports from product sponsors between 1 January 2021 and 30 June 2023 |
| 3 January 2024 | FOI 4842 | A copy of the report received by the TGA on 2 October 2021 for a ‘Report of a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products’ in relation to the ‘HQD Cuvie plus disposable vape’ |
| 3 January 2024 | FOI 4855 | Applications successful, pending and unsuccessful to access psilocybin and/or MDMA through the Authorised Prescriber scheme from 1 July to 1 December 2023 |
| 22 December 2023 | FOI 4838 | Medicinal Cannabis Special Access Scheme applications from 1 July 2021 to 30 June 2023 |
| 21 December 2023 | FOI 4784 | Food Medicine Interface (FMI) assessment for Souvenaid and assessment of Neurofolin FSMP |
| 21 December 2023 | FOI 4784 | Non-clinical evaluation report for the active constituent selinexor in Xpovio tablets |
| 21 December 2023 | FOI 4702 | Incident reports, investigations and notices for Medtronic Circular Stapler Gun |
| 7 December 2023 | FOI 4382 | Laboratory testing of Comirnaty and Spikevax COVID-19 vaccines |
| 6 December 2023 | FOI 4529 | Documents relating to the M6-C TOR artificial cervical disc device sponsored by Life Healthcare Pty Ltd |
| 4 December 2023 | FOI 4764 | Data relating to the unlawful advertising of medicinal cannabis and compliance actions |
| 27 November 2023 | FOI 4788 | Authorised Prescriber and Special Access Scheme data for MDMA and Psilocybin from January 2020 to 27 October 2023 |
| 17 November 2023 | FOI 4769 | Documents relating to COVID-19 vaccine Adverse Event reports |
| 13 November 2023 | FOI 4695 | Documents relating to Therapeutic Goods Orders and Instruments and other documents concerning Neurofolin |
| 9 November 2023 | FOI 4723 | Briefings prepared for the minister by the department regarding the decision in 2016 to downschedule cannabis and tetrahydrocannabinols from schedule 9 to schedule 8 |
| 16 October 2023 | FOI 4604 | Briefings provided to the Minister for Health from 2 March – 2 May 2023 relating to the banning of vaping products |
| 16 October 2023 | FOI 4575 | Correspondence between the TGA and Mind Medicine Australia prior to 24 October 2022 |
| 16 October 2023 | FOI 4712 | Special Access Scheme reporting data for medicinal cannabis for 1 January - 30 June 2023 |
| 12 October 2023 | FOI 4679 | Medicinal Cannabis Special Access Scheme and Authorised Prescriber data for 1 July 2022 to 30 June 2023 |
| 4 October 2023 | FOI 4558 | Batch testing for the Pfizer/BioNTech vaccine 6 documents released in part, with redactions applied under section 22 (material not in scope of the request) and section 47 (material considered as commercially sensitive) |
| 14 September 2023 | FOI 4516 | Professor David Nutt’s presentation on Psilocybin and MDMA therapy |
| 4 September 2023 | FOI 4401 | Correspondence between the TGA and Western Australian Police Force and/or Western Australian Police Prosecuting Service concerning Ivermectin and high-level documents such as briefs prepared for the TGA Executive that relate to the safety of Ivermectin in relation to the Poisons Standard Amendment (Ivermectin) Instrument 2021 |
| 30 August 2023 | FOI 4595 | Authorised Prescriber data for MDMA and Psilocybin and Special Access Scheme data for psychedelic therapies |
| 29 August 2023 | FOI 4583 | Special Access Scheme Category B applications for pentosan polysulfate sodium (PPS) or pentosan polysulphate sodium (PPS) from 1 January 2017 to 30 June 2023 |
| 27 August 2023 | FOI 4482 | High level briefs in relation to misuse of Lyrica (Pregabalin) |
| 10 August 2023 | FOI 4472 | Product Information (PI) for withdrawn product - THAM trometamol 18g/500mL injection bottle (AUST R 29691) |
| 7 August 2023 | FOI 4414 | Documents relating to scheduling decisions of Ivermectin for the treatment of COVID-19 |
| 1 August 2023 | FOI 4434 | Causality Assessment of DAEN case 682908 |
| 31 July 2023 | FOI 4502 | Data relating to indications for Special Access Scheme applications for Leuprofelin and Goserelin |
| 28 July 2023 | FOI 4363 | Documents held by TGA Senior Executive Staff mentioning Senator Gerard Rennick regarding COVID-19 vaccines for the period 1 - 14 February 2023 |
| 25 July 2023 | FOI 4452 | Documents showing date of TGA audit of Slade Health Pty Ltd |
| 20 July 2023 | FOI 4466 | Special Access Scheme, Authorised Prescriber & Adverse Event reports for radiopharmaceutical products |
| 20 July 2023 | FOI 4499 | SAS & AP data for Medicinal Cannabis from 1 July - 31 December 2022 |
| 19 July 2023 | FOI 4404 | Communications between Senator Rennick and TGA SES Staff between 15 November 2022 and 8 May 2023 |
| 17 July 2023 | FOI 4421 | Special Access Scheme and Authorised Prescriber data for Sodium Thiosulfate (Sodium Thiosulphate) Injections |
| 11 July 2023 | FOI 4320 | Documents relating to the evaluation of the Pfizer, AstraZeneca and Moderna COVID-19 vaccines |
| 5 July 2023 | FOI 4430 | Allergan textured breast implants: request for Appendix Table 1 in Document 4 previously released under FOI 2377 |
| 3 July 2023 | FOI 4280 | Documents relating to the registration of Sublocade, Subutex and Suboxone |