The documents are available for downloading and printing. If you require access to the documents in an alternative format please contact the FOI Contact Officer by emailing foi@health.gov.au or calling the Department of Health on 1800 020 103 or 02 6289 1555.
| Date of release | FOI number | Documents |
|---|---|---|
| 30 June 2026 | 26-3221 | Medicinal cannabis supply data.
|
| 29 June 2026 | 26-2992 | Shortages of Aripena from 1 August 2025 to 15 April 2026. |
| 29 June 2026 | 26-3204 | Schedule 3 Special Access Scheme (SAS C) pharmacist notifications to TGA of supply of vaping products from 1 October 2024 - 31 May 2026. |
| 25 June 2026 | 26-3268 | Updated data in relation to Medical Dictionary for Regulatory Activities (MedDRA) code 10086208. |
| 22 June 2026 | 26-2678 | GPvP inspection reports with critical and/or major findings for inspections conducted from 01-Jan-2023 to 31-Dec-2023.
|
| 19 June 2026 | 26-3205 | SAS-B Data for Cystaran & Mercaptamine from 1 January 2018 to 30 May 2026. |
| 18 June 2026 | 26-3001 | Further information regarding Adverse Event Reports.
|
| 17 June 2026 | 26-2978 | Product Information, Consumer Medicine Information and product packaging amendments for Zoton (ARTG 153575).
|
| 15 June 2026 | 26-2970 | Documents relating to the potential impact of the Middle Eastern conflict on medicine availability.
|
| 12 June 2026 | 26-2980 | Manufacturing details of Somac, Zoton and Pariet.
|
| 10 June 2026 | 26-3068 | Document (and drafts of) referred to at Senate estimates on 11 February 2026 in relation to question on COVID-19 paediatric deaths causality. |
| 5 June 2026 | 26-3110 | AusVaxSafety Annual Report 2022 - COVID-19 vaccines content.
|
| 5 June 2026 | 26-3095 | Adverse event information for medicinal cannabis products.
|
| 27 May 2026 | 26-3097 | Special Access Scheme and Authorised Prescriber data for methoxsalen for the period 1 January 2022 to 30 April 2026. |
| 27 May 2026 | 26-3057 | Special Access Scheme Category C pharmacist notifications for supply of vaping products from 1 October 2024 – 30 April 2026.
|
| 21 May 2026 | 26-2841 | Request for historical CMI documents for multiple ARTG entries. |
| 20 May 2026 | 26-2387 | Documents held by TGA regarding denosumab (Prolia/Xgeva) from 1 January 2013 to 3 November 2025, specifically for:
|
| 18 May 2026 | 26-2817 | Manufacturer details for Nexium and Losec.
|
| 18 May 2026 | 26-2819 | Documents related to reporting by the ABC regarding sunscreen testing in December 2025
|
| 18 May 2026 | 26-2853 | Documents relating to TGA decision notice LMP-SP-2025-00914
|
| 15 May 2026 | 26-3014 | Correspondence from the TGA to Medtronic regarding spinal cord stimulator adverse events. |
| 14 May 2026 | 26-3032 | Special Access Scheme (SAS) & Authorised Prescriber (AP) data for medicinal cannabis 1/6/2024 to 30/04/2026. |
| 12 May 2026 | 26-3013 | Product Information (PI) and Consumer Medicines Information (CMI) for ARTG 286437. |
| 4 May 2026 | 26-2879 | Documents relating to the adequacy of the device incidence report system (MDIR).
|
| 28 April 2026 | 26-2687 | Legal Advice Sought by the TGA.
|
| 24 April 2026 | 26-2680 | Documents related to the recall of several 0.9% Sodium Chloride products.
|
| 23 April 2026 | 26-2820 | Special Access Scheme (SAS) & Authorised Prescriber (AP) submissions for dalbavancin and oritavancin.
|
| 22 April 2026 | 26-2921 | Data in relation to Medical Dictionary for Regulatory Activities (MedDRA) code 10086208.
FOI 26-2921
[PDF, 47.78 KB]
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| 22 April 2026 | 26-2686 | Documents relating to correspondence LMP-SP-2025-00914 – TRIM: E25-654256 and LMP-SP-2025-00914 – TRIM: E25-693483 issued by the TGA.
|
| 21 April 2026 | 26-2926 | Special Access Scheme Category C pharmacist notifications for supply of vaping products from 1 October 2024 – 31 March 2026. |
| 20 April 2026 | 26-2571 | Site inspection reports for GMP Pharmaceuticals. |
| 14 April 2026 | 26-2496 | Documents related to investigations undertaken by TGA relating to the importation of unregistered Ayurvedic medicines. |
| 14 April 2026 | 26-2843 | Medicines containing metoprolol succinate modified-release (extended-release) tablets that have been sponsored by AstraZeneca Pty Ltd. |
| 10 April 2026 | 26-2886 | The discussion paper submitted by the Therapeutic Goods Administration to the Advisory Committee on Medicines Scheduling for its meeting between March 17 and 19 2026. |
| 9 April 2026 | 26-2880 | Records relating to the inclusion of ARTG entry 205544 (Trinity Biotech MarDx EU Lyme + VlsE IgG/IgM Western Blot). |
| 9 April 2026 | 26-2747 | Documents and correspondences regarding the Exactech Equinoxe Reverse total Shoulder Arthroplasty System. |
| 9 April 2026 | 26-2009 | Documents that directly reference the application progress (any pause, hold, withdrawal and reasons) specifically in relation to the XBB.1.5 formulation (also known as the Nuvaxovid COVID-19 Vaccine for the 2023-2024 season or NVX-CoV2601). |
| 31 March 2026 | 26-2705 | The “Institutional profile”, “Terms of Reference” and “Workplan” for the TGA World Health Organisation (WHO) Collaborating Centres operating for each four-year term. |
| 31 March 2026 | 26-2775 | Unregistered medicinal cannabis products supplied for the period 1/7/2025-31/12/2025. |
| 30 March 2026 | 26-2688 | Documents relating to vitamin B6 labelling for select listed medicines. |
| 27 March 2026 | 26-2776 | Special Access Scheme Category C pharmacist notifications for supply of vaping products from 1 October 2024 – 28 February 2026. |
| 25 March 2026 | 26-2766 | FOI requests 26-2513 and 26-2571. |
| 25 March 2026 | 26-2757 | Documents related to the timing of the independent review of vaping. |
| 24 March 2026 | 26-2630 | Documents relating to the TGA’s decision on 4-MBC.
|
| 23 March 2026 | 26-2746 | TGA certificate for Philips M8023A #E25 power supply pack and the Avalon CL (866074). |
| 20 March 2026 | 26-2374 | TGA GMP inspection/audit reports for Wild Child Laboratories. |
| 19 March 2026 | 26-2572 | Documents relating to Good Manufacturing Practice inspection reports. |
| 16 March 2026 | 26-2716 | Information relating to the scheduling of trazodone.
|
| 16 March 2026 | 26-2619 | Financial records relating to regulatory fees and cost-recovery payments made to the Therapeutic Goods Administration (TGA) by: |
| 13 March 2026 | 26-2733 | Documents relating to ARTG certificate 199593. |
| 13 March 2026 | 26-2626 | Documents associated with TGA cancellation record for ARTG entry 205544 (Trinity Biotech MarDx EU Lyme + VlsE IgG/IgM Western Blot). |
| 11 March 2026 | 26-2697 | ARTG Summary document for ARTG 231433 – MyHealthTest Pty Ltd (Home Blood Collection Kit). |
| 5 March 2026 | 26-2639 | A list of the documents with page numbers and unique identifiers in response to the Request Consultation notice for FOI 26-2639. |
| 24 February 2026 | 26-2513 | Documents regarding Manufacturing Licence Application MI-2021-LI-10110-1.
|
| 24 February 2026 | 26-2451 | Product labels and summary sheet for specified Johnson & Johnson Pacific Pty Ltd products.
|
| 23 February 2026 | 26-2483 | Documents relating to sunscreen products. |
| 19 February 2026 | 26-2664 | Schedule 3 Special Access Scheme (SAS C) pharmacist notifications to TGA of supply of vaping products from 1 October 2024 – 31 January 2026. |
| 17 February 2026 | 26-2401 | TGA safety assessment advice on gonadotrophin-releasing hormone analogues (GnRHa). |
| 9 February 2026 | 26-2323 | Documents relating to the medical device ‘Profocal’ including Special Access Scheme (SAS) access, supply reports and adverse events. |
| 6 February 2026 | 26-2598 | Number of Special Access Scheme (SAS) and Authorised Prescriber (AP) approvals for Budesonide 4 mg extended-release (ER) capsules between 1 January 2022 to 31 October 2025. |
| 6 February 2026 | 26-2535 | Medicinal cannabis product data and TGA category. |
| 6 February 2026 | 26-2560 | Authorised Prescriber (AP) data for MDMA/Psilocybin. |
| 6 February 2026 | 26-2398 | Signals, notifications, or communications received by the TGA concerning sunscreen manufacturers. |
| 5 February 2026 | 26-2581 | Notice of Decision for FOI 5275. |
| 4 February 2026 | 26-2485 | Number of requests for scans under the SAS and AP schemes for Lutetium (177Lu) PSMA by state.
|
| 4 February 2026 | 26-2392 | Documents relating to Minister Butler’s October 2025 interview relating to sunscreens.
|
| 30 January 2026 | 26-2561 | Special Access Scheme Category C (SAS C) pharmacist notifications for supply of vaping products from 1 October 2024 – 31 December 2025. |
| 30 January 2026 | 26-2297 | Change notification document for the Lowenstein prisma SMART max device. |
| 28 January 2026 | 26-2459 | Documents informing TGA public statements around the safety of sunscreens and sunscreen ingredients. |
| 28 January 2026 | 26-2271 | Hazard alert regarding St Jude implantable devices. |
| 23 January 2026 | 26-2486 | • List of reports for MDCK cell derived vaccines use in pregnant women |
| 23 January 2026 | 26-2453 | Special Access Scheme and Authorised Prescriber data relating to prostate specific membrane antigen. |
| 16 January 2026 | 26-2437 | Email chains between the TGA and Seven West Media in relation to the LifeVac device. |
| 12 January 2026 | 26-2436 | Studies or assay outcomes relating to Cabazitaxel stability, particularly relating to the incompatibility of Cabazitaxel and polyurethane. |
| 12 January 2026 | 26-2352 26-2354 26-2355 | Cancellation of spinal cord stimulators (Medtronic, St Jude and Boston Scientific) and adverse event data.
|
| 5 January 2026 | 26-2157 | TGA permissible ingredients to UV filters used in sunscreens. |
| 23 December 2025 | 26-2331 | Copies of public guidance published by the TGA and Device Incident Reports no longer publicly available in relation to Face mask or respirators. |
| 22 December 2025 | 26-2488 | Data relating to Schedule 3 Special Access Scheme (SAS C) pharmacist notifications to TGA of supply of vaping products from 1 October 2024 to 30 November 2025. |
| 19 December 2025 | 26-2468 | Authorised Prescriber Approvals (MDMA & Psilocybin) and Authorised Prescriber Quarterly Usage Reports 1 July 2023 to 28 November 2025.
|
| 19 December 2025 | 26-2378 | Product labels, Product Information and Consumer Medicine Information, ARTG summary for Culmurid. |
| 18 December 2025 | 26-2393 | Recall and hazard alerts for Lentis Intraocular Lens. |
| 18 December 2025 | 26-2049 | Most recent GMP Inspection Reports between 1 January 2021 and 21 August 2025.
|
| 15 December 2025 | 26-2311 | Documents relating to the cancellation of Trinity Biotech MarDx EU Lyme + VlsE IgG/IgM Western Blot on the ARTG.
|
| 9 December 2025 | 26-2294 | Test results for Ivervid-12. |
| 4 December 2025 | 26-1972 | Correspondence between Novavax/Biocelect and the TGA concerning registration of Nuvaxovoid in the Australian Register of Therapeutic Goods. |
| 1 December 2025 | 26-2376 | Data relating to Schedule 3 Special Access Scheme (SAS C) pharmacist notifications to TGA of supply of vaping products from 1 October 2024 to 31 October 2025. |
| 28 November 2025 | 26-2095 | Notifications submitted to the TGA by Sandoz Pty Ltd regarding the shortages of Estradot 100 patches (AUST R: 338060). |
| 26 November 2025 | 26-2150 | Special Access Scheme and Authorised Prescriber data for Sodium Thiosulfate (Thiosulphate) for the period 1 January 2025 to 30 June 2025. |
| 26 November 2025 | 26-2338 | Complaints or correspondence mentioning ChatGPT from November 2022 to 23 October 2025. |
| 24 November 2025 | 26-2139 | GMP inspection of manufacturing site for GMP Pharmaceuticals. |
| 24 November 2025 | 26-2370 | Correspondence re: The Skin Doctor advertising injectable. |
| 21 November 2025 | 26-2273 | Product Information document for INTERGRILIN (eptifibatide). |
| 17 November 2025 | 26-2254 | Unredacted copies of 25-0162 documents. |
| 14 November 2025 | 26-2200 | Sponsor-initiated cancellation of ARTG 126550 and ARTG 282621. |
| 14 November 2025 | 26-2078 | Report listing overseas medicine manufacturing sites located in the People’s Republic of China that have been included in an active TGA GMP clearance for sterile injectable (parenteral) vials/bags, covering the manufacture of human medicines. |
| 7 November 2025 | 26-2312 | All ARTG-registered devices active from 1 July 2012 to 31 July 2025 under specified Global Medical Device Nomenclature (GMDN) codes. |
| 4 November 2025 | 26-2296 | Non-cannabis liquid medicines accessed under the Special Access Scheme. |
| 31 October 2025 | 26-2076 | Product and consumer information and product labels for Octreotide injection. |
| 31 October 2025 | 26-2256 | Data relating to the supply of vaping products via the Special Access Scheme Category C from 1 October 2024 to 30 September 2025. |
| 31 October 2025 | 26-2274 | Data relating to Special Access Scheme and Authorised Prescriber approvals for Levosimendan for infusion for the period 1 January 2024 to 31 July 2025. |
| 22 October 2025 | 26-2239 | Data relating to Special Access Scheme applications for Metyrapone, Ketoconazole, Tocilizumab, Rituximab and Unituxin for the period 2018 to 29 September 2025. |
| 17 October 2025 | 25-0212 | Two presentations of gynaecological dermatologist expert opinions regarding post-market review of energy based medical devices.
|
| 15 October 2025 | 26-2190 | Data relating to Special Access Scheme Category B and Authorised Prescribers for specific psychostimulants. |
| 14 October 2025 | 26-1958 | Documents relating to Iverjohn-12 and Ivervid-12 branded tablets. |
| 13 October 2025 | 26-1870 | Liber Pharmaceuticals involvement in 2024 vaping reforms. |
| 9 October 2025 | 26-2177 | Data relating to prescribed MDMA and Psilocybine. |
| 8 October 2025 | 26-2156 | Internal documents and correspondence regarding safety of sunscreen ingredients. |
| 7 October 2025 | 26-1990 | Approved carton and vial label artwork for Vidaza Powder for Injection, 100 mg. |
| 5 October 2025 | 26-2278 | Data on the number of units of unregistered medicinal cannabis products supplied for the period 1 January 2025 to 30 June 2025. |
| 30 September 2025 | 26-2142 | Data on the number of units of unregistered medicinal cannabis products supplied for the period 1 January 2025 to 30 June 2025. |
| 30 September 2025 | 26-2122 | Minutes of the 161st meeting of the Pharmaceutical Sub Committee of the Advisory Committee on Prescription Medicines on 24th March 2015 regarding the matter of preservatives in single use injections. |
| 30 September 2025 | 26-1879 | Copies of earliest iteration of product packaging for various over-the-counter medications. |
| 29 September 2025 | 26-2100 | Data relating to Schedule 3 Special Access Scheme (SAS C) pharmacist notifications to TGA of supply of vaping products from 1 October 2024 to 31 August 2025. |
| 29 September 2025 | 26-2102 | Data relating to medicinal cannabis SAS-B applications for the period November 2021 to 31 July 2025. |
| 29 September 2025 | 26-1874 | Copies of earliest iteration of product packaging for various over-the-counter medications. |
| 25 September 2025 | 25-0220 | Minutes of meetings where adverse event reporting rates are discussed in relation to COVID-19 vaccines. |
| 25 September 2025 | 25-0158 | TGA signal notification assessments, signal investigation and signal evaluation documents for the potential safety signals of COVID-19 vaccines for menstrual cycle irregularities/disorders. |
| 23 September 2025 | 26-2105 | The risk assessment matrix used by the TGA in relation to the LifeVac airway clearance device ARTG #285082.
|
| 23 September 2025 | 25-0216 | Documents relating to the Complementary and OTC Medicines Regulatory & Technical Forum (ComTech). |
| 11 September 2025 | 25-0214 | Device Incident Reports (DIR) and documents relating to Stryker Hip Stem (ARTG 145594) and Acetabular Shell (ARTG 152396). |
| 9 September 2025 | 25-0197 | Carton design, label design, product information and consumer medicine information relating to Depo-Provera (ARTG 12300, 12279 and 401610); and Depo‐Ralovera (ARTG 44464). |
| 8 September 2025 | 26-1867 | ARTG Certificates and Registration entries for Nitrostat (AUST R 438851 and 438870) and Anginine (AUST R 11086 and 227783). |
| 1 September 2025 | 26-1963 | Adverse event data for COVID-19 vaccines from 21 December 2020 to 31 July 2025. |
| 29 August 2025 | 26-1936 | Laboratory reports for Iverheal-12. |
| 29 August 2025 | 26-1978 | Schedule 3 Special Access Scheme (SAS C) pharmacist notifications to TGA of supply of vaping products from 1 October 2024 to 31 July 2025. |
| 27 August 2025 | 26-1889 | Documents relating to the cancellation of Bioglan Astragalus (ARTG ID 289150 from the Australian Register of Therapeutic Goods. |
| 26 August 2025 | 25-0211 | GMP Inspection reports for GMP Pharmaceuticals Pty Ltd as the licensed manufacturer. |
| 21 August 2025 | 25-0232 | TGA assessment report related to evaluation of ZO-RUB HP capsaicin 0.075% w/w cream tube (AUST R 198783). |
| 18 August 2025 | 25-0219 | Meeting minutes discussing Nicorette QuickMist (ARTG No. 197127) |
| 18 August 2025 | 25-0223 | Documentation relating to adverse reactions or potential adverse reactions for therapeutic sunscreens under the brand name Ultra Violette. |
| 15 August 2025 | 25-0206 | Documents relating to ARTG 295158 - Intense pulsed light skin surface treatment system. |
| 15 August 2025 | 25-0217 | Correspondence relating to the processing of FOI 25-0171 between the FOI requester and the TGA. |
| 7 August 2025 | 26-1890 | Adverse event notifications made to the TGA, and associated correspondence, for all unapproved medicinal cannabis products. |
| 6 August 2025 | 25-0199 | Documents related to internal audits conducted by the TGA’s Pharmaceutical Inspectorate. |
| 1 August 2025 | 25-0204 | Request for application, including any form of supporting documentation for ARTG 488139 – Dr Nature Immunity & Lung Tablet. |
| 30 July 2025 | 26-1888 | Special Access Scheme data for Cefiderocol for the period 1 January 2020 to 30 June 2025. |
| 28 July 2025 | 2565 | Toxicity studies of COVID-19 vaccines. |
| 24 July 2025 | 25-0233 | Special Access Scheme and Authorised Prescriber data for MDMA/psilocybin for the period 1 July 2023 to 30 June 2025. |
| 24 July 2025 | 26-1861 | Special Access Scheme (SAS) notifications of vaping supply from 1 October 2024 to 30 June 2025. |
| 22 July 2025 | 25-0165 | Documents relating to the reintroduction of Zantac in the Australian market. |
| 21 July 2025 | 25-0040 | Documents relating to menstrual problems following COVID-19 vaccination. |
| 14 July 2025 | 25-0222 | Spreadsheet containing time-to-death (TTD) data, attenuated to include only the TTD data for adverse event reports where the only coded MedDRA term is ‘adverse event following immunisation’. |
| 14 July 2025 | 2255 | Documents relating to COVID-19 otherwise known as Coronavirus Disease 2019 and SARS-CoV-2. |
| 7 July 2025 | 25-0417 | Documents relating to Boston Scientific Pty Ltd pacemakers. |