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Documents released under Section 11C of the Freedom of Information Act 1982, Jul 2024 - Jun 2025

Published

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
27 June 202525-0161

Adverse event notifications and associated correspondence for Medtronic insulin pump models, MiniMed 600 Series Insulin Pumps, namely MiniMed 640G.

26 June 202525-0149

COVID-19: VERA document titled "VSS COVID19 vaccine AESI list and MedDRA codes and Intensive Drug Monitoring Program list in the AEMS Customer Relation Management Database (CRM) 'Special Interest' table. 

25 June 202525-0205

Decision-making process documentation and recommendations for the scheduling of Paracetamol to an over-the-counter 0.5g 50 tablet/capsule in a single package in a chemist.

16 June 202525-0169

Documents between TGA and Accord regarding sunscreen regulation, safety and innovation.

16 June 202525-0200

CBD-dominant oral liquid medicinal cannabis products approved under the Special Access Scheme Category B (SAS-B)

16 June 202525-0209

SAS C notifications for supply of vaping productsfrom 1 October 2024 – 31 May 2025.

13 June 202525-0162

Request for:

  1. all documents relating to testing the TGA has done on Vyvance. Date range: 1/1/2024 to date of acceptance
  2. all documents that Takeda has issued TGA about Vyvance testing or change of formula, or place of production. Date range 1/1/24 to date of acceptance.
6 June 202525-0153

Request for all emails/correspondence containing the name/phrase "Sin Hang Lee" from 1 January 2014 to 1 January 2017.

6 June 202525-0127

Documents relating to ARTG 343577 and ARTG 454945.

6 June 202525-0147

Documents relating to the addition of a meningioma warning to the Product Information for MPA containing products.

3 June 202525-0171

Documents in relation to the Orphan Drug Designation applications for Sodium Oxybate and Sebetralstat.

30 May 202525-0132

Documents relating to Caruso’s Prostate EZE Max.

26 May 2025 25-0194

Number of unique pharmacies that submitted notifications to the TGA under Schedule 3 (pharmacist notification of supply) for vaping products from 01/10/2024 to 30/04/2025.

26 May 202525-0186

Authorised Prescriber and Special Access Scheme data for MDMA and psilocybin for the period 1 July 2023 to 30 April 2025.

19 May 202525-0182

Special Access Scheme and Authorised Prescriber data for Naltrexone implants for the period 1 January 2023 to 31 March 2025.

16 May 202525-0170

Time To Death (TTD) data to include TTD for adverse event reports with MedDRA terms myocardial infarction, acute myocardial infarction and pulmonary embolism.

16 May 202525-0134

Unredacted copies of the Proportionality Reporting Ratio analyses for the COVID-19 vaccines to 22 October 2022 released in response to FOI request TGA FOI 4032

14 May 202525-0140

Documents relating to AUST R 225750 LIDOPHENYL SPRAY bottle, AUST R 364357 LIDOPHENYL SPRAY strawberry flavour nasal spray bottle and AUST R 364358 LIDOPHENYL SPRAY grape flavour nasal spray bottle.

12 May 202525-0179

Schedule 3 Special Access Scheme (SAS C) pharmacist notifications to TGA of supply of vaping products from 1 October 2024 – 31 March 2025

6 May 202525-0113

Documents relating to TGA’s targeted consultation on removal of glucagon-like-peptide-1 receptor agonist analogues from the pharmacist extemporaneous compounding exemption.

5 May 202525-0164

Documents relating to analysis assessing difference of reporting rates for adverse events between COVID-19 vaccines and other vaccines.

5 May 202525-0130

Documents relating to Depo-Provera branded products containing medroxyprogesterone acetate (MPA).

2 May 202525-0167

Data containing information on the number of units of unregistered medicinal cannabis products supplied for the period 1 July 2024 to 31 December 2024.

1 May 202525-0137

Plasmid maps for selected vaccines: 

  1. Shingrix
  2. Gardasil Quad
  3. Gardasil 9
  4. Bexsero
22 April 202525-0136

Request for all briefing notes provided to Dr Lisa Kerr for Senate Estimates attendances during 2024.

22 April 202525-0146

Documents and correspondence related to the TGA’s sunscreen literature review publication.

17 April 202525-0143

Regarding the post market review of energy-based devices used for vaginal rejuvenation, applicant seeks copy of expert advice provided by Advisory Committee on Medical Devices (ACMD). 

3 April 202525-0094

COVID-19: Proportionality Reporting Ratio analyses (DPARS) produced for covid-19 vaccines from 1 October 2022. 

3 April 202525-0156

Document from Senate Estimates on 26 February 2025 relating to the Bhattacharjee Yale preprint article.

1 April 202525-0157

Request for SAS data for Aldesleukin/Interleukin-2 (IL-2) or Proleukin.

1 April 202525-0150

List provided under FOI 25-0047, of time to death data on the Database of Adverse Events Notifications (DAEN) where Medical Dictionary for Regulatory Activities (MedDRA) term “cardiac arrest” was submitted. 

31 March 202525-0115

Adverse event information regarding COVID-19 vaccines and specific cases.

28 March 202525-0151

Laboratory reports for Iverguard, manufactured by Fortune Healthcare Product.

26 March 202525-0152

Copies of the breakdown by month and State of the number of requests for scans under the TGA Special Access Scheme for categories A, B or C using the listed products.

21 March 202525-0119

All held records, documents, emails and/or communications regarding TGA case number 746367.

18 March 202525-0145

Unregistered medicinal cannabis products supplied for the period 1 Jul 2024 to 31 December 2024, taken from the six-monthly reports submitted by product sponsors.

12 March 202525-0078

List of unregistered medicinal cannabis products supplied (by name) for the period 1 July 2024 to 31 December 2024 as taken from the six-monthly reports submitted by product sponsors.

12 March 202525-0117

Adverse event information regarding COVID-19 vaccines and specific cases.

These documents represent a 'point in time' assessment of information available to the TGA on the date of assessment. They are subject to ongoing review as new information comes to light and do not represent a final conclusion or final decision. Even when the TGA does not have sufficient information to undertake a causality assessment at a particular point in time (WHO criteria = U or unassessable/unclassifiable), the TGA continues to code all reports with fatal outcome as ''possibly" linked to COVID-19 vaccination. These cases are included in analyses of adverse event data to identify and investigate signals that may not be apparent through review of individual cases. This is consistent with the approach recommended by the WHO and used by other major global regulators and vaccine safety monitoring programs. 

The point-in-time causality decision included in these documents may be expressed in a variety of ways. In some documents, no decision has been made and the template text "causality" or text in square brackets remains. For other documents, WHO criteria is listed in the document and may be expressed as unassessable/lunclassifiable (coded as "U'') and "unlikely". This explanation has been included due to some misunderstandings about these words.

7 March 202525-0095

Request for finalised TGA signal notification assessments, signal investigation and signal evaluation documents for the potential safety signals of COVID-19 vaccines and diabetes, COVID-19 vaccines and Alzheimer’s disease, and COVID-19 vaccines and cerebrovascular accident.

6 March 202525-0139

Approvals and rejections given by the TGA to use MDMA and psilocybin under the Authorised Prescriber Scheme.

24 February 202525-0100

Non-clinical evaluation reports for Nuvaxovid.

18 February 202525-0108

Documents relating to ARTG ID 455591 and ARTG ID 455173.

17 February 202525-0129

Special Access Scheme and Authorised Prescriber data for any nelarabine product from 1 October 2023 to 3 February 2024.

10 February 202525-0049

Correspondence between the Minister for Health and the TGA regarding 'vapes', 'vaping', 'e-cigarettes' and 'notified list'.

7 February 202525-0123

List of unregistered medicinal cannabis products supplied (by name) for the period 1 July 2023 to 31 December 2023 as taken from the six-monthly reports submitted by product sponsor.

7 February 202525-0121

List of unregistered medicinal cannabis products supplied (by name) for the period 1 January 2023 to 30 June 2023 as taken from the six-monthly reports submitted by product sponsor.

5 February 202525-0118

Request for Certificates of Analysis following the testing of counterfeit therapeutic goods.

31 January 202525-0104

Draft sunscreen ingredient safety assessment document prepared as part of the TGA review of sunscreen active ingredients.

15 January 202525-0079

All documents mentioning ‘Harrison.ai’ between 15 September 2024 to 15 October 2024. 

9 January 202525-0092

List of medicinal cannabis entities that have received a warning letter or infringement notice relating to the unlawful advertising of medicinal cannabis for the period 1/1/2024 to 28/11/2024. 

8 January 202525-0009

TGA safety assessment used to determine the permissible concentrations of multiple chemical UV filters / the Comparable Oversees Regulator used to determine the safety of each ingredient.

24 December 202425-0083

Documents regarding ARTG 227865.

24 December 202425-0089

Documents relating to the medDRA term 'adverse event following immunisation'.

24 December 2024FOI 25-0081

Summary of FOI charges from 5 November 2023 to 5 November 2024. 

24 December 2024FOI 25-0070

Drafts of document ‘Addressing misinformation about excessive DNA in the mRNA vaccines’ and documents relating to the creation of this document.

24 December 2024FOI 25-0069

1. Document ‘SOP-1020’ referenced in the document released under TGA FOI 5286. 
2. The invoices for all primers and probes purchased for the analysis of the Moderna mRNA vaccine qPCR as outlined in the document ‘Method - rDNA quantitation in Moderna Vaccines by qPCR’ released under FOI 5286

23 December 2024FOI 25-0056

Request for documents regarding Losec, Nexium, Nexium 24hr, Somac, Zoton FasTabs and Pariet (PPI innovator drugs) for: 

  1. Safety signals and evolution of warnings in PI and CMI; and
  2. Adverse events submitted to Database of Adverse Event Notifications (DAEN); and
  3. Documents related to 'signal notifications'
23 December 2024FOI 25-0019

Product Information for innovator Moxifloxacin from 1 January 2014 to 20 June 2024.

23 December 2024FOI 25-0028

Product Information for Roxin from 1 January 2014 to 20 June 2024.

20 December 2024FOI 25-0055

Documents relating to Phillips Electronics infringement notices. 

19 December 2024FOI 25-0093

A list of case numbers for the adverse events relating to the ‘time to death’ data provided in documents 1 and 2 for FOI 25-0047. 

19 December 2024FOI 25-0087

'Appendix viral vaccines summary of product testing and release criteria' document.

17 December 2024FOI 25-0058

All correspondence related to the production of the webpage and associated social media posts regarding allegations of DNA contamination in mRNA vaccines.

13 December 2024FOI 25-0018

Product Information for innovator Ciprofloxacin from 1 January 2014 to 11 June 2024.

11 December 2024FOI 25-0084

Data on all adverse event report numbers and age included in the DAEN - medicines with report date from 1 January 2004 to 26 October 2024.

11 December 2024FOI 25-0010

Documents relating to Trolamine Salicylate.

10 December 2024FOI 25- 0017

Regulation of sunscreen and correspondence with sunscreen industry regarding regulation of chemical UV filters.

9 December 2024FOI 25-0031

Documents relating to incidents and complaints for Allergan Biocell Rough Textured Breast Implants.

9 December 2024FOI 25-0085

Data containing Special Access Scheme and Authorised Prescriber approvals for deflazacort and mexiletine tablets for the period 1 January 2021 to 30 July 2024.

9 December 2024FOI 25-0046

The invoice and a document that contains the scope of the project related to:  Venue Hire - Hotels and lodging and meeting facilities: Marriott Courtyard Siem Reap - AusTender Contract Notice: CN4093808.

4 December 2024FOI 25-0048

Documents relating to Meditab Loratadine Solution 1 mg/mL oral liquid bottle AUST R 164482.

29 November 2024FOI 25- 0012

Previous versions of Product Information and Consumer Medicine Information documents for Ferinject.

26 November 2024FOI 5298

Documents relating to the approval to vary clinical aspects of the Product Information for Infanrix Hexa in June 2006.

18 November 2024FOI 25-0080

Special Access Scheme data for Oritavancin for the period 
1 January 2018 to 31 October 2024.

12 November 2024FOI 5350

Documents in the possession of the office of the Deputy Secretary and/or the Chief Medical Advisor since 1 January 2024 that relate to the causes - known, suspected or speculated - of shortages of intravenous fluid products in Australia.

Please note that the documents represent a point in time early on in the shortage. Refer to the TGA website for the most up to date information on medicine shortages.

12 November 2024FOI 25-0001

Documents relating to the haemoperfusion device manufactured by Foshun Biosun Medical Technology Co. Ltd (Biosun).

11 November 2024FOI 25-0043

List of unregistered medicinal cannabis products supplied for the period 1 January 2024 to 30 June 2024.

11 November 2024FOI 5348

Summary of all payments received from Pfizer, AstraZeneca, and Moderna from 1 July 2019 to 1 July 2024

8 November 2024FOI 25-0047

Two spreadsheets generated outlining adverse event reports (AERs) in the Adverse Event Management System (AEMS) for the following:

  1. Adverse event report data for the time between the most recent non-covid vaccination and death, for the timeframe of 1 January 2004 to 5 September 2024 for accepted cases.
  2. Adverse event report data for the time between the most recent covid-19 vaccination and death for the timeframe of 1 December 2020 to 5 September 2024 for accepted cases.
7 November 2024FOI 5351

Documents relating to the Advisory Committee on Medicines Minutes of meeting 44 (Section B Post-market items Sodium Valproate), including ratified minutes, presentation slides and agenda pack.

4 November 2024FOI 25-0045

Copies of Good Manufacturing Practices (GMP) audit checklists, used for listed medicines manufacture.

1 November 2024FOI 5343

Ministerial submissions and briefings provided by the Department to the Minister for Health and Care, the Hon Mark Butler MP since 1 January 2024 that relate to shortages in Australia of intravenous (IV) fluid products.  

Please note that the document represents a point in time early on in the shortage. Refer to the TGA website for the most up to date information on medicine shortages.

31 October 2024FOI 25-0037

Request for the 30 most recent FOI charges notices. Any subsequent decisions regarding contentions over charges and decisions on Internal Review or Information Commissioner reviews of charges.

24 October 2024FOI 25-0033

Request for first document that suggests there may be an internal signal detection showing there may be a correlation between MRNA vaccine and death in the elderly.

24 October 2024FOI 25-0002

Approvals given by the TGA to use Sodium Thiosulfate under the Special Access Scheme (SAS) and Authorised Prescriber Scheme (APS).

17 October 2024FOI 25-0025

Special Access Scheme data for multiple scan products for the period
1 January 2021 to 17 September 2024.

17 October 2024FOI 5276

Request for documents relating to TGA's approval and pharmacovigilance for Gardasil 4 (2007-2015).

16 October 2024FOI 25-0029

Special Access Scheme Category A, B and C data sets for triclabendazole, ibrexafungerp, flucytosine, diethylcarbamazine, levofloxacin and fumagillin.

15 October 2024FOI 25-0034

Product Information and Consumer Medicine Information documents for Capecitabine-DRLA (Capecitabine) Tablets as of 14 September 2020.

15 October 2024FOI 3121

Documents relating to evidence for the efficacy of Caruso’s ‘Prostate EZE Max.’

14 October 2024FOI 5280

Approval documents relating to Wegovy, including the Delegate's Overview, Clinical Evaluation report and Non-Clinical Evaluation report.

4 October 2024FOI 5199

Documents relating to laboratory testing of Spikevax vaccines.

4 October 2024FOI 5202

Evidence of website edits related to SAS procedures.

4 October 2024FOI 25-0008

Eleven ARTG summary printouts for cancelled breast implant products.

25 September 2024FOI 25-0003

Data of unregistered medicinal cannabis products supplied for the period 1 January 2024 to 30 June 2024, taken from the six-monthly reports submitted by product sponsors.

24 September 2024FOI 5353

COVID-19: Request for a list of DAEN notifications of the 1004 deaths notified "COVID vaccine safety report 2/11/23".

20 September 2024FOI 5360

Three spreadsheets generated outlining adverse event reports (AERs) in the Adverse Event Management System (AEMS) for the following:

  1. Case number and age for adverse events with a fatal outcome that involve a non-covid vaccine, for the timeframe of 1 January 2004 to 14 August 2024 including both accepted and rejected cases.
  2. Adverse event report data for the time between the most recent non-covid vaccination and death, for the timeframe of 1 January 2004 to 14 August 2024 including both accepted and rejected cases.
  3. Adverse event report data for the time between the most recent covid-19 vaccination and death for the timeframe of 1 December 2020 to 14 August 2024 including both accepted and rejected cases.
20 September 2024FOI 5358

Two spreadsheets generated outlining case numbers and age (years) for all adverse event reports in AEMS database for non-covid and covid vaccines between 1 Jan 2004 to 6 Sep 2024.

19 September 2024FOI 5286

Protocol for assessing the presence of residual DNA in the mRNA COVID-19 vaccine products provisionally approved by the TGA.

17 September 2024FOI 5179

Documents relating to TGA reference number ARTG 225818 Safe Obstetrics Systems foetal membrane

13 September 2024FOI 5357

Special Access Scheme and Authorised Prescriber data for ‘Glycopyrrolate’ from 1 January 2023 to 1 March 2024

3 September 2024FOI 5347

Summary of charges for the last 30 finalised FOI requests

3 September 2024FOI 4957

Documents relating to the registration of certain generic drugs

30 August 2024FOI 5321

List of all import referrals to TGA received from Australian Border Force regarding Semaglutide

28 August 2024FOI 5317

Special Access Scheme and Authorised Prescriber data for Dalbavancin for the period 1 January 2021 to 30 June 2024.

28 August 2024FOI 5169

Documents related to the risk of kidney injury/disease or gastric cancer as a result of the usage of proton pump inhibitors 

26 August 2024FOI 5293

COVID-19 Adverse Event Reports and List of Serious Cases

23 August 2024FOI 5275

COVID-19:  Document detailing generalised information on the authors of relevant supporting documents that informed the AusPAR for Comirnaty BNT162b2.

22 August 2024FOI 5308

Special Access Scheme Category A and B applications granted for unregistered antimicrobials from January 2017 to December 2023

21 August 2024FOI 5171

Delegate’s Overview for Lexapro

16 August 2024FOI 5316

Authorised prescriber approvals for Psilocybin and MDMA from 1 July 2023 to 30 June 2024

16 August 2024FOI 5049

Non-clinical evaluation report for pregabalin in Lyrica

15 August 2024FOI 5107

Emails and notifications received by the TGA containing "Relx", "QuitRX" and "Quitmed"

14 August 2024FOI 5255

Data relating to Authorised Prescriber and Special Access Scheme pathways for medicinal cannabis

8 August 2024FOI 5023

Documents relating to SPL7013, Astodrimer, Viraleze and Starpharma

5 August 2024FOI 5224

List of all new chemical and biological entities approved by the TGA

2 August 2024FOI 1890

Safety Study Test for the approval and registration of the first Gardasil vaccine.

1 August 2024FOI 5170

Briefing documents prepared by the TGA for the Minister for Health and Aged Care regarding safety issues associated with antidepressants, antipsychotics, benzodiazepines and z-drugs

26 July 2024FOI 5082

Documents relating to COVID-19 vaccine safety signal investigation processes.

Product Information (PI) documents, published on the TGA website, are the most up-to-date reference for adverse events associated with individual COVID-19 vaccines products. The following document may refer to statistical signals that were not confirmed for further review, that were not found to be clinically meaningful, or that were unable to be validated with population-evidence sufficient to confirm an association. Internal TGA Standard Operating Procedures (SOP) and Work Instructions (WI) are designed for use by persons who have undertaken formal TGA induction and on-the-job training. It would be inappropriate for these documents to be utilised as written by someone who is not orientated to the science of pharmacovigilance and the work of the organisation.

24 July 2024FOI 5137

Consumer Medicine Information (CMI) and Product Information (PI) documents for Loxalate, Lexapro, Chemmart Brand Escitalopram, Escitalopram

18 July 2024FOI 5046

Documents relating to the assessment and approval of Nirsevimab (Beyfortus)

15 July 2024FOI 5201

Special Access Scheme and Authorised Prescriber data for [18F]Fluorodeoxyglucose (FDG) PET scans performed for brain cancer for the period 1 January 2018 to 1 June 2024

12 July 2024FOI 5192

Confirmation of cancellation and date of cancellation for Natrelle Saline-Filled Breast Implants, including styles SRL, SRF, SRM and SRX and Natrelle Silicone-Filled Textured Breast Implants, including styles SRL, SRF, SRM and SRX

4 July 2024FOI 5205

COVID-19: Adverse event data with time to onset included and concomitant medicine information excluded.