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FOI disclosure log


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22 June 2020

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
15 June 2020 FOI 1728

Request for the number of SAS category B approval for DMX-200 [Propagermanium] from July 2017 up to 19 May 2020, including how many were provided 2020 YTD.

15 June 2020 FOI 1664

Request for TGA clearance documents as submitted by Resonance Health Analysis Services Pty Ltd for FerriSmart artificial intelligence ARTG Entry: 296322.

12 June 2020 FOI 1704

Documents relating to TGA application for ARTG Entry 325343 - Eyetelligence Pty Ltd

9 June 2020 FOI 1675

Request for documents relating to '98 Alive Pty Ltd' products; details of exact composition (constituents and concentrations) of the melaleuca alternifolia oil active ingredient

11 May 2020 FOI 1474

Request for TGA Review of chemical scheduling in relation to cosmetic and fragrance ingredients

TBC FOI 1588

SAS Category B for medicinal cannabis products during the period 1/11/2016 to 12/03/2020

6 April 2020 FOI 1408

Request for documents relating to the Ethicon Endo Surgery intraluminal staples from 1/07/2012 to 30/07/2019

3 April 2020 FOI 1486

Request for documents regarding investigations into mass adverse events following administration of Gardasil at Sacred Heart College, Oakleigh, Victoria.

TBA FOI 1530

Request for documents relating to the registration and cancellation of the product Indocyanine Green or Cardiogreen

30 March 2020 FOI 1417

Request for all 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, during 2006 and 2007.

17 March 2020 FOI 1546

Request for the approved register entry and Product Information for Carboprost

4 March 2020 FOI 1429

Request for the TGA evaluation of Lyrica (Pregabalin) ahead of its initial entry on the Australian Register of Therapeutic Goods in 2005

4 March 2020 FOI 1539

SAS Category B for medicinal cannabis during the period 19/11/2019 to 14/02/2020

4 March 2020 FOI 1537

Number of new patients commencing treatment of unregistered medicinal cannabis products for specified time periods in 2019

24 February 2020 FOI 1482

Request for Philip Morris International's application to amend Schedule 7 of the Poisons Standard - commercially prepared and packed tobacco for personal use in Australia.

7 February 2020 FOI 1173

Documents relating to pre- and post-approval safety and performance issues of, and decision to discontinue supply of, the Essure device

5 February 2020 FOI 1296

Investigation into Lions Eye Bank NSW and infected corneal grafts

29 January 2020 FOI 1483

Special Access Scheme Category A and B notifications/approvals for Ketoconazole tablets for the period July 2016-June 2019

9 January 2020 FOI 1434

SAS Category B for medicinal cannabis from August 2019 - latest month

24 December 2019 FOI 1425

Request for the number of medical cannabis (MC) patients in Australia for the period August 2017 to October 2019

19 December 2019 FOI 1409

Special Access Scheme Category B pathway for medicinal cannabis from 1/9/2019 to 18/11/2019

16 December 2019 FOI 1324

Documents relating to pre-submission discussions relating to Sodium Oxybate or Xyrem

11 December 2019 FOI 1316

Documents relating to Special Access Scheme approvals and Adverse Event reports for Pentosan Polysulfate Sodium

9 December 2019 FOI 1368

Communication between TGA and ASADA relating to Thymosin Beta 4

21 November 2019 FOI 1356

Documents relating to Haemophilus Influenza B vaccine adverse event reports

14 November 2019 FOI 1327

Document showing sender type of DAEN reports on vaccine injury or death

13 November 2019 FOI 1299

PI and CMI documents for Oxycontin, Oxynorm capsules, Oxynorm liquids, Oxynorm tablets, Targin, Fentora, Actiq from 2000 to preceding the current online versions.

5 November 2019 FOI 1366

Documents relating to Hepatitis A vaccines adverse reaction reports in the Adverse Event Management System, not included in the public Database of Adverse Event Notifications

5 November 2019 FOI 1340

Documents relating to Varivax & Varilrix adverse reaction reports in the Adverse Event Management System, not included in the public Database of Adverse Event Notifications

1 November 2019 FOI 1370

Documents relating to Special Access Scheme/ Authorised Prescriber applications/notifications for vasopressin injection.

30 October 2019 FOI 1349

Documents relating to Special One (1) document Access Scheme Category A released in full and B approvals/notifications. Category A: from 1/07/2018 to 16/07/2019 Category B: from 28/09/2018 to 27/09/2019

29 October 2019 FOI 1360

SAS Category A, B and C approvals for Fesoterodine for the period July 2017 to July 2019

29 October 2019 FOI 1353

Documents relating to adverse event reports for the Priorix and Pulserix vaccines contained in the Adverse Event Management System, not included in the Database of Adverse Event Notifications.

29 October 2019 FOI 1345

Request for documents relating to Infanrix Ifexa vaccine adverse reaction notifications contained within the Adverse Event Management System.

15 October 2019 FOI 1338

SAS Category B applications for human dermis grafts in 2019

15 October 2019 FOI 1311

Request for documents relating to Special Access Scheme Category B pathway for medicinal cannabis products for the period 1/11/2016 to 31/08/2019

10 October 2019 FOI 1310

Special Access Scheme Category A notifications for carboprost and thiotepa in 2018

1 October 2019 FOI 1269

Documents relating to Afluria Quad, Fluad, Flu Quadri, & Flu Quadri Junior, Fluvax, and Fluvax Junior vaccine adverse reaction notifications in the Adverse Event Management System, not included in the public Database of Adverse Event Notifications

20 September 2019 FOI 1265

Documents relating to adverse reactions to the Fluzone high dose vaccine recorded in the Adverse Event Management System (AEMS) and not the Database of Adverse Event Notifications (DAEN)

19 September 2019 FOI 1258-1920

Documents relating to adverse reactions to rotavirus vaccines recorded in the Adverse Event Management System (AEMS) and not the Database of Adverse Event Notifications (DAEN)

18 September 2019 FOI 1262-1920

Documents relating to adverse reactions to Hepatitis B vaccines recorded in the Adverse Event Management System (AEMS) and not the Database of Adverse Event Notifications (DAEN)

16 September 2019 FOI 1261

Document relating to adverse reactions to Priox Tetra & ProQuad vaccines recorded in the Adverse Event Management System (AEMS) and not the Database of Adverse Event Notifications (DAEN)

13 September 2019 FOI 1139

Documents relating to the safety, efficacy and use of Risperdal

12 September 2019 FOI 1263

Documents relating to adverse reactions to the Zostavax vaccine recorded in the Adverse Event Management System (AEMS) and not the Database of Adverse Event Notifications (DAEN)

9 September 2019 FOI 1259

Documents relating to adverse reactions to MMR II & MM vax vaccines recorded in the Adverse Event Management System (AEMS) and not the Database of Adverse Event Notifications (DAEN)

6 September 2019 FOI 1260

Documents relating to adverse reactions to pneumococcal vaccines recorded in the Adverse Event Management System (AEMS) and not the Database of Adverse Event Notifications (DAEN)

4 September 2019 FOI 1258

Documents relating to adverse reactions to the Zostavax vaccine recorded in the Adverse Event Management System (AEMS) and not the Database of Adverse Event Notifications (DAEN)

30 August 2019 FOI 1187

Correspondence between TGA and surgeon about PIP implants from 1 September 2006 – 31 August 2016

28 August 2019 FOI 1194-1819

Listing of clinical studies for Duloxetine (pre-CTD)

12 August 2019 FOI 1222

Category B Special Access Scheme applications for medicinal cannabis products received from 16 March to 1 July 2019

18 July 2019 FOI 1188-1819

Request for adverse event reports received by the TGA for all Human Papilloma Virus vaccines that reported an outcome of death, including abortion

17 July 2019 FOI 1117

Request for correspondence about the application to import/use, and adverse event reports relating to the Birmingham Hip Replacement system.

17 July 2019 FOI 1132-1819

Request for a copy of the application to schedule Thymosin Beta 4 and Tb500

Section 22(1): Irrelevant information was redacted.

10 July 2019 FOI 1110-1819

Request for access to documents relating to Clinical Trial Exemption reviews conducted between July 2013 and July 2018

S47(1)(b): Document contains information that has commercial value that could reasonably be expected to be destroyed or diminished if it were disclosed was exempted and redacted.

10 July 2019 FOI 1103-1819

Request for correspondence between the TGA and Stephen Dank

9 July 2019 FOI 1177-1819

Request for documents regarding the Special Access Scheme Category B pathway for medicinal cannabis from 15/3/2019 to 31/5/2019.

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