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Therapeutic Goods Administration (TGA) | Australian Government Department of Health

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Nicotine vaping products

The law regulating imports of nicotine vaping products changed on 1 October 2021.

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Nicotine vaping products webinar, 20 October 2021

Nictotine vaping webinar for healthcare practitioners

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Consent to supply medical devices that are non-compliant with the EPs

This webinar will guide you through the new online form

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Non-compliant patient information material

This webinar will guide you through the new online form

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COVID-19

Latest regulatory and safety information on COVID-19 vaccines, treatments, face masks and medical devices

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Consumers

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Unapproved products

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Industry

Regulation basics

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Recalls and suspensions

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

23 September 2021

Consumer and regulatory updates

CHATTANOOGA Ultrasound Gel Products and Lotions

14 September 2021

Recall due to risk of bacterial contamination

Neutrogena Ultra Sheer Body Mist Sunscreen Spray SPF 50+ (aerosol sunscreen)

2 August 2021

Recall - Possible presence of benzene

Ospolot (sulthiame) tablets 200 mg

3 June 2021

Product Defect Alert - child-resistant caps may not function correctly

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Safety information

COVID-19 vaccine weekly safety report - 14-10-2021

14 October 2021

Information about the TGA's safety monitoring of COVID-19 vaccines.

Shortages of tocilizumab (Actemra) medicines

14 October 2021

The TGA published an Actemra (tocilizumab) shortage - consumer information sheet produced by Pain Australia

Pentosan polysulfate sodium and pigmentary maculopathy

11 October 2021

Health professionals are advised that the Product Information for pentosan polysulfate sodium has been updated with a warning about potential pigmentary maculopathy, especially after long-term use.

Pentosan polysulfate sodium (Elmiron)

11 October 2021

Safety advisory - Risk of pigmentary maculopathy (changes in the retina of the eye), especially after long-term use

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News

Submissions received: Proposed refinements to the requirements for medical device patient information materials

18 October 2021

Submissions published and summarised as part of a consultation on patient information materials.

TGA Provisional Approval of Roche Products Pty Ltd COVID-19 treatment, casirivimab + imdevimab (RONAPREVE)

18 October 2021

The TGA has provisionally approved the use of the Roche Products Pty Ltd combination therapy, casirivimab + imdevimab (RONAPREVE), for the treatment and prevention of COVID-19 in specific target populations.

COVID-19 rapid antigen self-tests that are approved in Australia

15 October 2021

A list of self-tests that are approved in Australia

Brukinsa

15 October 2021

Australian prescription medicine decision summary

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