Articles

On 19 January 2022 the TGA granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) in relation to the COVID-19 vaccine, NVX-CoV2373, for individuals aged 18 years and over.

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 18 January 2022.

This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Treatment—Merck Sharp and Dohme) (Molnupiravir) Labelling Exemption 2022.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

On 18 January 2022 the TGA granted provisional approval to Merck Sharp & Dohme (Australia) Pty Ltd for its oral COVID-19 treatment, LAGEVRIO (molnupiravir).

On 18 January 2022 the TGA granted provisional approval to Pfizer Australia Pty Ltd’s oral COVID-19 treatment nirmatrelvir + ritonavir (PAXLOVID).

The TGA determined that the two dose course of the Gamaleya Institute vaccine (Sputnik V, Russian Federation) would be 'recognised' for the purpose of establishing a traveller's vaccination status.

The TGA has issued an infringement notice, totalling $26,640, to Ezy Company Pty Ltd for alleged unlawful importation of COVID-19 rapid antigen tests and nicotine vaping products in breach of the Therapeutic Goods Act 1989.

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

Medical device safety update regarding pulse oximeters limitations, including the effect of skin pigmentation.

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

Medicines Safety Update - Information for health professionals

The new Therapeutic Goods (Medicines Advisory Statements) Specification 2021 commences 1 January 2022

On 4 January 2022 the TGA granted a further provisional determination to AstraZeneca Pty Ltd in relation to the COVID-19 treatment tixagevimab and cilgavimab (EVUSHELD).

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

The TGA has issued three infringement notices, totalling $7,992, to an individual from South Australia for allegedly advertising medicinal cannabis in breach of the Therapeutic Goods Act 1989.

The TGA regulates sunscreen products to ensure they meet the high standards for quality, safety and effectiveness set by the Australian regulatory guidelines for sunscreens.

The TGA granted provisional determination to Vaxine Pty Ltd in relation to their COVID-19 vaccine, Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2.

The TGA has issued three infringement notices totalling $39,960 for alleged unlawful advertising of medicinal cannabis in breach of the Therapeutic Goods Act 1989.

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

Medicines Safety Update - Information for health professionals

TGA has tested a number of imported products labelled as ivermectin and found that they are counterfeit

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

This is the new the legislative instrument, Therapeutic Goods (Six Monthly Report Form - Sponsor) Approval 2021 to be published on the TGA website. It is for the Six monthly report – supply of unapproved therapeutic goods by a sponsor.