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.

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.

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).

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 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.

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.

The TGA has provisionally approved a booster dose of the Moderna COVID-19 vaccine, SPIKEVAX, for individuals 18 years and older.

Dangerous and prohibited ingredients were found in two out of every three nicotine vaping products tested by the TGA, following a joint operation conducted by ACT Health and the TGA in response to community tip-offs.

New trial (beta) tool to search the Australian Register of Therapeutic Goods (ARTG) available.

TGA grants provisional approval to Celltrion Healthcare Australia Pty Ltd for COVID-19 treatment, regdanvimab (REGKIRONA)

The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use in individuals 5 years and older.

A new Therapeutic Goods Advertising Code has been made commencing 1 January 2022, with transition period

Outcomes of the court action against Oxymed Australia Pty Ltd

The TGA has issued eight infringement notices totalling $106,560 to KL4 Pty Ltd (trading as Medcure), for the alleged importation of Ayurvedic medicines in breach of the Therapeutic Goods Act 1989 

On 1 December 2021, the TGA granted provisional approval to Roche Products Pty Ltd for the use of tocilizumab (ACTEMRA) for the treatment of COVID-19.

The TGA has issued three infringement notices totalling $7,992 to an individual for allegedly advertising ivermectin and zinc lozenges to treat COVID-19 in breach of the Therapeutic Goods Act 1989.

The TGA has issued an infringement notice for $2,664 to an individual for an alleged breach of the Therapeutic Goods Act 1989.