Articles

The TGA has granted provisional approval to remdesivir ("Veklury", Gilead Sciences Pty Ltd) as the first treatment option for COVID-19.

TGA compliance and enforcement in 2019-20

Guidance to assist sponsors when using the code tables for GMP Clearance applications

Information to assist overseas manufactures who may undergo a remote Good Manufacturing Practice inspection during the COVID-19 pandemic

Pharmacies can return children's paracetamol liquid formulations to front-of-counter, but the one unit limit on sales remains in place

From 1 July 2020 medicine ads in specified media no longer require pre-approval

The TGA has issued an infringement notice for $12,600 to Sydney-based company Arborvitae Health and Wellbeing for alleged unlawful advertising in relation to COVID-19.

The TGA has issued two infringement notices totalling $25,200 to Sydney-based company Pfeffer Contracting for alleged unlawful advertising in relation to COVID-19.

The TGA has issued two infringement notices totalling $25,200 to Sydney-based company Australian Chemical Research

The TGA has issued three infringement notices totalling $7,560 to a woman based in Brisbane

There is no requirement for a medicine to display the country of origin on the label.

Medicines Safety Update article

No lasting increase in consumption following up-scheduling of low-dose products

Reminder of changes for those who advertise medicines to the public using television, radio, print media, cinema, billboards or other public displays

The TGA has commenced a review of complaints received alleging non-compliant advertising of medicinal cannabis products to the public

The International Coalition of Medicines Regulatory Authorities aims to provide healthcare professionals with important messages regarding vaccines

The International Coalition of Medicines Regulatory Authorities highlights the importance of vaccines for consumers

The TGA has issued two infringement notices to Sydney-based company Inskin Cosmedics Group Pty Ltd

Net Pharmacy fined $214,200 for alleged unlawful advertising

The TGA has issued twelve infringement notices to a Victorian-based pharmacist for alleged unlawful advertising of therapeutic goods

The TGA has issued five infringement notices to Sydney-based company Chemforce Pty Ltd

TGA taking action on sunscreens tested by AMA Laboratories

The TGA has issued four infringement notices totalling $50,400 to Cairns based company Hydrogen Technologies Pty Ltd for alleged advertising breaches including reference to COVID-19

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

The Federal Court of Australia has made orders restraining MMS Australia from advertising and supplying goods containing certain potentially dangerous substances until a further hearing next week