Articles

TGA has launched the new Early Scientific Advice service, allowing applicants to request advice on biowaiver justifications

Reminder to advertisers that first aid creams containing bufexamac cannot be advertised to Australian consumers from 18 September 2020

Criminal court proceedings have been initiated in response to alleged breaches of the Therapeutic Goods Act 1989 by Brisbane-based company HEALTHHUB247 PTY LTD and its director

TGA initiates court proceedings for alleged unlawful advertising of hyperbaric oxygen therapy chambers

The TGA has issued two infringement notices totalling $26,640 to Sydney-based company Markson Sparks for the alleged unlawful advertising of a medical device in relation to COVID-19

Medicine labels started to change in 2020 to be more consistent, highlight key information and align with medicine labels used in other countries.

Information on generic prescription medicines

The TGA is inviting consumers, health professionals, industry and other stakeholders to share their views

The TGA has issued three infringement notices for $39,960 to Melbourne-based company Yarra Valley Cleaning Co for the alleged unlawful advertising of a disinfectant product in relation to COVID-19

The TGA has issued an infringement notice for $12,600 to Western Australian-based company Medical Sales & Service for the alleged unlawful importation of anaesthetic face masks

The TGA has issued an infringement notice for the alleged unlawful importation of medical face masks in relation to COVID-19

The TGA has issued an infringement notice for the alleged unlawful importation of KN95 face masks in relation to COVID-19

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

The independent review is complete and the report now published

The TGA has issued two infringement notices, each for $12,600, to Melbourne-based companies Australian Beauty Group and VeraTemp

Adelaide woman fined $5,040 for alleged unlawful importation of cosmetic injections.

Information updated following the cessation of the Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020

The TGA has issued five infringement notices totalling $63,000 to Victoria-based company, SGC Products Pty Ltd

The TGA has issued three infringement notices totalling $39,960 to Melbourne-based company Italian Princess Coffee Brands Pty Ltd (trading as Zafe Zone)

The TGA has issued three infringement notices totalling $37,800 to Melbourne-based company Strapit Medical and Sports Supplies Pty Ltd

The Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia.

The TGA has issued three infringement notices to Brisbane clothing company Lorna Jane Pty Ltd

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