Articles

The TGA, part of the Department of Health, has granted provisional determination to Moderna Australia Pty Ltd in relation to the COVID-19 Vaccine, Elasomeran

Interaction between TGA and AHPRA advertising guidelines

The TGA has issued two infringement notices totalling $26,640 to Sydney company Aidacare Pty Ltd (Aidacare).

The TGA is seriously concerned about misleading information that has been broadcast on radio stations providing a distorted picture of the safety of COVID-19 vaccines.

The TGA has implemented arrangements to facilitate the communication of information about approved COVID-19 vaccines.

The TGA has issued three infringement notices to a Queensland man for the alleged unlawful importation of a medicine containing Armodafinil.

The TGA has issued two infringement notices to a dentist from Western Australia for the alleged unlawful importation of cosmetic injectables.

The TGA has issued two infringement notices to Perth-based company V P & Associates Pty Ltd (V P & Associates), for alleged unlawful advertising of a medical device in relation to SARS-CoV-2 Human Coronavirus.

Direction Notice issued to cease advertising of therapeutic goods not entered in the ARTG

The TGA is warning sponsors not to advertise listed medicines that are not included in the ARTG with permitted indications

Peter Evans Chef Pty Ltd fined $79,920 for alleged unlawful advertising

The infringement notice relate to the alleged failure to provide information on a contact person responsible for medicine safety.

Global Therapeutics Pty Ltd has paid penalties of $119,880 in response to nine infringement notices

Updated safety advisory - rare and unusual blood clotting syndrome (thrombosis with thrombocytopenia)

TGA has recently approved wider storage and transportation conditions for the Pfizer COVID-19 vaccine in Australia

The TGA is investigating the advertising of stem cell therapies to ensure that content in the public domain complies with the Australian rules for advertising therapeutic goods.

Some rare cases of thrombosis associated with thrombocytopenia have been reported overseas following the administration of COVID-19 Vaccine AstraZeneca.

Australia’s vaccine safety and regulatory process is world class and people can be confident that vaccines approved for use are safe and effective.

New legislative instrument

It is alleged the company breached the Therapeutic Goods Act 1989 in relation to the importation of surgical face masks.

TGA has issued two infringement notices for alleged unlawful advertising of a complementary medicine cancelled from the Australian Register of Therapeutic Goods.

TGA has issued four infringement notices for alleged unlawful advertising of a complementary medicine.

The Melbourne-manufactured AstraZeneca vaccine is now available for Australians, with the TGA this evening approving the release of the first four batches.

TGA has approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.

TGA issued a fine for alleged advertising of an unlisted complementary medicine after Junction Rx failed to comply with a cease and desist notice by the set deadline.