Articles

The TGA has provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron BA.1) for use as a booster dose in adults 18 years and over.

Temporary update to the target timeframes for assessment of Compliance Verification (CV) GMP Clearance applications

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

On 19 October 2022, the TGA provisionally approved Moderna's COVID-19 vaccine, SPIKEVAX (elasomeran), for use as a booster dose in individuals aged 12 years and older.

Inspire Cosmetology Pty Ltd fined $26,640 for alleged unlawful import of cosmetic injectable products

NSW medical practitioner fined for allegedly illegally importing prescription medicines

The Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.

The TGA has issued two infringement notices totalling $5,328 to a Queensland-based individual for the alleged unlawful use of a prohibited representation and endorsement in advertising a listed complementary medicine.

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

Update to GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic.

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.

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

Medicines Safety Update - Information for health professionals

Tell us your experience using of the beta Database of Adverse Event Notifications (DAEN) - medicines.

In a bushfire or other natural disaster you might need emergency access to an important medicine. Here are some tips on how to plan ahead.

The TGA has granted a provisional determination to Moderna Australia Pty Ltd’s bivalent COVID-19 vaccine candidate: elasomeran and davesomeran (SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4/BA.5)

The TGA has provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, COMIRNATY (tozinameran), for children aged 6 months to less than 5 years

Best Body Industries Pty Ltd fined for alleged unlawful advertising of sports supplements

The TGA has issued a direction notice to MDNE Enterprises Pty Ltd to cease promoting the use and supply of nicotine vaping products to the Australian public.

Direction and infringement notices given to MDNE Enterprises Pty Ltd for alleged unlawful advertising of nicotine vaping products

Fines totalling $972,360 given to three medicinal cannabis companies for alleged unlawful advertising

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

JSHealth Vitamins Pty Ltd fined for alleged unlawful advertising

The TGA has provisionally approved Pfizer's COVID-19 vaccine, COMIRNATY (tozinameran) for use as a booster dose in individuals 5 years to 11 years.