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949 result(s) found, displaying 1 to 25
- COVID-19 vaccine safety report - 21-09-2023COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- COVID-19 vaccine: JanssenNewsOn 28 August 2023, Janssen-Cilag Pty Ltd voluntarily cancelled COVID-19 VACCINE JANSSEN from the Australian Register of Therapeutic Goods (ARTG).
- Naturally Elevated Pty Ltd and an individual fined $138,600 for alleged unlawful advertising of medicinal cannabisMedia releasesWe have issued infringement notices to the company Naturally Elevated Pty Ltd and an individual for the alleged unlawful advertising of medicinal cannabis on websites and social media pages.
- Product Information safety updates - September 2023Safety updatesMedicines Safety Update - Information for health professionals
- Medical devices vigilance program pilotNewsWe are starting a new medical device pilot program to support medical device sponsors to comply with their ongoing post-market surveillance responsibilities.
- Therapeutic Goods (Mercury - Form for Application to Import or Export) Approval 2023NoticesThis instrument is made under subregulation 10JD(4) of the Therapeutic Goods Regulations 1990.
- COVID-19 vaccine safety report - 07-09-2023COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- Changes to the regulation of sports supplements in medicinal dosage formsNewsFrom 30 November 2023, some sports supplements will be regulated as therapeutic goods and must be included in the Australian Register of Therapeutic Goods (ARTG).
- Scam alertNewsWe are aware that a small number of people have received calls from scammers impersonating the TGA.
- Changes to choline salicylate access to start from 1 October 2023NewsFind out about changes to choline salicylate access, starting from October 2023.
- Post-market review of facemasks closedNewsThe COVID-19 pandemic post-market review of facemasks is now finished.
- Product Information safety updates - August 2023Safety updatesMedicines Safety Update - Information for health professionals
- TGA seizes 40,000 vapes as part of multi-agency operation in QueenslandMedia releasesOn 29 August 2023, the TGA executed multiple warrants on storage units and residences in Brisbane and seized over 40,000 vaping products with an estimated street value of over $1.2 million
- Product Information inserts are no longer required for injectable medicines administered by health professionalsNewsFind out how Product Information inserts won’t be required in the packaging of injectable medicines, given by health professionals, starting from September 2023.
- Nius Development Pty Ltd fined $26,640 for allegedly importing unapproved cosmetic injectable productsMedia releasesWe have issued infringement notices for $26,640 to Nius Development Pty Ltd for the alleged unlawful import of unapproved cosmetic injectable products.
- EmpireLabz Australia Pty Ltd fined $115,500 for alleged unlawful advertising and supply of sport supplementsMedia releasesThe TGA has issued 7 infringement notices totalling $115,500 to the company for the alleged unlawful advertising and supply of sport supplement products containing banned substances.
- COVID-19 vaccine safety report - 24-08-2023COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- New guidance published on manufacturer evidence for IVD medical devicesNewsTo help sponsors and manufacturers transition to new manufacturer evidence.
- Phase out of ISO 13485 certificates for IVD medical devicesNewsTransition period for accepting ISO 13485 ends 26 May 2023.
- New reporting requirements for medicine shortagesNewsCompanies supplying medicines in Australia will be required to provide additional information if their products go into shortage.
- Update to listed medicine ingredients in July 2023NoticesFind out how listed medicine ingredients, and requirements for their use, have been updated in the latest Therapeutic Goods (Permissible Ingredients) Determination.
- COVID-19 vaccine: SPIKEVAX (elasomeran)NewsThe TGA approved Moderna Australia’s application to transition its COVID-19 vaccine, SPIKEVAX (elasomeran), from provisional to full registration.
- COVID-19 vaccine safety report - 10-08-2023COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
- SME Assist workshops and eventsNewsTGA SME Assist presents "Meeting your Obligations" a free workshop aimed at beginners who are unfamiliar with therapeutic goods regulation.
- COVID-19 vaccine safety report - 27-07-2023COVID-19 vaccine safety reportsInformation about the TGA's safety monitoring of COVID-19 vaccines.
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