Advertising - testimonials and endorsements. This is a new TGA guidance document that explains the difference between testimonials and endorsements, and which types of each are permitted. For example, testimonials: Testimonials made by anyone engaged in the production, marketing or supply of the advertised therapeutic good, along with others as described in the Code, are not permitted. Advertisements for therapeutic goods must not contain a testimonial from anyone who has received ‘valuable consideration’ for making the testimonial or for marketing the goods. This includes social media influencers, bloggers and brand ambassadors. What is valuable consideration? This guidance provides many hypothetical examples of testimonials and endorsements and shows which are compliant and which are not permitted. A must-read guidance. Read it here.
Training course in advertising: RFA offers a one hour training course on advertising. Information is here.
Risks of intentional self-poisoning with paracetamol. (TGA) has commissioned a report on the risks of self-harm from intentional paracetamol misuse. Source: TGA
Poisons schedules: final decisions including chromates and chromium trioxide. Source: TGA
Public consultation on proposed amendments to the Poisons Standard
Item 1.1 - Cetirizine
Item 1.2 - Budesonide
Item 1.3 - MDMA
Item 1.4 - Psilocybine
Item 1.5 - Apronal (allylisopropylacetylurea)
Item 2.1 - Helional
Item 2.2 - Hydroxypinacolone retinoate
Item 2.3 - MDMA and MDA
Item 3.1 - Dichloromethane (methylene chloride)
Item 3.2 – Ipflufenoquin
Swisse Beauty Collagen Glow Gummies. Source: TGA
Medtronic Implantable Defibrillators - Implant Hazard - software update required. Source: TGA
Multiple Sunscreens Recalled - Low levels of benzene detected. Updated list of products here.
Comparable overseas bodies for complementary medicines. An updated list is here.
Export of medicines. A guidance document including recent updates. Source: TGA
15 infringement notices totally $39,960 issued to a NSW person for alleged unlawful importation of ivermectin and doxycycline. 2,500 ivermectin tablets and nearly 10,000 doxycycline capsules were imported over the course of one month, far exceeding what is allowable under the Personal Importation Scheme. Source: TGA
FatBlaster Max (AUST L 348163) cancelled from the Australian Register of Therapeutic Goods. The TGA considers that the name 'FatBlaster', would be understood to represent that the medicine causes loss of body fat and therefore weight loss, neither of which are indications listed for the product. Cat Media is appealing. Source: TGA
Infringement notice of $2,664 issued to a Sydney based individual for alleged unlawful importation of unregistered anaesthetic products. The individual was previously a general practitioner but surrendered their registration in 2019 and did not have approval or authority to import the goods into Australia. Source: TGA
Aussiewhip Pty Ltd fined $39,960 for alleged unlawful advertising of disposable nicotine vaping products which are prescription-only medicines and must only be dispensed by pharmacies to consumers who hold a valid prescription. After being contacted by the TGA the company shut down the website but reinstated the content on a new website. Source: TGA
Three infringement notices totalling $39,960 issued to New South Wales company Khazanah Nasional Pty Ltd for alleged unlawful advertising of disposable liquid nicotine vaping products. Source: TGA
TMF Cosmeceuticals Pty Ltd fined $26,640 for alleged unlawful importation of ivermectin. Source: TGA
FuturePro convicted and its director was convicted and fined $25,000 for unlawful conduct relating to alternative medicines. In particular for the banned substance Sanguinaria canadensis (bloodroot) which is used to make black salve, a corrosive topical paste, and unregistered gumby gumby. Claims were being made for the prevention and treatment of cancer. Source: TGA
Individual fined $2,664 for unlawful importation of nicotine vaping pods. Source: TGA
NSW Health has seized more than $1 million worth of illegal e-cigarettes and liquids containing nicotine since January 2022. Source NSW Health
Approved COVID-19 rapid antigen self-tests. This list is regularly updates by the TGA. Source: TGA
Unique device identification. A TGA presentation of “real world experiences”. Source: TGA
Personalised medical device framework. Overview of medical device regulations. A TGA presentation available here.
Medical devices or surfaces with anti-viral or anti-microbial claims. A TGA presentation on what anti-viral claims can be made, evidence required, advertising requirements and documentation required. Source: TGA
Regulation of software based medical devices. A factsheet for digital mental health: Software based medical devices is here.