TGA
The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued two infringement notices totalling $26,640 to Perth-based company V P & Associates Pty Ltd (V P & Associates), for alleged unlawful advertising of a medical device marketed for the prevention of “SARS-CoV-2 Human Coronavirus”.
V P & Associates allegedly advertised, on the company’s website, a plant-based nasal and oral solution called Liquim that claimed it has 99.9% effectiveness against SARS-CoV-2 Human Coronavirus. The product had not been approved for inclusion in the Australian Register of Therapeutic Goods (ARTG) as a preventative for SARS-CoV-2 Human Coronavirus.
The Therapeutic Goods Act 1989 (the Act), prohibits advertising to the public for therapeutic goods that are not entered in the ARTG (unless a specific exemption, approval or authority applies). The inclusion of products in the ARTG through the regulatory approval process is an important safeguard to ensure the safety
The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued three infringement notices totalling $7,992 to a Queensland man,.
TGA
The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued two infringement notices totalling $5,328 to a dentist from Western Australia, for the alleged unlawful importation of medical devices.
The dentist allegedly imported syringes containing hyaluronic acid that were not included in the Australian Register of Therapeutic Goods (ARTG).
Under the Therapeutic Goods Act 1989 (the Act), therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia (unless a specific exemption, approval or authority applies).
Pre-filled syringes containing hyaluronic acid are medical devices used to change how parts of the skin look, and are often used to reduce lines and wrinkles on the face.
Sandoz Australia, the supplier of the drug, recently asked the PBS to increase the price of the patches because the listed cost was no longer sustainable due to manufacturing costs increasing during the Covid-19 pandemic. When the request was refused, Sandoz announced it had requested the products be delisted from the PBS from June, a move that would make the patches available via private prescription only meaning patients would have to pay full price.
It prompted the Australasian Menopause Society, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, and the Endocrine Society of Australia to write a joint letter to the health minister Greg Hunt to urgently reconsider and to work with Sandoz to strike an agreement.
Employing precision-moulding and die-cutting processes, Porvair Sciences can efficiently convert hydrophilic Vyon porous plastic into discs and annular-shaped parts to tightly toleranced specifications. These versatile approaches enable Porvair to offer high-performing, precisely manufactured products in diameters ranging from 3 mm to 1 m using any of its hydrophilic Vyon materials options, up to 4.75 mm thick. Hydrophilically treated Vyon materials have exceptional absorption and fluid-transfer properties and therefore, can be implemented as an efficient absorber with their instantaneous wetting properties. Due to the tortuous path of its porous structure, hydrophilic Vyon can efficiently filter and trap contaminants while allowing for effective delivery of drugs in various forms, such as solutions, suspensions, and emulsions. It has been tested to the most rigorous of Unites States Pharmacopeia classes and certified with a Class VI approval.