1-10 of 47 results
3D printing – new rules for personalised medical devices
Australia's new regulations governing personalised medical devices, including 3D-printed devices, will have significant effects. They narrow the definition of custom-made medical devices, which will continue to be given regulatory exemptions but be subject to more regulatory requirements. ...
Repurposing existing medicines – industry to have its say in reshaping Australia's regulatory future
The Therapeutics Goods Administration (the TGA) is consulting with the public and industry to potentially reform regulatory and reimbursement frameworks, to incentivise the repurposing of existing medicines. Off-label use (where a medicine is used for a disease or medical condition for which it does ...
A new rights-based approach: the Aged Care Royal Commission delivers its blueprint for radical reform
The Royal Commission into Aged Care Quality and Safety issued its Final Report, which recommends significant change through the creation of a new aged care system aimed at placing people at the centre of aged care. The recommendations are wide ranging. ...
Down-scheduling CBD and growing Australia's cannabis industry
The Therapeutics Goods Administration is proposing amendments to the Poisons Standard to permit pharmacists to sell low-dose cannabidiol (CBD) products without a prescription. Businesses intending to import, manufacture and supply cannabis products in the Australian market should monitor these developments closely. ...
Lorna Jane antivirus activewear claims don't workout
A recent set of infringement notices issued by the Therapeutic Goods Administration, including against clothing manufacturer Lorna Jane, highlights the importance of businesses carefully scrutinising all claims made about any health-related benefits of their products. We break down the elements of that case and its significance for advertising and marketing claims. ...
UK Supreme Court affirms jurisdiction to determine global FRAND terms
The UK Supreme Court's decision in Unwired Planet v Huawei confirms that disputes between organisations that own these patents, and equipment manufacturers that use the patents, can be brought and resolved on a worldwide basis in England. ...
Changes ongoing for product liability and compliance during COVID-19
Amidst increased scrutiny by the Therapeutic Goods Administration and the ACCC, Australian businesses which manufacture personal protective equipment (PPE), detergents and hand sanitiser must remain on top of changes to product laws in the healthcare space in order to avoid potential liability. ...
PBS process proving a headache for migraine medications
Challenging a PBAC decision is not straightforward. We take a look at the available options and examine the alleged delays in listing migraine treatments Emgality and Ajovy on the PBS. ...
Linklaters Insights: Novel Coronavirus - practice guide of significant commercial and legal issues
The recent outbreak of the novel coronavirus is causing disruption across greater China and the region. This cross-practice guide from our colleagues at Linklaters highlights key issues that may affect business operations in the current environment. ...
TGA guidance on the promotion of stem cells and HCT products
The Therapeutic Goods Administration has issued advertising guidance for businesses involved with stems cells and other human cell or tissue products. ...