ASIC is coming for your responsible managers
A key obligation of an AFSL holder is to maintain the competence to provide the financial services covered by its licence.[1] ASIC refers to this obligation as the “organisational competence obligation.” In order to comply with this obligation, Regulatory Guide 105: Licensing: Organisational competence (RG 105) provides that the licence holder must nominate Responsible Managers […]
ReadmoreHigher Education Research Commercialisation Intellectual Property Framework – a tool to increase collaboration and partnerships between industry and universities
Most Australians are aware of the strength and quality of our nation’s research sector, particularly in fields such as life sciences and medical research. Never has this been more evident that during the COVID-19 pandemic, when Australians could, quite rightly, be proud of the role that Australians researchers played in the global efforts to develop […]
ReadmoreFMCG Express | September 2022 Edition
In the latest edition of FMCG Express, Partner Breanna Davies and the Gadens team bring you the latest developments in the consumer, retail and hospitality sectors in Australia. In this issue, our team delves into the issues surrounding positive obligations to eliminate sexual harassment in the workplace; risks and solutions when dealing with commercial contracts […]
ReadmoreAdvertising under the influencers and changes to the TGA Code: Are you ready for 1 July 2022?
We are in a transition period in the world of therapeutic goods advertisements (TG Advertisements). Currently, TG Advertisements must comply with either the Therapeutic Goods Advertising Code (No.2) 2018 (Cth) (Former Code) or the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Cth) (New Code). The transition period ends on 30 June 2022. A caveat […]
ReadmoreCOVID-19 | Navigating the vaccination minefield – what employers need to know
Revised as at 17 September 2021 Following our recent webinar, ‘Navigating the vaccination minefield – what employers need to know’, in this easy-to-download PDF we have put together a list of answers to some of the most commonly asked questions for employers navigating the COVID-19 vaccination minefield. This guide will serve as an essential tool […]
Readmore‘A reasonable and commercial construction?’ Patent time extensions after Ono Pharmaceuticals
The Federal Court of Australia has ordered the Commissioner of Patents to grant Bristol Myer Squibb (BMS) a patent term extension (PTE) for cancer drug Opdivo until 2031, providing certainty to industry around Australia’s intellectual property regime. Background BMS and Ono Pharmaceutical sought judicial review by the Federal Court of Australia after the Australian Patents […]
ReadmoreCOVID-19 | TGA updates guidance for advertising of COVID-19 vaccines to Australian public
In February 2021, we provided an update on the guidance issued by the Therapeutic Goods Administration (TGA) regarding the advertising of COVID-19 vaccines to the Australian public. That update is available here: COVID-19 | TGA issues guidance for advertising of COVID-19 vaccines to Australian public. Under the previous guidance, advertisers were restricted to republishing materials […]
ReadmoreNew wave of litigation expected to hit Australia’s eroding shoreline
Last week, the Federal Court of Australia embarked on what is predicted to be a landmark decision, in the matter of AGL v Greenpeace Australia Pacific (Greenpeace). The case involves allegations by AGL that Greenpeace infringed its trademark rights and copyright when it featured AGL’s logo in a recent ad campaign, designed to pressure the […]
ReadmoreFMCG Express | May 2021 Edition
2021 certainly started with a bang; we are seeing a significant boost in appetite for advice right across our FMCG client base, including a lot of M&A activity, and we are excited to see how the year ahead unfolds. In the May 2021 edition of FMCG Express, editor Hazel McDwyer and the Gadens team provide […]
ReadmoreTimely reminder for companies to lodge their financial reports
Recent prosecutions and convictions obtained by the corporate regulator serve as a timely reminder for companies of the importance of lodging financial reports. The Australian Securities and Investments Commission (ASIC) recently prosecuted and obtained convictions against three companies for failing to lodge annual financial reports with ASIC within the specified period after the end of […]
ReadmoreWhen software delivers a therapeutic benefit: regulation of digital therapeutics
Digital therapeutics are defined as evidence-based therapeutic interventions that are driven by software programs to prevent, manage or treat a medical disorder or disease. As medical technological innovation continues at pace, more software applications and devices are under development to inform, drive or replace clinical decisions or directly provide therapy to a patient. The Therapeutic […]
ReadmoreCOVID-19 | Medicines dispensing emergency measures extended
At the commencement of the COVID-19 pandemic, the Australian Government introduced a range of measures to take the pressure off Australia’s health care system, such as the introduction of TeleHealth and E-Prescribing. Another measure was to extend the Continued Dispensing rules to enable pharmacists to supply medicines without prescription to certain patients. These emergency measures […]
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