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Product Regulation & Liability


The ACCC has announced two internet sweeps to identify misleading environmental and sustainability marketing claims and fake or misleading online business reviews and a separate sweep to target fake or misleading online reviews and testimonials. The sweeps are being conducted as part of the ACCC’s compliance and enforcement priorities for 2022-23 announced earlier this year, with the broad aim of identifying deceptive advertising and marketing practices related to the environment and sustainability.

The draft European Health Data Space Regulation (EHDS) is flying under the radar for some industry players. It’s just one part of a tidal wave of EU data legislation coming down the track (including the Data Act, Data Governance Act and AI Act). This means it can easily get lost in the noise. But if you take a deeper look, the EHDS has some complex repercussions for a range of players; from pharma and medtech, to hospitals, public health bodies and even big tech. And not all of it is good news.

The National Agency of Medicines, Food and Medical Technology (ANMAT) issued Disposition No. 6924/2022on 30 August 2022. The same provides some clarifications regarding the advertising, promotion and/or sponsorship of packaged food and nonalcoholic beverages containing at least one warning seal, including precautionary legends. The Disposition will take effect on the same day of its publication in the Official Gazette.

The MHRA has been accepted as a full member of three groups: the International Medical Device Regulatory Forum (IMDRF), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the US-based Medical Devices Innovation Consortium. These partnerships bolster the MHRA’s position as an influential international player in medicinal and medical device regulation and restore the MHRA’s ties with the IMDRF and ICH.

In the wake of last month’s collapse of the TerraUSD token, a broad array of regulators and government officials have attempted to introduce a legal framework around stablecoins. Last week, Senators Lummis and Gillibrand introduced a bill into the US Congress that would, among other things set requirements for the amount of backing assets stablecoin issuers would be required to hold.

In April 2022, the Health Sciences Authority published its revised Regulatory Guidelines for Software Medical Devices. It has also finalised its new Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Software, which had been released for public consultation in July to August 2021.