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Product Regulation & Liability

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With the changes to the regulation of veterinary medicines in the UK as a result of Brexit, the Veterinary Medicines Directorate has created a helpful information hub pulling together its communications on current and future regulatory changes. Access the Hub here, including useful explainers on “Application and authorisation“, “Manufacturing and distribution“, and “Pharmacovigilance“, and see below for a summary of some key points.

Through Resolution No. 706/2021, published on July 27 2021 and in effect as from that day, the Secretary of Energy created the “Liquefied Natural Gas Operators Registry” within the scope of the Undersecretariat of Hydrocarbons, dependent on the Secretary and the Ministry of Economy. The Resolution also regulated the requirements for granting LNG export permits for up to 20 years.

On 19 July 2021, the Medical Devices Branch (MDB) of the Health Sciences Authority (HSA) published its draft “Regulatory Guidelines on Risk Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS)” for comments.

The Singapore Health Sciences Authority is trialing an e-commerce surveillance tool to crack down on contraband products sold online, including illegal drugs, health products and cosmetics. The bot uses robotic process automation and artificial intelligence to trawl through online listings. It analyses information from the listings, including pictures, descriptions and profiles, to identify illegal products and listings that contain illegal or dangerous ingredients.

On 30 June 2021, the largest amendment to the Act of 12 May 2011 on Reimbursement of Medicinal Products, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices (“Reimbursement Law”) was published for public consultations until the end of August (“Draft”). The Draft is intended to enter into force within three months of its publication; however, it is difficult to predict how long the legislation process will last.

On 19 July 2021, the Medical Devices Branch (MDB) of the Health Sciences Authority (HSA) published its draft “Regulatory Guidelines on Risk Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS)” for comments.

The Singapore Food Agency (SFA) is seeking feedback for its proposed amendments to the Food Regulations. The proposed amendments delete a majority of the standards of identity currently contained in Regulations 39 to 260 of the Food Regulations, save where they have to be retained in the interest of food safety or to support public health-related policies. The proposed changes are expected to come into effect in April 2022.

On 12 June 2021, the Singapore Food Authority published a media release in relation to a recall of several Eat Real Puff products, following a similar recall of the same products by the United Kingdom Food Standards Authority. Separately, on 25 June 2021, the Consumer Product Safety Office published a media release in relation to a voluntary recall of the Cotton On Kids Projector Light by the Cotton On Group.