The fourth session of Vietnam’s National Assembly XV, which is taking place between 20 October 2022 and 18 November 2022, comprises meaningful discussions and the approval of draft legislation. The meeting agenda covers 14 legislative projects, only seven of which will be passed; the other seven will have to wait until the next session (June 2023).
On 4 October 2022, the Council of the European Union definitively approved the Digital Services Act, maintaining unchanged the content proposed by the European Parliament. On 5 July 2022, the European Parliament also approved the articles of the Digital Market Act still pending a final vote in the Council. The Digital Market Act and the Digital Services Act regulate the legal status of providers of intermediary services (e.g., online platforms such as marketplaces, search engines, social networks, hosting services, etc.) and thus also affect other actors (users and businesses of all sizes) interacting through their services.
On 6 October 2022, the Health Sciences Authority issued an update on products found and reported by overseas regulators to contain potent ingredients that are prohibited and briefly explained the possible side effects of the potent ingredients. The update aims to increase awareness among the local population on the safety issues of such products overseas. To better protect local consumers from harmful products that can be found overseas and online, the HSA not only conducts local surveillance, but monitors overseas enforcement actions, and updates consumers on products that may pose a threat to public health.
Roughly one year after the federal election in September 2021, the German government’s plans to legalize cannabis for recreational use have further taken shape. German Minister of Health Karl Lauterbach has introduced a document on the key points of the planned legislative changes on Wednesday, 26 October 2022. According to this document, cultivation, distribution and taxation — as well as advertisement for recreational use — of cannabis will be specifically regulated.
On 24 October 2022, the National Securities Market Commission issued a communication regarding investment recommendations made by influencers on social media. If such influencers are recognized as ‘experts’ under EU standards, they will be contacted by the CNMV and be made to comply with applicable regulations established under the framework of Regulation (EU) 596/2014 on market abuse and its Delegated Regulation (EU) 2016/958.
From 2026, pure battery electric vehicles (BEVs) must be equipped with certain levels of advanced driver-assistance systems (ADAS); otherwise, excise tax rates will be higher. The Royal Gazette has published several notifications of the Excise Department regarding BEVs recently. The Notifications have introduced the ADAS requirements as a new condition to apply lower excise tax rates on BEVs along with detailed requirements on the use of domestically manufactured batteries.
On 28 September 2022, the European Commission published its proposals for a new directive to replace the EU Product Liability Directive (85/374/EEC) (PLD). The new PLD was announced alongside a separate proposal for a directive on adapting non-contractual civil liability rules to artificial intelligence that seeks to address challenges faced by victims of AI-related damage to make claims and receive compensation, and will interact with member states’ fault-based liability regimes (AI Liability Directive). The AI Liability Directive is not intended to overlap with the PLD.
Following years of market domination by the conventional automobile industry, EV technology is now emerging as an environment-friendlier alternative, opening up various new opportunities for businesses as well as consumers all around the world. EV development permeates the whole chain of the present automotive industry, from the manufacturing and distribution sectors to subscription and ride-sharing or ride-hailing businesses. To operate an EV business in Thailand, there are certain legal concerns you need to take into account.
Under the current regulation, a Good Manufacturing Practice (GMP) certificate obtained from the Food and Drug Administration (FDA) is a voluntary requirement for local medical device manufacturers. However, manufacturers of licensed medical devices and detailed notification medical devices must provide GMP certificates from the FDA or an ISO 13485 certificate issued by one of the official Certified Bodies as part of the documents for the registration of medical devices. These certificates are not required to manufacture and notify low-risk medical devices unless they are exported and certain certificates are required by the destination countries.
EFPIA, the European Federation of Pharmaceutical Industries and Associations and IFPMA, the International Federation of Pharmaceutical Manufacturers and Associations, published at the end of September 2022 a long-awaited Note for Guidance to assist their member companies with their use of social media and digital channels. The Guidance aims to set out the areas that companies should consider when communicating on social media and other digital channels, and builds on existing guidance, including the Principles for the use of digital channels in the EFPIA Code.