The Government of Canada has established additional avenues to administer and enforce Canadian sanctions laws. Specifically, the government is relying on the existing legislative framework under the Proceeds of Crime, Money Laundering, and Terrorist Financing Act (PCMLTFA) and its administrative agency, the Financial Transactions and Reports Analysis Centre of Canada (FINTRAC) alongside the Canada Border Services Agency (CBSA) to establish a sanctions civil enforcement regime in the form of mandatory reporting on suspected sanctions evasion for prescribed entities, importers, exporters and those financing import/export transactions.
Our updated Regulatory Risk Management Risk Radar analyzes the most pressing regulatory risks that FIs need to consider in 2024. In this year’s edition, we examined how these risks impact business decision-making. We also examine recent and upcoming developments, and how they continue to shape the roles and responsibilities of FIs related to regulatory risk management.
In an article published in Compliance & Risk Journal, John Bracken and Lorren Martin explore the issue of non-financial misconduct in UK financial services firms, and how best to manage the potential risks.
On 20 June 2024, a new ordinance of the Austrian minister of health regarding the stockpiling of medicinal products for human use was published in the Austrian Federal Law Gazette (BGBl II 161/2024). The purpose of this ordinance is to take preventive measures avoiding supply bottlenecks for medicinal products in Austria, ensuring sufficient supply of medicinal products at all times for the Austrian population.
On 5 July 2024, the Argentine Central Bank issued Communication “A” 8059, introducing amendments applicable to the payment of interest on commercial and financial debt between related counterparties, to the extent that certain requirements set forth in the regulation are met.
On 8 July, the Singapore Food Agency (SFA) approved 16 insect species for human consumption and animal feed, including various species of crickets, mealworms and moths. The SFA has also put in place requirements that importers must adhere to for importing insects and insect products.
On 15 May 2024, the Government officially issued the new Decree No. 52/2024/ND-CP to regulate cashless payments (“Decree No. 52”). Decree No. 52 took effect from 1 July 2024 and replaced the previous Decree No. 101/2012/ND-CP on cashless payments, as amended from time to time. Among other things, Decree No. 52 sets forth regulations on opening and using payment accounts, cashless payment services and intermediary payment services (IPS).
Under the recently published Act XXIX of 2024 amending certain acts concerning the operation of the State, as of 1 January 2025, certain decisions on named patient reimbursement of medicinal products will be made by a newly created public benefit foundation in addition to the NEAK. Further, starting from 1 January 2026, the operator of the National eHealth Infrastructure (EESZT) may give access to the stored data for the purpose of AI development.
On 3 May 2024, the European Medicines Agency (EMA) published new Q&As for applicants, marketing authorization holders of medicinal products, and notified bodies on the implementation of the EU Regulations on medical devices and in vitro diagnostic medical devices (i.e., EU Regulations 2017/745 and 2017/746). The new Q&As are based on the experience gained from the application of the regulations and the specific cases encountered so far, and aim at providing practical considerations on the relevant implementation, with particular reference to those products that consist of a combination of medicinal products with medical devices.
The EU has approved the new Regulation on Substances of Human Origin (SoHO) aimed at improving the safety and quality of blood, tissues and cells used in health care and facilitating the circulation of these substances within the EU. The new regulation broadens the scope of SoHO to human breast milk and intestinal microbiota and covers a variety of activities, ranging from registration and testing of donors, collection and processing to human application and clinical outcome monitoring of substances of human origin.