Competent Authorities meaning

This Flowchart It outlines the competent authorities tasked with implementing UN and UK sanctions pursuant to the Sanctions and Anti-Money Laundering Act 2018 (SAMLA 2018) within the United Kingdom jurisdiction...

In this issue: Medical devices Data protection and life sciences Research and development Commercialisation Advertising of medicines Disputes and regulatory enforcement Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices Government reaction to Whitehead Review on systemic bias in UK medical devices Harriet Hanks, counsel, Sanjana Canumalla, associate, and Matt Allison, trainee, at Freshfields Bruckhaus Deringer, examine and reflect on the findings of the Whitehead Review into equity in medical devices, published on 11 March 2024. See News Analysis: UK government responds to Whitehead Review’s findings of systemic bias in UK medical devices. Guidance on content of Investigator’s Brochure for clinical investigations of medical devices issued The Medical Device Coordination Group (MDCG) has published guidance on the Investigator’s Brochure (IB) for clinical investigations of medical devices (MDCG 2024-5). The document, grounded in Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), is...

In its 25 March draft regulatory technical standards, ESMA set out essential guidance on the data that must be submitted to national competent authorities (NCAs), which will oversee the vetting of proposed acquisitions of a qualifying holding in relevant CASPs. By way of context, MiCA establishes a harmonised authorisation regime for running a CASP across the European Union and for accessing the EU passport. The overarching aim is to foster fair competition among CASPs and a more secure landscape for crypto-asset investors by verifying the robustness and reliability of authorised service providers, together with their leadership and shareholders, regardless of the member state that granted authorisation. Thereafter, any subsequent alteration to the governance or ownership of an authorised CASP stemming from a merger or acquisition must undergo prior scrutiny by the NCA supervising the target. This review is poised to materially influence how future M&A deals involving a CASP are structured, turning sound foresight and comprehension of the assessment criteria into a central task. Against this backdrop, a close examination...

In this issue: UK, EU and international regulators and bodies Authorisation, approval and supervision Accountability, culture and social governance Prudential requirements Operational resilience Financial crime and sanctions Complaints, compensation and claims management Investigations, enforcement and discipline Regulation of capital markets Regulation of derivatives Banks and mutuals Investment funds and asset management MiFID II Regulation of insurance Payment services and systems Fintech and cryptoassets Financial Services Enforcement Database Daily and weekly news alerts Intraday news alerts New and updated content Dates for your diary UK, EU and international regulators and bodies ESAs highlight role of behavioural insights in supervisory and policy work The three European Supervisory Authorities — the European Banking Authority (EBA), the European Insurance and Occupational Pensions Authority (EIOPA) and the European Securities and Markets Authority (ESMA) — have issued a joint report arising from their February 2024 workshop on integrating...

Background and introduction to SEPA After the euro was introduced in 11 EU countries in 1999, it became evident that domestic and cross-border retail payment services did not deliver comparable service levels. In September 1999, the European Central Bank (ECB) issued a report on enhancing cross-border retail payment services (the ECB 1999 Report). The report recognised that cross-border credit transfers within the euro area lagged significantly behind domestic credit transfers, even though a single currency environment called for a Single European Payment Area (SEPA). To initiate the debate and send a clear signal to the banking and payment systems industry, the Eurosystem (consisting of the ECB and the national central banks of countries that had adopted the euro) set out seven objectives for the industry to meet: Improved systems/services to be in place by 1 January 2002 Place priority on cross-border credit transfers Substantially lower the price of cross-border credit transfers Ensure settlement times are comparable for domestic and cross-border payments As...

Introduction to the MiFID II level 2 and level 3 roadmap The recast Markets in Financial Instruments Directive (Directive 2014/65/EU (MiFID II)) and the Markets in Financial Instruments Regulation (Regulation 600/2014 (MiFIR)) were published in the Official Journal of the EU on 12 June 2014 and entered into force on 2 July 2014. MiFID II and MiFIR significantly reshaped and broadened the regulatory framework that had been established by the Markets in Financial Instruments Directive 2004/39/EC (MiFID I). As amended, the majority of the Directive and the Regulation began to apply on 3 January 2018, and EU Member States had until 3 July 2017 to transpose MiFID II into domestic law. Following the MiFID II/MiFIR review, the Official Journal of the EU on 8 March 2024 set out Regulation (EU) 2024/791 amending MiFIR and Directive (EU) 2024/790 amending MiFID II. Regulation (EU) 2024/791 entered into force on 28 March 2024. Member States are required to transpose the provisions of Directive (EU) 2024/790 into national law by 29 September 2025...

1. What is the applicable legislation? The Law on Investment 2020 (Investment Law 2020), effective from 1 January 2021, is the central statute regulating foreign direct investment (FDI) in Vietnam. A number of implementing decrees have been promulgated to steer the Investment Law’s application, including the Guidelines on the implementation of the Law on Investment 2020 and Decree No. 31/2021/ND-CP, dated 26 March 2021 (Decree 31 2021), which provides guidance on several articles of the Investment Law. Together, the Investment Law and its implementing decrees set out the scope, administration and applicable licensing framework for foreign investment in Vietnam. 2. Which government or other body (or bodies) reviews foreign investments? The Ministry of Planning and Investment (MPI) is the principal regulator of FDI in Vietnam, acting mainly through its dedicated agencies, the Business Registration Agency and the Foreign Investment Agency. The MPI works with the competent line ministries for each sector and oversees the provincial Departments of Planning and Investment (each, a DPI) regarding the issuance of...