The European Data Protection Board (EDPB) has adopted an Opinion (3/2019) on the interplay between the EU Clinical Trials Regulation (536/2014) (CTR) and the GDPR, following a request from the European Commission to review its Q&A on the topic. The CTR, which is expected to enter into force in 2020, aims to harmonise the rules for conducting clinical trials throughout the EU. It does not conta...
TechnologyThe European Commission has published an infographic on compliance with and enforcement of the GDPR since from May 2018 to January 2019. The infographic reveals some interesting statistics, including: 95,180 complaints have been made to EU national data protection authorities (DPAs) by individuals who believe their rights under the GDPR have been violated. The majority of these complaints...
TechnologyThe current absence of political resolution and the fast-approaching date for Brexit means that there is a heightened chance of a no-deal Brexit. If so, World Trade Organisation rules will govern trade with the UK so what does that mean for businesses in Ireland? Currently, the UK is part of the Single Market and the EU Customs Union. If there is a no-deal Brexit, EU law will cease to apply...
BrexitCompanies tendering for public contracts in the UK and Ireland after 29 March 2019 (or such later date if extended) will need to be aware of the changes that Brexit will bring for public procurement. While the public procurement landscape in the UK will not change dramatically in the short term, there will be some changes in practice depending on whether there is a deal or no deal. No Deal...
BrexitAs the UK is expected to leave the EU on 29 March, a number of key areas of concern have emerged in respect of health and safety protections. Stakeholders in the industry have identified serious consequences for the UK health and safety legal framework if there is a no-deal Brexit. One such area relates to the regulations governing Registration, Evaluation, Authorisation and Restriction of...
BrexitThe backstop would be a legally binding agreement between the EU and the UK that neither a hard border nor checks will be reintroduced between Northern Ireland and Ireland after the UK leaves the EU (i.e., post-Brexit). Vincent Power explains the term "backstop" which is a central feature of the Brexit negotiations and processes. What is the Backstop? Concept The backstop would be a legally...
BrexitThe current deadline for submitting a SDLT return and paying the SDLT is 30 days from the effective date of the transaction. From 1 March 2019 this time limit is being reduced to 14 days for all transactions with an "effective date" on or after 1 March 2019.
Commercial Property BelfastIt has been a busy month for cross sectoral updates with the commencement of the Consumer Protection (Regulation of Credit Servicing Firms) Act 2018. We have also seen the publication of the general scheme of the Criminal Justice (Money Laundering and Terrorist Financing)(Amendment) Bill 2019. On the European front the European Banking Authority (EBA) published a report on the results from the...
Financial RegulationOn the domestic front it has been a relatively quiet month, the Central Bank of Ireland published an update to its Q&As on Investment Firms. On the European front ESMA has updated its Q&As on Markets in Financial Instruments Directive (MiFID II) and Regulation (MiFIR). ESMA has also updated its commodity derivatives transitional transparency requirements.
Financial RegulationOn the domestic front the Financial Services and Pensions Ombudsman published legal binding decisions and the Central Bank of Ireland (CBI) issued a consultation paper on a new levy calculation methodology for insurers. On the European front a proposal for a Directive of European Parliament and of Council amending Directive 2009/138/EC (Solvency II) was published. The European Insura...
Financial RegulationOn the domestic front the Central Bank of Ireland (CBI) launched a consultation relating to new draft Anti-Money Laundering/Countering the Financing of Terrorism (AML/CFT) guidelines for the financial sector. On the European front ESMA and the EU Securities Regulators agree no-deal Brexit memorandum of understanding (MoU).
Financial RegulationOn the domestic front the Department of Finance published a report on Capital Requirements and Macroprudential policy. On the European front we have seen quite a few updates this month. The European Central Bank (ECB) published a single code of conduct for high level officials and monetary policy decisions. The ECB also published a consolidated Guide to assessments of licence applications.
Financial Regulation
