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The European Banking Authority (EBA) has published three consultation papers under Directive 2013/36 (CRD IV), as amended by Directive 2024/169 (CRD VI), relating to the regulatory requirements for third country branches...more
Non-EU or non-MiCA compliant entities that want to offer or provide crypto-asset services to clients in the EU must be aware of the newly drafted guidelines from the European Securities and Markets Authority (ESMA). The...more
The UK government published a Green Paper on December 15 that includes proposals to shape the future of public procurement in the United Kingdom by speeding up and simplifying public sector procurement processes....more
The European Commission announced recently that it seeks feedback on proposals to adopt new regulations which establish the framework for achieving EU-wide 'climate neutrality' by reducing greenhouse gas emissions to net zero...more
On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more
Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products....more
The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more
On 23 May 2018, the European Medicine Agency (EMA) launched a public consultation for a draft guideline concerning the responsibilities of trial sponsors for handling and shipping of investigational medicinal products for...more
The EMA has launched a public consultation on its draft new Policy/0043 on access to documents. The document describes the EMA’s approach in balancing public and private interests involved in requests for access to documents...more
Under the EU’s Bank Recovery and Resolution Directive (“BRRD”), one of the key powers given to national resolution authorities is the ability to impose losses on, or “bail-in”, certain financial liabilities of the failing...more