News & Analysis as of

Comment Period Regulatory Standards European Union

A&O Shearman

EBA consults on draft RTS and guidelines for third country branches under CRD IV

A&O Shearman on

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

Barnea Jaffa Lande & Co.

MiCA and Reverse Solicitation

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

Morgan Lewis - Tech & Sourcing

UK Government Publishes Green Paper on Transforming Public Procurement

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

Hogan Lovells

Net zero emissions by 2050 – new consultation on the proposed EU Climate Law

Hogan Lovells on

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

Hogan Lovells

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open!

Hogan Lovells on

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

Hogan Lovells

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

Hogan Lovells on

Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products....more

Hogan Lovells

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

Hogan Lovells on

The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

Hogan Lovells

The EMA opens a draft guideline for handling and shipping of investigational medicinal products for human use for public...

Hogan Lovells on

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

Hogan Lovells

EMA public consultation on revised policy on access to documents

Hogan Lovells on

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

Morrison & Foerster LLP

Valuing Derivatives in a Bank Bail-In

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

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