After several years of intense debate, during its session on 16 May 2023, the European Council finally approved the Regulation on Markets in Crypto-Assets (MiCA). MiCA brings a substantial change to the EU regulatory landscape, creating a harmonized regime in terms of issuance and the provision of services in relation to crypto-assets, consistent with the international reach of this technology.
On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation. The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorization and supervision of medicines.
On 17 May 2023, the European Commission published a set of proposals that, according to the Commission, constitute the “most ambitious and comprehensive reform of the EU Customs Union since its establishment in 1968.”
Introduction of an EU Customs Agency is becoming more and more tangible. This idea of a “European Customs Agency” was first proposed on 31 March 2022 by the “Wise Persons Group on Challenges Facing the Customs Union”. More recently, on 28 February 2023, during the 62nd Plenary Meeting of the Trade Contact Group set up by the European Commission, the creation of an EU Customs Authority was once again discussed alongside the introduction of an EU Customs Data Hub and further simplification of customs processes.
On 10 May 2023 the Council of the European Union and European Parliament signed the regulation implementing the EU Carbon Border Adjustment Mechanism (CBAM). CBAM will enter into force twenty days after it is published in the Official Journal of the European Union.
Baker McKenzie’s Sanctions Blog published the alert titled EU discusses eleventh package of EU sanctions against Russia on 12 May 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
The new Delegated Regulation (EU) 2023/647 has amended the former Delegated Regulation (EU) 2020/686, which in turn complemented Regulation (EU) 2016/429, on the prevention and control of transmissible animal diseases, animal health requirements and traceability of animal reproductive products. The new Regulation complements the rules laid down in the original regulation as regards animal health issues of traceability and certification of movements of captive breeding products of terrestrial animals. Furthermore, the main objective of the regulation is to unify the different regulations applicable on this matter in order to improve their application and to avoid duplication or cross-references.
On 25 November 2021, the European Commission published its long-awaited proposals to amend the Alternative Investment Fund Managers Directive (AIFMD), along with changes proposed to the UCITS Directive and ELTIF Regulation (AIFMD II). The Commission’s proposals follow ESMA’s August 2020 letter of recommendations for changes that could be made to the AIFMD framework. Tripartite negotiations on AIFMD II are ongoing, following agreement by the Council of the EU on its general approach in June 2022, and adoption by the European Parliament’s Economic and Monetary Affairs Committee of its negotiating position in January 2023.
On 19 April 2023, the European Parliament adopted the final text of a new EU Regulation aimed at tackling deforestation…
On 26 April 2023, the European Commission finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical Strategy for Europe, and its aim is to make medicines more available, accessible and affordable whilst at the same time supporting innovation and boosting the competitiveness of the EU pharmaceutical industry.