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In Product Regulation & Liability

European Union: New European Medicines Agency recommendations to prevent medicine supply shortages in the pharmaceutical sector

by 6 Mins Read

The European Medicines Agency (EMA) has published a number of recommendations on good practices in securing the supply of medicinal products for human use with the aim of avoiding stockouts and reducing their possible consequences. The document states that ensuring the availability of authorized medicines in the European Union is a priority for the EMA. Among the recommendations published are the obligation to inform the national authorities of shortages of medicines as early as possible and to provide detailed information so that preventive measures can be implemented.

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In AML & Financial Services Regulatory

European Union: Europe adopts comprehensive crypto legal framework

by 5 Mins Read

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.

In Product Regulation & Liability

European Union: Pharma package – How significant are the proposals for orphan medicines?

by , and 6 Mins Read

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 The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorization and supervision of medicines.

In Trade and Foreign Investment

European Union: Creation of an EU Customs Agency and an EU Customs Data Hub?

by 2 Mins Read

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.

In Product Regulation & Liability

EU: New developments in breeding products, animal health and traceability requirements

by 4 Mins Read

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.

In AML & Financial Services Regulatory

European Union: AIFMD II state of play – preparing for change

by 2 Mins Read

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.

In Trade and Foreign Investment

European Parliament Adopts New Due Diligence Requirements to Tackle Deforestation and Forest Degradation

by 4 Mins Read

On 19 April 2023, the European Parliament adopted the final text of a new EU Regulation aimed at tackling deforestation and forest degradation (the “Deforestation Regulation”) requiring companies to undertake due diligence into the source of a wide range of commodities, including cattle, cocoa, coffee, palm-oil, rubber, soya and wood, to ensure…

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