EU immigration

EU immigration

This subtopic contains the following guidance on EU level rules relating to immigration:

Practice Note: EU immigration policy—Key immigration Directives provides a high level overview of the EU immigration policy, with a look at the key Directives enacted since the EU was given powers to legislate on this matter in the late 90s. This overview examines the scope of the legislation, the conditions laid down for admission and residence for Third Country Nationals (TCNs), rights to equal treatment vested in TCNs, security of residence for TCN and family members as well as a brief look at the facilitation afforded by these Directives towards

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Latest EU Law News

EFPIA leads healthcare associations in challenging ECHA's PFAS restriction assessment approach

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and eight other healthcare associations have raised concerns that the European Chemicals Agency (ECHA) will not conduct individual sector assessments for medicines as part of its proposed universal restriction on PFAS chemicals. While the healthcare sector remains within the restriction's scope, ECHA indicated that 'other medical applications' covering medicinal products and manufacturing will not be individually assessed during preparation of final opinions by the Risk Assessment Committee and Socio-Economic Analysis Committee. The associations argue this approach prevents the European Commission from understanding public and animal health impacts and urge ECHA to ensure dedicated assessment of the healthcare sector within the PFAS restriction process.

European Commission adopts delegated regulation on EMIR active account requirements

The European Commission has adopted a delegated regulation supplementing article Article 7a of the European Market Infrastructure Regulation (Regulation (EU) No 648/2012) (EMIR) (as introduced by Regulation (EU 2024/2987) (EMIR 3)) containing regulatory technical standards (RTS) for active account requirements. The delegated regulation implements EMIR 3 provisions intended to reduce financial stability risks from EU exposure to third-country central counterparties by requiring certain counterparties to maintain operational active accounts at EU CCPs. The rules establish operational conditions including IT connectivity and stress testing requirements, representativeness obligations for euro and Polish zloty interest rate derivatives, and six-monthly reporting requirements to competent authorities.

Commission publishes updated clinical trials guidance package

The European Commission's Directorate-General for Health and Food Safety has published a comprehensive package of updated clinical trials guidance documents, all endorsed by the Clinical Trials Coordination and Advisory Group (CTAG) on 15 October 2025. The package includes new recommendations on criteria for selecting a reporting Member State under Article 85(2)(c) of the Clinical Trials Regulation, establishing a workshare criterion when proposed reporting Member States decline the role, which occurs in approximately 30% of applications. The Commission has updated its recommendation paper on decentralised elements in clinical trials (Version 02), superseding the December 2022 version, with revised national provision overviews and guidance on informed consent, investigational medicinal product delivery, and remote monitoring. A new recommendation paper addresses frequent issues identified during Part I and Part II assessments, based on feedback from national competent authorities and ethics committees, covering investigational medicinal product dossiers, protocols, and safety reporting. The package also includes revised guidance on auxiliary medicinal products, effective 1 December 2025 for new applications, featuring an updated classification system distinguishing between authorised, modified authorised, and unauthorised auxiliary medicinal products with corresponding application and safety reporting requirements.

Commission opens consultation on draft EU design IP procedures regulation

The European Commission has published a draft delegated regulation establishing rules for EU design-related intellectual property procedures managed by the European Union Intellectual Property Office. The regulation supplements Regulation (EC) No 6/2002 and replaces the existing Commission Implementing Regulation (EC) No 2245/2002, as required by Regulation 2024/2822 to align Regulation (EC) No 6/2002 with Articles 290 and 291 of the Treaty on the Functioning of the EU. The Commission plans to adopt the regulation in the first quarter of 2026. The consultation period runs from 29 October 2025 to 26 November 2025.