Introductory materials

This subtopic contains introductory Practice Notes on EU law:

An introduction to EU law provides an overview of the institutions, institutional framework, general principles, and enforcement of EU law with reference to the relevant provisions of EU legal sources.

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Latest EU Law News

EU Law weekly highlights—20 February 2025

This week's edition of EU Law weekly highlights includes analyses on a continuation of the EU’s efforts to modernise the judicial system, the EU General Court’s decision in EUIPO v Neoperl AG, the European Commission’s withdrawal of the proposal on standard-essential patents, the Commission’s guidelines on the definition of AI systems, the announcement of the withdrawal of the proposed EU AI Liability Directive published in the 2025 Work Programme. In addition this week, the Council of the EU approved a revised regulation on Euratom safeguards, the European Data Protection Board adopted recommendations on the 2027 World Anti-Doping Agency and a statement on age assurance for data protection compliance and created an AI enforcement task force, the Unified Patent Court published its first annual report, and the Commission endorsed the integration of the voluntary Code of Practice on Disinformation into the EU Digital Services Act framework.

European Commission issues guidelines on the definition of AI systems

EU Law analysis: The European Commission has issued long awaited comprehensive guidelines on the definition of AI systems, as established by Regulation (EU) 2024/1689 (EU AI Act). With these practical guidelines, the Commission aims to assist providers, deployers, importers, distributors of AI systems in determining whether a system constitutes an AI system within the meaning of the EU AI Act, thereby facilitating the effective application and enforcement of that Act. The definition of AI systems entered into force on 2 February 2025. Dóra Petrányi, Central Eastern Europe managing director and co-head of the Technology, Media and Communications Group, Katalin Horváth and Ian Stevens, partners at CMS, analyse the key elements of the AI system definition.

EMA updates guidance on biosimilar marketing authorisation

The European Medicines Agency (EMA) has updated its guidance on biosimilar medicines, focusing on marketing authorisation and post-market variations. Biosimilars must demonstrate high similarity to reference medicines through comprehensive comparability studies. EMA's tailored scientific advice pilot project supports biosimilar development by advising on necessary studies. The new guidance includes a Q&A on safety variations, requiring type IB variation applications for centrally authorised biosimilars within two months of changes to the reference product's information.

Imports of glass-fibre from Bahrain, Egypt and Thailand to face EU dumping probe

MLex: Imports of continuous filament glass-fibre products from Bahrain, Egypt and Thailand will face an EU dumping investigation, the European Commission said on 17 February 2025. The probe is the latest EU attempt to address dumped or unfairly subsidised exports of glass-fibre products from Chinese economic zones located in foreign countries.