EU judicial system

This subtopic contains a range of resources on the EU judicial system and the interpretation and enforcement of EU law.

A fundamental principle of EU law is the supremacy of EU law, also known as the primacy of EU law. Under this principle in the event of a conflict between EU law and national law, EU law is supreme and has primacy, irrespective of the source, status or date of the national law in question. Thus, EU law is also supreme over domestic constitutional provisions in the event of any conflict, but this has not been established without some concerns being raised by constitutional courts within the Member States. As originally drafted, the EU Treaties did not include any provision by which the supremacy of EU law was guaranteed. The Court of Justice has played a fundamental role in applying this principle and ensuring the uniform application of EU law across the Member States. For further reading, see Practice Note: The supremacy of EU law.

The European Commission’s role as 'Guardian of the Treaties' is to control the correct application of EU law across EU Member

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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.

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