Consumer protection

This overview is a guide to the content within the Consumer protection (EU Law) subtopic, with links to the appropriate materials. This subtopic examines EU regulations and directives which protect EU consumers and which should be considered in business-to-consumer (B2C) relationships.

Key EU consumer legislation

Prior to contracting or trading with EU consumers, it is important for traders to be aware of the EU legislation that governs B2C relationships. Practice Note: Key EU consumer legislation—summary sets out a brief description of key EU consumer legislation that businesses should consider when dealing with consumers. It covers the core legislation relevant when trading or contracting with consumers within the EU and other key legislation applicable to the B2C relationships in the context of advertising and labelling, data protection, e-commerce, payment, product liability and safety, provision of services, and consumer disputes and enforcement. It also covers sector-specific consumer legislation such as travel and transport. This Practice Note does not cover environmental and life sciences legislation.

To keep up to date with the latest changes in key EU consumer legislation, Practice Note: EU consumer protection—tracker tracks EU commercial legislation

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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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