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On 14.12.2024, the European Commission published Guidance for Applicants in the context of authorisation procedures for veterinary medicinal products under Regulation (EU) 2019/6 (“Veterinary Medicinal Products Regulation”) in the Official Journal of the EU.

In the legislative process, the European Council has recently presented the compromise text reacht in trilogue negotiations of the Right to Repair Directive. While some of the European Parliament’s amendments have been adopted, the Council has moved closer to the Commission’s original proposal in key aspects.

The Minister of Forestry, Fisheries and the Environment (the “Minister”) published the Draft Guideline and Toolkit for the Determinati on of Extended Producer Responsibility Fees (GN 4308 of 2 February 2024) in terms of sections 72 and 73 of the National Environmental Management Waste Act, 2008 (“NEMWA”) (the “Draft EPR Guideline”) on 25 August, inviting public comment.

On 13.07.2023, the European Commission published its proposal for a regulation on the circular design of vehicles and the disposal of end-of-life vehicles, which is intended to replace Directive 2000/53/EC of 18.09.2000 (so-called End-of-Life Vehicles Directive) and Directive 2005/64/EC of 26.10.2005 (so-called 3R type-approval Directive).

Digitalisation will be the guiding theme for the life science sector in 2024. There will be a series of legislative initiatives in 2024, not only at European level but also from national legislators, with the aim of driving forward both the development and application of digital solutions in the healthcare sector. In addition, improving the research landscape in Germany is a central concern in the legislative activities.

Developments in product-related civil law and product-related competition law will continue to be of interest in 2024. In particular, some legislative projects are about to be finalised, meaning that the industry will probably have more clarity about the future legal situation in terms of content and timeline in the course of 2024.

2024 could be the year of regulation of smart and digital products. This is because the EU players already agreed on a Cyber Resilience Act and an AI Act at the end of 2023, meaning that they can be expected to be adopted in 2024. Negotiations on the new EU Product Liability Directive, which will replace Directive 85/374/EEC and comprehensively reform product liability law, are also in the “hot phase”; it is therefore not unlikely that the new EU Product Liability Directive will be adopted in 2024.

The year 2024 will be characterised by numerous major projects at EU level in all areas of product-related regulation, some of which will be concluded, some of which will make significant progress and some of which will only be initiated. In terms of content, we can expect sector-specific regulations, for example for batteries, textiles and vehicles, as well as numerous cross-sectoral legal acts. These include, in particular, chemicals legislation, ecodesign requirements, “green claims” and the planned right to repair.