Entry into force meaning

In this issue: Intellectual property Medical devices Pharmaceuticals—regulatory framework Borderline products Commercialisation Advertising of medicines LexTalk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Chris Weekes, Technical Assistant at D Young & Co, reviews a landmark ruling on infringement of a second medical use patent, indicating how the Unified Patent Court (UPC) may handle such claims. See News Analysis: First UPC infringement decision for second medical use claims. Medical devices MLex reports that the European Commission is weighing a delay to the EU AI Act entering into application amid disputes over a code of practice for AI models, mounting industry resistance, and slippage in drafting technical standards. The move, still unconfirmed, could pause enforcement timelines to allow targeted amendments aimed at simplifying specific elements. See News Analysis: EU Commission eyes pausing AI Act’s entry into application...

In this issue: Research and development Medical devices Disputes and regulatory enforcement Competition in life sciences Pharmaceuticals—regulatory framework Daily and weekly news alerts Dates for your diary Trackers Useful information Research and development Council of EU approves EU AI Act The Council of the EU has signed off the EU AI Act. Once endorsed by the presidents of the Council and the European Parliament, the law will appear in the Official Journal of the EU and take effect 20 days later. Most rules will start to apply two years after entry into force, with certain provisions operating on a different timetable. See: LNB News 21/05/2024 9. DSIT publishes international scientific report on advanced AI safety The Department for Science, Innovation and Technology (DSIT) has issued the interim International Scientific Report on the Safety of Advanced Artificial Intelligence (AI), commissioned at the Bletchey Park AI Safety Summit in November 2023. Bringing together a...

With political and legal backdrops across key jurisdictions in flux, parties to international arbitration are choosing their seats with ever greater care, while calibrating risk accordingly. As these shifts recast procedural expectations, both parties and practitioners sensibly regard the seat named in arbitration clauses as a pivotal choice, shaped by evolving political conditions and factors such as legal certainty and stability, and perceived neutrality. Indeed, selecting the arbitral seat is among the most consequential decisions when drafting agreements, given its far‑reaching effects for the process and outcome. Chief among those effects are identifying the applicable lex arbitri (which governs procedure) and determining which courts of the chosen seat will aid enforcement of the arbitration agreement and hear any annulment, or set‑aside, proceedings once an award has issued. Several global developments are poised to influence selections of arbitral seats in 2026, including Mexico’s judicial reform and the entry into force of the revised English Arbitration Act, for many parties. Mexico's judicial reform In 2025, Mexico became the first nation...

This Practice Note sets out the essentials of Regulation (EU) 2024/2847, the EU Cyber Resilience Act (CRA): its background, timeline, aims, and how it aligns with other EU laws. For details on the CRA’s scope or core duties for economic operators, see the following Practice Notes: The EU Cyber Resilience Act—scope and classification of products The EU Cyber Resilience Act—obligations, compliance and enforcement Regulation (EU) 2024/2847, known as the CRA, is the first EU measure to set mandatory cybersecurity requirements for ‘products with digital elements’ across the EU. From December 2027, products that do not satisfy these requirements cannot be placed on the EU market. Accordingly, compliance will be crucial for market entry for both hardware and software. Manufacturers, importers and distributors will have extensive cybersecurity responsibilities and risk significant fines for non-compliance. The CRA was published in the Official Journal of the EU on 20 November 2024, entered into force on 10 December 2024, and applies in full from 11...

UK battery strategy In December 2023, the UK government set out its battery strategy, created by and delivered through the UK Battery Strategy Taskforce. Its core pillars are: Design Build Sustain The principal aim to 2030 is to establish a robust UK battery supply chain. Regulation is expected to evolve to incorporate extended producer responsibility (EPR) obligations, shifting the full cost of managing household waste to producers, in line with the ‘polluter pays principle’. Under EPR, producers are anticipated to: Achieve updated recycling targets Provide clear recyclability labelling Commitments by the UK government and the devolved administrations to implement EPR appeared in the 2018 Resource and Waste Strategy for England and the Welsh Government’s Beyond Recycling. Alongside outlining Defra’s future commitments and actions, the strategy set a long-term policy trajectory, reflected in the Environment Improvement Plan 2023 for England. For further detail, see Practice Note: Waste management plan and policies—England. Part 3 of the...

International Convention for the Prevention of Pollution from Ships 1973 as modified by the 1978 and 1997 Protocols (MARPOL) Parties As at December 2017: MARPOL or its Annexes I and II—155 parties; Annex III—147 parties; Annex IV—141 parties; Annex V—152 parties; Annex VI—89 parties. Refer to the International Maritime Organisation (IMO) status of conventions for further detail. Adopted 2 November 1973 Entry into force Annex I—2 October 1983 Annex II—6 April 1987 (major revision entered into force 1 January 2007) Annex III—1 July 1992 (major revision entered into force 1 January 2010) Annex IV—27 September 2003 Annex V—31 December 1988 Annex VI—19 May 2005 Full text MARPOL and the ‘How to do it guide’ can be purchased from the IMO in print or via an online subscription (‘Marpol on the Web’). Subject Marine pollution, marine conservation MARPOL MARPOL is the principal global treaty addressing the prevention of pollution of...