Regulated facility meaning

In this issue: Competition in life sciences Medical devices Research and development Commercialisation Disputes and regulatory enforcement Daily and weekly news alerts New and updated content Trackers Useful information Competition in life sciences Teva, Cephalon cannot overturn €60m fine in pay‑for‑delay case Law360, London: On 23 October 2025, Europe’s highest court confirmed a €60.5m penalty against Teva and its acquired business Cephalon, holding that their pay‑for‑delay accord curtailed competition by preventing a lower‑priced generic for a blockbuster narcolepsy medicine from reaching the market. See: Teva, Cephalon cannot overturn €60m fine in pay‑for‑delay case. Judgment Alert: Teva Pharmaceutical Industries Ltd v Cephalon Inc, ECLI:EU:C:2025:825 The Court of Justice of the European Union (Fourth Chamber) rejected the appeal brought by Teva Pharmaceutical Industries Ltd and Cephalon Inc against the General Court’s ruling, which had refused their application to annul the Commission’s Decision. The Commission had concluded the parties infringed Article 101 of the Treaty on the...

The planned reforms aim to strengthen the appeal of the UK’s capital markets. They carry notable consequences for IPOs and secondary equity raises where securities will be admitted to trading on a UK regulated market, such as the LSE’s Main Market, or on a UK multilateral trading facility (MTF), such as AIM. Market rulebooks set the eligibility thresholds, admission conditions and ongoing duties once on a primary MTF, and for issuers of debt securities on a UK regulated market. Background The consultation follows the adoption earlier this year of the Public Offers and Admission to Trading Regulations, which created the framework for the planned overhaul of the UK prospectus regime. In particular, it is proposed that: offering securities to the public will be barred unless an exemption applies, with a key exemption where the offer is conditional on the securities being admitted to trading on a UK‑regulated market or a primary MTF the liability threshold for investor claims concerning certain forward-looking statements (described as...

In this issue: UK, EU and international regulators and bodies Financial crime and sanctions Consumer protection Complaints, compensation and claims management Investigations, enforcement and discipline Regulation of capital markets Packaged Retail and Insurance-based Investment Products (PRIIPs) Dispute resolution for financial services lawyers Regulation of derivatives Sustainable finance and ESG Banks and mutuals Investment funds and asset management UK MiFID II EU MiFID II Consumer credit, mortgage and home finance Payment services and systems Fintech and cryptoassets Regulation of AI in FS LexTalk®Financial Services: a Lexis®Nexis community Financial Services Enforcement Database Daily and weekly news alerts Intraday news alerts Dates for your diary UK, EU and international regulators and bodies Treasury Select Committee publishes letter from FCA CEO following recent evidence session The House of Commons (HoC) Treasury Select Committee (TSC) has issued a letter dated 30 April 2025 from Nikhil...

Waste from extractive operations (‘mining waste’) Mining waste encompasses materials that must be removed to gain access to mineral resources (but are not actually processed), for example topsoil, overburden and waste rock, as well as tailings—the material left over after the process of extracting the valuable content from an ore. Some fractions are inert and unlikely to present a significant environmental threat; others, in particular those from the non‑ferrous metal mining industry, may contain hazardous substances, such as heavy metals. For more information see Practice Note: Waste types and controls—extractive waste/mining waste The regulation of mining waste in England and Wales is primarily through the Environmental Permitting (England and Wales) Regulations 2016 (EPR 2016), SI 2016/1154 (as variously amended), which is the main regulatory legislation governing the environmental permitting and compliance regime applying to a range of activities and industries. EPR 2016 came into force on 1 January 2017 and consolidated all of the amendments to the Environmental Permitting (England and Wales) Regulations 2010 (EPR 2010), SI 2010/675. EPR...

Introduction What is groundwater? In brief, groundwater is water stored beneath the surface. Rainfall gathers and then infiltrates the soil, percolating through soils and rocks into aquifers—layers of porous rock or sediment. The British Geological Survey notes that groundwater supplies around one third of the public water in England and makes an important contribution in Wales and Scotland. What is groundwater activity Government guidance explains that a groundwater activity includes: discharging a pollutant that causes, or could cause, a direct or indirect input to groundwater any other discharge that may lead to a direct or indirect pollutant input to groundwater an activity subject to a Schedule 22 notice that has taken effect an activity, carried out as part of another class of regulated facility, that may cause such a discharge The guidance further states it is an offence to cause or knowingly permit a groundwater activity unless authorised by a permit or registered as exempt. Environmental...

Introduction Environmental permitting is among the principal environmental regulatory frameworks in the UK. Its purpose is to oversee and limit pollution and emissions into the environment arising from industrial and other operations across the UK. It forms a central strand of UK business regulation, created to manage and oversee activities that could pollute the environment or pose risks to human health. Permits place a suite of conditions on the design and build, running and, in due course, closure of a regulated installation, as well as stipulating how regulated activities are undertaken. The main regulators are the Environment Agency (EA) in England, Natural Resources Body for Wales (NRW), the Scottish Environment Protection Agency (SEPA) and the Northern Ireland Environment Agency (NIEA). Local authorities likewise regulate the less polluting processes and sites. The lead government departments/bodies (the appropriate authorities) are the Department for Environment, Food and Rural Affairs (Defra) for England together with the Secretary of State for Environment, Food and Rural Affairs (the Secretary of State); Welsh Ministers; Scottish Ministers;...