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PRACTICE NOTES
The development of medicine, biomicrobiology and biotechnology has led to the emergence of a cutting-edge category of medicinal products that use gene therapy, somatic cell therapy and engineered tissues for preventing, treating or even curing human diseases. The novelty, complexity and diversity of such products has demanded new regulatory tools, both in terms of legislation and regulatory guidance, to allow an appropriate balancing of the risks and the benefits for the patients. EU and UK legislature regulates this category of products as ‘advanced therapy medicinal products (ATMPs)’ in order to ensure the highest level of protection of public health and to take into account their specific challenges, in particular with regard to clinical trials, manufacturing and pharmacovigilance. However, the regulation of genetically modified organisms (GMOs) which are used as starting materials for ATMPs remains national and therefore differs from one Member State to another. Such differences have led to a complex regulatory landscape for ATMPs. The regulation of tissues and cells is also currently
PRACTICE NOTES
This Practice Note is an introduction to the price control framework in the regulation of Great Britain (GB)’s electricity and gas networks. It explains what is meant by 'price control’ and why is it used for GB electricity and gas networks, how price controls are set and regulated by Ofgem through a licensing regime, and how charges are recovered from consumers. Finally, the Practice Note provides an overview of the main price control frameworks that have applied to GB electricity and gas networks, namely RIIO, RIIO-2 and RIIO-3. What is meant by 'price control’ and why is it used for electricity and gas networks in GB? ‘Price control’ refers to a model through which the charges levied by the owners of essential and/or monopoly assets are regulated. It was developed in the context of private ownership of public utilities, including electricity, gas and water networks, following their privatisation in GB in the late 1980s and early 1990s. Due to the nature of these assets, a post-privatisation
PRACTICE NOTES
This Practice Note provides guidance on the regulation of construction products by Regulation (EU) No 305/2011, the EU Construction Products Regulation. It also sets out relevant practical considerations, including tips for designers, employers, contractors and sub-contractors/suppliers. STOP PRESS: This Practice Note will be replaced by a new one, to reflect the adoption and publication in the Official Journal of Regulation (EU) 2024/3110, the Revised EU Construction Products Regulation. The Regulation entered into force on 1 January 2024 and applies on 8 January 2026. It repeals most of the provisions of the EU Construction Products Regulation from 8 January 2026. For more information, see: LNB News 18/12/2024 68. Overview of the regulatory regime EU Construction Products Regulation The EU Construction Products Regulation is a piece of EU law binding on all EU Member States, and other countries forming part of the European Economic Area (EEA). It came into force on 1 July 2013 and is self-executing in EU Member States (and therefore applicable in domestic law without any further national legislation).
PRACTICE NOTES
Why are construction products regulated? Construction products are regulated to: • ensure that a product being placed on the market complies with all legislative requirements, and • promote confidence in consumers, public authorities, and manufacturers regarding the conformity of products What sort of products are affected? Construction products are defined as ‘any product or kit which is produced and placed on the market for incorporation in a permanent manner in construction works or parts thereof and the performance of which has an effect on the performance of the construction works with respect to the basic requirements for construction works’. Construction products therefore include products such as doors, windows, shutters and gates, membranes, thermal insulation products, chimneys and flues, sanitary appliances, fire alarms, flooring, fire retardant products, space heating appliances, power cables, glass, fixings and many more. Key definitions Placing on the market ‘Placing on the market’ means the first making available of a construction product on the GB market’ as defined by UK government guidance. Making
PRACTICE NOTES
This Practice Note considers the regulation of consumer credit advertisements under the Financial Conduct Authority’s (FCA) Consumer Credit sourcebook (CONC 3). It covers how CONC 3 relates to the financial promotion restriction in section 21 of the Financial Services and Markets Act 2000 (FSMA 2000), summarises the general ‘clear, fair and not misleading’ requirements in CONC 3, outlines the FCA’s enforcement powers in the event of a breach of the rules, and considers the FCA’s review of CONC 3. Reviewing the financial promotion rules for consumer credit In its March 2026 report, Regulatory priorities: Consumer finance, the FCA said it planned to consult on CONC 3 to remove unnecessary prescription, update requirements and improve alignment with the Consumer Duty. Accordingly, Consultation Paper CP26/15, CONC 3—reviewing the financial promotions rules for consumer credit, was published on 29 April 2026. The FCA is not reviewing all of CONC 3. It expressly excludes CONC 3.4 on high-cost short-term credit (HCSTC) risk warnings, CONC 3.7 on credit brokers, CONC 3.7A on Peer-to-peer (P2P) agreements, and CONC 3.9 on debt counsellors
PRACTICE NOTES
What is an equity derivative? An equity derivative is a financial instrument that references and offers economic exposure to the performance of an equity asset or other equity-related variable from which the instrument's price or value is derived. Equity derivatives may be traded on an exchange or over the counter (see further details below). They may also be funded or unfunded. Equity derivatives are used primarily by funds and investors as speculative investments and by end users and banks as commercial hedges. However, they also have a variety of other uses which will be covered in further detail below. Types of equity derivative instruments Equity derivative instruments fall into the following five principal categories: • Options—the two main types of options are put options and call options. A put option holder has the right to sell an underlying asset (for example shares) to a counterparty for an agreed price on an agreed future date. A call option holder has the right to buy an underlying asset (for example shares) from a counterparty for
PRACTICE NOTES
This Practice Note examines some of the key aspects of regulation applicable to high-cost short-term credit (HCSTC) including its definitions, the regulatory framework, the Financial Conduct Authority’s (FCA) high-cost credit review and conduct requirements specific to providers of HCSTC (including limits on roll-overs, continuous payment authorities (CPAs), the use of price comparison websites (PCWs) and cost caps). From 15 July 2026 (Regulation Day), a significant part of the previously unregulated ‘Buy now, pay later’ (BNPL) market, specifically interest-free, short-term, third-party lender arrangements, will be brought within FCA regulation as deferred payment credit (DPC). This Practice Note focuses on the HCSTC regime. For more information about BNPL and the DPC regime (including the new perimeter and conduct requirements), see Practice Note: Buy now, pay later (BNPL) and deferred payment credit (DPC). What is 'high-cost short-term credit' High-cost credit, often referred to generically as payday lending, can include payday loans, home-collected credit, catalogue credit, rent-to-own (RTO), pawn-broking, guarantor and logbook loans. HCSTC is a specific category of regulated credit within this wider high-cost credit market.
PRACTICE NOTES
A range of statutory obligations regulate the acquisition, retention, examination and dissemination of private material by public authorities for intelligence purposes. These include: • Investigatory Powers Act 2016 (IPA 2016) • Regulation of Investigatory Powers Act 2000 (RIPA 2000) • Human Rights Act 1998 (HRA 1998) • Intelligence Services Act 1994 (ISA 1994) • Security Service Act 1989 (SSA 1989) • Computer Misuse Act 1990 (CMA 1990) • Wireless Telegraphy Act 2006 (WTA 2006) • Investigatory Powers (Interception by Businesses etc for Monitoring and Record-keeping Purposes) Regulations 2018, SI 2018/356 The IPA 2016 is supplemented by statutory codes of practice: • Interception of communications: code of practice • Equipment interference: code of practice • Communications data: code of practice • Bulk acquisition of communications data: code of practice • Bulk personal datasets—low or no reasonable expectation of privacy: code of practice • Notices regime: code of practice • Retention and use of bulk personal datasets: code of practice • Third party bulk personal datasets: code of practice Certain public authorities
PRACTICE NOTES
STOP PRESS: Please note that on 30 and 31 March 2026 the MHRA released an extensive series of guidance relating to the clinical investigations of medical devices which may impact the content of this Practice Note. Also, on 8 May 2026, the DHSC and MHRA published the draft Medical Devices (Amendment) Regulations 2026 for comment on the World Trade Organisation (WTO) notification portal and launched a stakeholder impact survey which when adopted as anticipated in December 2026 for an estimated entry into force in June 2027 will impact the content of this Practice Note significantly. The Future regulation of medical devices in the UK section of this Practice Note has been updated accordingly. However, we await for the details on its finalisation and transition. In the meantime, to follow these developments, please refer to the UK medical devices regulatory horizon scanner and tracker. This Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the key steps for placing a medical device on the market in Great
PRACTICE NOTES
This Practice Note provides an overview of the motor finance sector, including the work that the Financial Conduct Authority (FCA) has undertaken to review firms’ historical use of discretionary commission arrangements (DCAs) between lenders and credit brokers. It covers: • background on the work of the FCA in this sector • an introduction to motor finance, including types of motor finance • the regulated activities relevant to motor finance • the key regulatory requirements that are relevant to motor finance, covering the FCA Handbook and the Consumer Credit Act 1974 (CCA 1974) • an overview of the process for making complaints against firms in the motor finance sector and also when referring a case to the Financial Ombudsman Service (FOS) • analysis of high profile cases in the motor finance sector including the landmark Supreme Court judgment in Johnson v FirstRand Bank Ltd (London Branch) (trading as MotoNovo Finance) and other cases • the FCA’s Policy Statement PS26/3: Motor Finance Consumer Redress Scheme (CRS), which establishes an industry-wide scheme to provide redress in relation to motor finance
PRACTICE NOTES
Role of the Pensions Regulator Statutory objectives The core role of the Pensions Regulator is to fulfil the statutory objectives set out in the Pensions Act 2004, s 5 (PeA 2004). These are: • to protect the benefits of, or in respect of, members of occupational pension schemes • to protect the benefits of, or in respect of, members of personal pension schemes who are: ◦ employees in respect of whom there are 'direct payment arrangements' (defined below), and ◦ where the scheme is a stakeholder pension scheme, any other members • to reduce the risk of situations arising which may lead to compensation being payable from the Pension Protection Fund • in respect of defined benefit scheme funding, to minimise any adverse impact on the sustainable growth of an employer • to maximise compliance with auto-enrolment duties (for further information on which, see Practice Note: Auto-enrolment—an introduction) • to promote and to improve understanding of the good administration of 'work-based pension schemes', ie: ◦ an occupational pension scheme
PRACTICE NOTES
This Practice Note visually highlights the enforcement bodies which have responsibility for enforcing UN and UK sanctions under the Sanctions and Anti-Money Laundering Act 2018 (SAMLA 2018) in the UK. The following bodies and abbreviations are referenced: • Foreign, Commonwealth & Development Office (FCDO)