Transparency Directive meaning

Checklist This Checklist sets out the practical actions for creating, drafting and quality-checking a Participant Information Sheet (PIS) for UK clinical research. It describes what the PIS is for and how it works, and gives hands-on advice on the essential components, addressing content and presentation alongside layout, format and style. The Checklist also explains how the PIS should meet obligations under UK data protection law, including the transparency duties in the United Kingdom General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR). It is suitable for any study involving human participants, with particular emphasis on clinical trials of investigational medicinal products (CTIMPs). A clinical trial is a study in human subjects intended to identify or confirm the effects of an adverse reaction to a medicinal product. In the UK, such trials are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (MHU(CT)R 2004), SI 2004/1031, which transposed EU Directive 2001/20/EC, the Clinical Trial Directive (CTD), into domestic law. These rules create a legal framework designed to...

In this issue: Economic Crime and Corporate Transparency Act 2023 Equity capital markets Private M&A (share purchase) Corporate governance—EU Members Company restoration Daily and weekly news alerts Dates for your diary Trackers Useful information New Q&As Economic Crime and Corporate Transparency Act 2023 Companies and Limited Liability Partnerships (Protection and Disclosure of Information and Consequential Amendments) Regulations 2024 SI 2024/1377: These Regulations update LLP company law to reflect recent changes under the Economic Crime and Corporate Transparency Act 2023 and expand the scenarios in which a person’s residential address can be withheld from the company register, covering former registered office addresses, while maintaining corporate openness and aligning LLP provisions. They commence on 27 January 2025. See: LNB News 07/11/2024 27. Equity capital markets The Financial Conduct Authority has released Policy Statement PS24/19: Enhancing the National Storage Mechanism, setting out the feedback to Consultation Paper CP24/17, its longer-term vision for the NSM, and...

In this issue: Advertising, marketing and sponsorship Agency and distribution Consumer protection Contracts E-commerce International Public procurement Supplier management LexTalk®Commercial: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Advertising, marketing and sponsorship ASA rulings—31 July 2024 The Advertising Standards Authority (ASA) has flagged the Person(s) unknown trading as Mendio Life for inquiry after insights from its Active Ad Monitoring system. A Meta promotion by Mendio Life for an acupressure clip asserted medical effects for a device lacking the necessary conformity marking and absent from the Medicines and Healthcare Products Regulatory Agency (MHRA) register. This decision sits within the ASA’s wider work on advertisements asserting treatment for prostrate issues, as part of a consumer-protection drive against such claims. The ASA also received a complaint about Nultqh GB’s Meta advert for a prostate patch, which advanced medicinal claims for an unlicensed item. The...

In this issue: UK, EU and international regulators and bodies Authorisation, approval and supervision Prudential requirements Financial crime and sanctions Consumer protection Complaints, compensation and claims management Investigations, enforcement and discipline Regulation of capital markets Dispute resolution for financial services lawyers Regulation of derivatives Sustainable finance and ESG Banks and mutuals UK MiFID II EU MiFID II Consumer credit Regulation of insurance Payment services and systems Fintech and cryptoassets LexTalk®Financial Services: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary UK, EU and international regulators and bodies FCA publishes Handbook Notice No 135 The Financial Conduct Authority (FCA) has issued Handbook Notice No 134, outlining amendments to the FCA Handbook and related materials approved by the FCA board on 27 November 2025. See: LNB News 28/11/2025 48. ESMA sets out planned consultations for...

Resource Note This Resource Note signposts key commentary, analysis and materials to aid interpretation and offer practical direction on using Chapter 2 of the Disclosure Guidance and Transparency Rules (DTR 2). Where relevant, it draws on: the Financial Conduct Authority (FCA) Handbook FCA Knowledge Base—Procedural and Technical notes (formal guidance binding on the FCA) FCA consultation and discussion papers, policy and feedback statements, and warnings Primary Market Bulletins and other FCA publications legacy UKLA technical and procedural notes and the UKLA’s newsletter List!, where still pertinent assimilated EU legislation EU Directives and EU Regulations, where helpful to construing a provision Lexis+® UK analysis and resources Setting the scene What it covers: DTR 2 prescribes the framework for issuers to disclose and manage inside information, supporting timely and even-handed release of market-sensitive information. It also identifies specific situations permitting a delay to public disclosure of inside information, together with the safeguards required to keep such information...

This Resource Note spotlights commentary, analysis and materials to aid interpretation and give practical guidance on applying Chapters 1, 1A, 1B and 1C of the Disclosure Guidance and Transparency Rules: DTR 1, DTR 1A, DTR 1B and DTR 1C respectively. Materials referenced here include, where pertinent: the Financial Conduct Authority (FCA) Handbook FCA Knowledge Base guidance—Procedural notes and Technical notes (constituting formal guidance and binding on the FCA) FCA consultation papers, discussion papers, policy statements, feedback statements and warnings Primary Market Bulletins and other FCA publications former UKLA technical and procedural notes and the UKLA newsletter List!, where still relevant to interpreting or applying a provision assimilated EU legislation EU Directives and EU Regulations, where relevant to interpreting a provision Lexis+ UK analysis and resources Setting the scene What it covers: DTR 1 sets out the Disclosure guidance, explaining its scope and purpose; DTR 1A sets out the transparency rules with their scope and purpose;...

Nanotechnology—opportunities and risks Nanotechnology deals with the fabrication and application of matter at ultra-small scales. Nanomaterials are quantified in nanometres (nm) and can be many thousands of times thinner than a human hair; a single hair measures around 80,000 to 100,000 nm across. At these dimensions, substances display properties that diverge from those of the same material in bulk form, enabling novel uses while potentially introducing distinct hazards. Current adopters span key fields and wider industries: Biomedicine, electronics and energy Cosmetics, defence, automotive and agriculture Applications range from high-volume commodities, for example carbon black in car tyres, through to specialised, low-volume technologies. Cosmetics commonly incorporate nano titanium dioxide and zinc oxide to deliver functions such as UV filtering, while gold and silver nanoparticles feature in medical diagnostic tools. A 2023 report put the global nanotechnology market at US$69.15bn in 2022, projecting expansion to US$248.56bn by 2030. The European Commission regards micro/nano—electronics and photonics as a Key Enabling Technology that should be...

STOP PRESS: On 19 June 2025, the Data (Use and Access) Bill secured Royal Assent, transforming into the Data (Use and Access) Act 2025 (DUAA 2025), with partial commencement on that very same day. A number of DUAA 2025 provisions, covering areas like handling data subject access requests and granting powers to make additional regulations, took effect immediately on 19 June 2025. Other related provisions, relating to Information Commissioner notices and certain aspects of law enforcement processing, commenced on 19 August 2025 (being two months from the date of Royal Assent). The majority of DUAA 2025’s measures still require further regulations, in the form of statutory instruments, to be made in order to bring them fully into force. Parts 5 and 6 of DUAA 2025 serve to amend several facets of data protection and ePrivacy law in the UK, including the United Kingdom General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR), the Data Protection Act 2018, and the Privacy and Electronic Communications (EC Directive) Regulations 2003, SI...

STOP PRESS: On 19 June 2025, the Data (Use and Access) Bill secured Royal Assent, becoming the Data (Use and Access) Act 2025 (DUAA 2025), with partial commencement on that date. In force from 19 June 2025: provisions on handling data subject access requests and the granting of powers to make further regulations. In force from 19 August 2025 (two months after Royal Assent): measures relating to notices from the Information Commissioner and certain aspects of law enforcement processing. The majority of DUAA 2025’s measures will commence only when further regulations, in the form of statutory instruments, are made. Parts 5 and 6 of DUAA 2025 amend elements of UK data protection and ePrivacy law, including the United Kingdom General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR), the Data Protection Act 2018, and the Privacy and Electronic Communications (EC Directive) Regulations 2003, SI 2003/2426...