Medicinal Product 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...

Medicinal products cannot be marketed without prior approval in place. This Flowchart sets out the steps and requirements to obtain approval, referred to as a marketing authorisation (MA), through the EU decentralised route. The decentralised pathway allows marketing authorisations for medicinal products to be granted concurrently across EU Member States in parallel and simultaneously...

Flowchart No medicinal product can be placed on the market unless regulatory approval has been granted in advance. The Flowchart explains the steps to secure an approval—termed a marketing authorisation (MA)—through the mutual recognition procedure (MRP)...

This diagram outlines the standard lifecycle of a medicinal product...

In this issue: Advertising, marketing and sponsorship Consumer protection E-commerce International Daily and weekly news alerts New and updated content Dates for your diary Trackers Advertising, marketing and sponsorship ASA rulings—14 August 2024 The Advertising Standards Authority (ASA) is continuing to address promotions claiming to treat menopausal symptoms. Drawing on a complaint and its own intelligence, the ASA examined specific TikTok ads to determine whether they asserted medicinal properties for an unlicensed product. The complaint was upheld. See: LNB News 14/08/2024 21. Consumer protection CMA secures final commitments from Worcester Bosch to change marketing practices The Competition and Markets Authority (CMA) has confirmed it obtained final commitments, in the form of undertakings, from Worcester Bosch to amend its marketing practices. This follows the CMA opening a formal investigation in October 2023 into whether Worcester Bosch breached consumer protection law by making potentially misleading claims to shoppers about its ‘hydrogen-blend ready’ home boilers...

In this issue: Post-market Intellectual property Pharmaceuticals—regulatory framework Research and development Medical devices Daily and weekly news alerts New and updated content Trackers Useful information Post-market What’s next for UK product liability? Andrew Austin, partner; Harriet Hanks, counsel; and Rachel Duffy, senior associate at Freshfields LLP, examine the UK Law Commission’s review of the domestic product liability framework for defective goods, with a particular lens on emerging technologies such as artificial intelligence, and set against notable recent developments in the EU. See News Analysis: What’s next for UK product liability? EMA updates pharmacovigilance requirements and ends EudraVigilance pilot phase The European Medicines Agency (EMA) has released guidance following adoption of Commission Implementing Regulation (EU) 2025/1466, which amends Regulation (EU) No 520/2012. This change formally concludes the EudraVigilance signal detection pilot for Marketing Authorisation Holders (MAHs), and requires all MAHs with authorised medicinal products in the EEA, including Northern Ireland, to monitor EudraVigilance...

In this issue: Medical devices Data protection and life sciences Research and development Commercialisation Advertising of medicines Disputes and regulatory enforcement Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices Government reaction to Whitehead Review on systemic bias in UK medical devices Harriet Hanks, counsel, Sanjana Canumalla, associate, and Matt Allison, trainee, at Freshfields Bruckhaus Deringer, examine and reflect on the findings of the Whitehead Review into equity in medical devices, published on 11 March 2024. See News Analysis: UK government responds to Whitehead Review’s findings of systemic bias in UK medical devices. Guidance on content of Investigator’s Brochure for clinical investigations of medical devices issued The Medical Device Coordination Group (MDCG) has published guidance on the Investigator’s Brochure (IB) for clinical investigations of medical devices (MDCG 2024-5). The document, grounded in Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), is...

(OMPs) are medicines that help prevent, identify or treat rare illnesses and medical conditions. Because the number of people affected is very small, without incentives, pharmaceutical companies may doubt whether sales would cover the research and development (R&D) costs of medical products to detect, prevent and treat such disorders. In the relevant EU law, 'rare' is defined as affecting fewer than five in 10,000 people in the EU. Yet most rare conditions impact fewer than one in 100,000 people. Although each individual rare disease is uncommon, they carry major public health importance and significance. There are thought to be more than 6,000 distinct rare diseases; so, while each is infrequent on its own, together they account for a substantial patient population, roughly one in every 12 people in the EU (all rare diseases combined). In the absence of incentives, it is frequently not commercially feasible for pharmaceutical companies to develop and market OMPs, and only about 5% of rare diseases currently have an authorised treatment option available...

A–B | C–D | E–H | I–N | O–P. Qualified person (QP) The qualified person (QP) must confirm that every batch of medicinal products is manufactured and checked in line with UK or EU Member State law and in keeping with the marketing authorisation (MA) terms. See also: batch release marketing authorisation (MA) medicinal product Practice Note: Manufacturing of medicinal products for human use Qualified person for pharmacovigilance (QPPV) A qualified person for pharmacovigilance (QPPV) is the individual who, by law, holds personal responsibility for the safety of a human medicinal product. See also: adverse reaction marketing authorisation (MA) medicinal product Practice Note: Pharmacovigilance Rare disease See: orphan medicinal product (OMP)...

This Practice Note sets out what are termed ‘biosimilars’, meaning comparable biological medicinal products. It outlines the commercial significance of biosimilars and highlights key challenges encountered by biosimilar manufacturers and biologic originator companies. It reviews the UK and EU regulatory regimes for these medicines and covers matters relating to biosimilar marketing authorisations (MAs), pharmacovigilance monitoring, and the manufacture and market access of biosimilars, eg pricing and reimbursement considerations. It also briefly addresses the position in the US and sets out the US Food and Drug Administration (FDA) procedures for biosimilars. In addition, it examines certain patent issues connected with biosimilars, including application of the Bolar-type exemption, considerations around the ‘clearing the way’ principle, and the Unified Patent Court (UPC), together with the scope for development of its jurisprudence concerning biosimilars. What is a biosimilar? A biosimilar is a biological medicinal product that is similar to a biological medicinal product—the originator, also referred to as the reference medicinal product—which has already been granted a MA on the basis of...

Introduction This due diligence questionnaire on medicinal products regulation concerns the intended purchase by [ insert buyer name ] (the Buyer) of the [ entire share capital of [ insert name of target company ] Limited, incorporated in England and Wales under number [ insert company number ] (the Company) OR [ insert description of the business to be acquired ] (the Business) as a going concern, together with specified assets used in the Business ] from [ insert seller name ] (the Seller) (the Proposed Acquisition). Its purpose is to equip the Buyer, the Buyer’s solicitors and other professional advisers with the legal information on UK and EU medicinal products regulatory compliance of the [ Company OR Business ], to support the Buyer’s valuation of the [ Company OR Business ] and to facilitate negotiation of the Proposed Acquisition. Please answer every question in full. Set out your responses in italics directly beneath each question and attach copies of all relevant documents. Ensure that each answer...

Every medicinal product in the EU undergoes rigorous, systematic testing and evaluation of its quality, effectiveness and safety before it is authorised for use. After it reaches the market, continuous surveillance ensures that any factor which might influence a medicine’s safety profile is identified and evaluated carefully, and that appropriate actions are taken when needed. This ongoing monitoring is known as pharmacovigilance in the EU...