Pharmacovigilance meaning

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 Free movement, immigration and employment Financial services Energy Environment Life sciences TMT International trade Daily and weekly news alerts New and updated content Trackers Free movement, immigration and employment The European Parliament’s Employment and Social Affairs Committee has endorsed a report proposing amendments to the draft EU Traineeship Directive. Backed by 42 votes to nine, it provides a clear definition of a traineeship, mandates written agreements, limits placements to six months, and secures social protection for trainees. The measures are designed to deter employers from using traineeships to conceal standard employment relationships. The Committee also voted to launch interinstitutional negotiations, with discussions with the Council slated to begin after the next plenary, assuming no objections arise. See: LNB News 23/09/2025 21. Financial services The European Banking Authority (EBA) has released its advice and recommendations in answer to the European Commission’s call for advice on the assessment and review of...

In this issue: Intellectual property Post-market Competition in life sciences Commercialisation Data protection and life sciences Advanced therapeutics Pharmaceuticals—regulatory framework Research and development Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Patenting AI innovations in healthcare—navigating European patent law Jack Severs (partner) and Joe Spencer (associate) of Gill Jennings & Every LLP explore what is considered patent-eligible in European AI healthcare. See News Analysis: Patenting AI innovations in healthcare—navigating European patent law. Dapagliflozin—UK court reaffirms plausibility standard despite G 2/21 In Generics (UK) Ltd v AstraZeneca AB, the High Court of England and Wales delivered a thorough restatement of the UK tests for inventive step and sufficiency, anchored in the idea of ‘plausibility’. Ian Jones, partner at Gill Jennings & Every LLP, assesses the ruling. The judgment in Generics (UK) Ltd v AstraZeneca AB [2025] EWHC 1012 (Pat) underscores the UK’s growing departure...

This Practice Note examines unlicensed medicines and the routes by which they can reach patients across the EU and the UK, such as via the UK Specials regime. It then looks at deploying authorised medicines beyond the scope of their licence (commonly termed off-label use). Lastly, the Practice Note addresses liability questions linked to using medicines without a licence. The UK’s regime governing unlicensed products is largely rooted in EU legislation. Numerous EU-derived principles and obligations remain in UK domestic law, save where particular measures provide otherwise. The Note surveys both EU and UK frameworks: analysis of EU requirements should be treated as relevant to the UK system unless distinct UK rules departing from EU law are set out separately. It also summarises pertinent EU case law; for guidance on the extent to which UK courts and tribunals are bound after the Brexit implementation period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit? The discussion covers availability routes,...

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...