About Life Sciences Law
Lexis®+ Life Sciences is an online practical guidance product for contentious and non-contentious lawyers providing advice to and supporting the UK’s Life Sciences sector.
Research and development
Highly regulated, with strict compliance rules, work can be in-house or in collaboration with another entity. Guidance includes practice notes on UK and EU regime for clinical trials and various precedents.
Intellectual property
Patents and supplementary protection certificates are significant to many life sciences businesses. We have practice notes on pharmaceutical patents, biotechnology patents, IP protection for medical devices and more.
Medicinal products
This content includes guidance on marketing authorisations, orphan and paediatric medicines, pharmacovigilance, manufacturing, unlicensed and off-label medicines.
Medical devices
Covering key areas of medical devices regulation including classification, conformity assessments, clinical and performance evaluation as well as post-market surveillance.
Topics We Cover
Latest Life Sciences News
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened applications for an expanded AI Airlock programme following last year's...
The European Association of Medical devices Notified Bodies (Team NB's) IVD Software Working Task Force, representing 15 notified bodies, has...
The Medicines and Healthcare products Regulatory Agency (MHRA) has published draft guidance to support implementation of the Medicines for Human Use...
The European Commission has adopted Regulation (EU) 2025/1234, new rules allowing all medical devices used by professionals to include electronic...
This week's edition of Life Sciences weekly highlights includes news that the Artificial Intelligence Board and MDCG published a joint guidance...
Latest Life Sciences Practice Notes
The Windsor Framework—trade between Northern Ireland, the UK and EUIntroductionOn 27 February 2023 UK Prime Minster Rishi Sunak and EU Commission...
WTO—an introductory guideWhat is the World Trade Organization (WTO)?The WTO administers the WTO trade agreements which govern trade between states. It...
Brexit legislation tracker 2017–19 [Archived]ARCHIVED: This Practice Note has been archived and is not maintained. It tracks the progress of UK...
Assimilated lawIntroductionThe body of domestic law derived originally from EU obligations and established by the European Union (Withdrawal) Act 2018...
Brexit—introduction to the Withdrawal AgreementThe UK’s formal withdrawal from the EU took effect at 11 pm on 31 January 2020 (exit day). At this...
Latest Life Sciences Precedents
Retained EU law—training materials [Archived]ARCHIVED: This Precedent has been archived and is not maintained.These training materials consist of...
Sustainability glossary terms (The Chancery Lane Project)These Precedent sustainability definitions, produced by The Chancery Lane Project (TCLP) as...
Hardship clauseHardship•means[, subject to clause [1.6 OR 1.7],] a [fundamental OR material] change in the balance of a party’s benefits and...
Data protection schedule—Life SciencesParties1[Insert the company name (the name of the sponsor)] with a registered office at [insert address]...
Consultancy agreement—company and individual—pro-clientThis Agreement is made on [insert date]Parties1[Name of Company], a company incorporated in...
Latest Life Sciences Q&As
Featured Life Sciences content
Introduction to technology transfer agreements in the Life Sciences industry
Introduction to technology transfer agreements in the Life Sciences industryWhat is a technology transfer agreement?The term ‘technology transfer...
Regulation of cosmetic products in the UK
Regulation of cosmetic products in the UKThis Practice Note provides an overview of the UK regulatory framework for cosmetics. It sets out the legal...
Intellectual property protection for medical devices
Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...
Second and subsequent medical use patent claims
Second and subsequent medical use patent claimsBackground to medical use claimsSecond (and subsequent) medical use patent claims are specific to the...
The experimental use and Bolar-type exemptions to patent infringement
The experimental use and Bolar-type exemptions to patent infringementPatent systems are intended to foster innovation, not to impede it. For this...
The 2024 ABPI Code of Practice—what are the key proposed changes?
The PMCPA has recently launched a consultation to update:•the 2021 ABPI Code of Practice•the Constitution and Procedure which sets out how the PMCPA...
Clinical Research Organisation (CRO) master services agreement
Clinical Research Organisation (CRO) master services agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
The EU Clinical Trials Regulation
The EU Clinical Trials RegulationThis Practice Note looks at Regulation (EU) 536/2014, the EU Clinical Trials Regulation (CTR), which governs clinical...
Medical devices due diligence questionnaire
Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
Biotechnology patents
Biotechnology patentsPatenting biotechnological inventionsBiotechnological inventions are, in principle, patentable. While there is no general...
Unlicensed medicinal products and off-label use of medicinal products
Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
MHRA releases guidance on pharmacovigilance following Windsor Framework agreement
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the implementation of changes to pharmacovigilance for...
The regulation of medical devices in the UK
The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
Court of Appeal allows appeal in British Standards v RRR Manufacturing
The National Archives has published the judgment in British Standards Institution v RRR Manufacturing Pty Ltd, R (on the application of) [2024] EWCA...
CMA announces Phase 1 merger inquiry into Roche Diagnostics
The Competition and Markets Authority (CMA) has announced a Phase 1 merger inquiry into Roche Diagnostics Ltd's acquisition of point-of-care testing...
DSIT publishes international scientific report on advanced AI safety
The Department for Science, Innovation and Technology (DSIT) has released the interim International Scientific Report on the Safety of Advanced...
The regulation of advanced therapy medicinal products
The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
Associated legal terms
Marketing Authorisation
The approval needed to place a medicinal product on the market. It sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the holder of the marketing authorisation.
Medicinal Product
Any substance or combination - presented as having properties for treating or preventing disease in humans; or - which may be administered to humans either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
Originator
Another term for reference medicinal product, which has been granted a authorisation'>marketing authorisation (MA) on the basis of a complete dossier in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, and to which the application for MA for a generic medicinal product refers, by demonstration of bioequivalence.
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