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
Life Sciences analysis: Hélène Boland, senior associate and Fabien Roy, partner of Hogan Lovells, consider the key takeaways from the MDCG 2025-6...
The Department of Health and Social Care (DHSC) has announced the development of AI system to monitor National Health Service (NHS) patient safety in...
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The Medicines and Healthcare products Regulatory Agency (MHRA) has published draft guidance to support implementation of the Medicines for Human Use...
Latest Life Sciences Practice Notes
The EU MDR and IVDR implementing acts and guidance trackerThis Practice Note tracks the progress of amending legislation, implementing acts, key...
Brexit timelineOn 23 June 2016, the UK held a referendum on its membership of the EU, with a majority voting in favour of the UK leaving the EU. On 29...
Brexit legislation trackerThis Practice Note tracks the progress of UK legislation introduced as part of the legislative project associated with the...
Digital health—data protection and privacy case studiesWith thanks to Alexander Wilhelm and Charlotte Guérin of Latham & WatkinsWhat is digital...
Trade secrets and confidential information—protection and enforcementThis Practice Note sets out the protection available for trade secrets and...
Latest Life Sciences Precedents
Consultancy agreement—company and company—pro-clientFORTHCOMING CHANGE: On 19 June 2025, the Data (Use and Access) Bill received Royal Assent,...
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]...
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
In-vitro diagnostic medical device
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in-vitro for the examination of specimens derived from the human body.
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.
Regulatory data protection
Refers to the data exclusivity period granted by Article 10(1) of Directive 2001/83/EC, in which pre-clinical and clinical trial data generated and used to support the authorisation of an innovative medicinal product cannot be referred to by an applicant for a marketing authorisation for a generic product.
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