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 Department of Health and Social Care (DHSC) has launched a consultation on proposals to restrict high-risk cosmetic and wellbeing procedures in...
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the government will continue to accept CE marked medical devices and...
The European Association of Medical Devices Notified Bodies (Team-NB) has published version 5.3 of its Code of Conduct, adding a new section on...
The European Medicines Agency (EMA) has launched a consultation on a draft framework to improve adverse drug reaction reports for human and veterinary...
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that its Deputy Director for Artificial Intelligence (AI) and Software,...
Latest Life Sciences Practice Notes
This Practice Note provides an introduction to design law and covers the various design rights (both registered and unregistered) that can be relied...
This Practice Note considers selected common law issues that arise in relation to jurisdiction agreements under English law. It focuses on matters of...
What is meant by ‘personalised medicines’?The term ‘personalised medicine’, or sometimes ‘targeted medicine’, is generally used to describe treatments...
This Practice Note is intended to be used to track the progress of UK legislative proposals, consultations and other key regulatory and governance...
This Practice Note provides an introduction to supplementary protection certificates (SPCs) and paediatric extensions (PEs) in the UK. It explains the...
Latest Life Sciences Precedents
This Agreement is made on [insert date] (the Commencement Date) between the following parties (each a ‘party’ and together the...
CLAIM No: [insert claim number]IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY Division[INSERT COURT/LIST/SUB-LIST]BETWEEN[insert full name of...
CLAIM No: [insert claim number]IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY Division[INSERT COURT/LIST/SUB-LIST]Between:[insert full name of...
This Agreement is made on [insert date]parties1[insert name of manufacturer ][of OR a company incorporated in [England and Wales] under number [insert...
Parties1[Insert the company name (the name of the sponsor)] with a registered office at [insert address] hereinafter referred to as the Controller;...
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
Medical device
Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for a medical purpose, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on 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.
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
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