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 updated its guidance on clinical investigations for medical devices, with revisions...
The European Medicines Agency (EMA) has published the European Medicines Agencies Network Data Strategy on 3 October 2025, following a public...
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a blog welcoming the revision of the EU’s General...
The Competition and Markets Authority’s Subsidy Advice Unit (SAU) has published a report evaluating the proposed Life Sciences Large Investment...
This week's edition of Life Sciences weekly highlights includes news that MedTech Europe urged the European Commission to promptly address regulatory...
Latest Life Sciences Practice Notes
IP—new starter patents guideThis new starter guide provides an introduction to patent law. It focuses on highlighting the basic principles that apply...
Execution formalities—personal representativesThis Practice Note provides guidance on the execution of documents by personal representatives (PRs). It...
Agriculture/Food—EU Regulatory trackerThis Practice Note tracks and summarises EU regulatory legislation guidance and other ongoing policy...
Competition law in the pharmaceutical sectorThis Practice Note covers the application of EU and UK competition law to common practices that take place...
Boilerplate clauses in business-to-consumer contracts—specific clausesFORTHCOMING CHANGE: On 24 May 2024, the Digital Markets, Competition and...
Latest Life Sciences Precedents
Letter of claim—patent infringementLetter of claim—patent infringement[Alleged infringer’s name and address][Date]Dear [insert organisation...
Declaration of a director’s interests in a proposed transaction or arrangement—general noticeThe directors[Insert name of company] ([Company])[Insert...
Briefing for directors—general duties under the Companies Act 2006Every director of a company owes a number of duties to the company they are...
Declaration of a director’s interests in an existing transaction or arrangement—general noticeThe Directors[Insert name of company][(Company)][Insert...
Declaration of a director’s interests in a proposed transaction or arrangement—notice in writingThe directors[Insert name of...
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
Biosimilar
A medicinal product that is similar to a biological medicinal product (the originator or ‘reference’ product) that has already been granted a authorisation'>marketing authorisation in the EEA, but which does not meet the definition of a generic medicinal product owing, in particular, to differences in raw materials or manufacturing processes.
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.
Notified body
An organisation that has been appointed by the authorities'>competent authorities of a Member State to conduct conformity assessment procedures in respect of medical devices and verify the conformity of the manufacturer with the requirements of the medical devices legislation. The Notified Bodies are listed on the Commission website.
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