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 Association of the British Pharmaceutical Industry (ABPI) has published a report calling for improved early warning systems to reduce medicines...
This week’s edition of Life Sciences weekly highlights includes news that the Health Research Authority (HRA) implemented updated operational guidance...
MedTech Europe has published a statement on Commission Implementing Regulation (EU) 2026/977, which introduces harmonised procedural requirements for...
MedTech Europe has published a paper outlining its position on the European Commission's proposal to reform the regulatory framework for medical...
The Council of Europe Committee of Ministers has adopted Recommendation CM/Rec(2026)7 setting out best practices for the remote and online provision...
Latest Life Sciences Practice Notes
This Practice Note explains what know-how is and sets out the different ways know-how can be protected before providing guidance on issues relating to...
This Practice Note provides a summary of the key aspects of the Data (Use and Access) Act 2025 (DUAA 2025) from an information law perspective. DUAA...
This Practice Note tracks key developments relating to the Data (Use and Access) Act 2025 (DUAA 2025) which received Royal Assent on 19 June 2025 and...
STOP PRESS: The Tobacco and Vapes Act 2026 received Royal Assent on 29 April 2026 and came partially into force on that date. The Tobacco and Vapes...
This Practice Note is intended to be used to track the progress of UK cases relevant to the life sciences sector.Jump...
Latest Life Sciences Precedents
Strictly private and confidentialTo: [insert buyer name][insert buyer address]Date: [insert date]Dear [insert buyer contact name],Proposed acquisition...
This Agreement is made on [insert date]Parties1[Name of Company], a company incorporated in England and Wales with registered number [insert company...
This Agreement is made on [date]Parties1[Name of Company], a company incorporated in England with registered number [insert company number] whose...
[insert address of trade mark proprietor]Our ref: [insert reference]Your ref: [insert reference][insert address of recipient][insert date]Dear [insert...
This Agreement is made on [insert date]parties1[insert name of customer ][of OR a company incorporated in [England and Wales] under number [insert...
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
CE mark
Mandatory conformity marking for certain products sold within the EEA, including medical devices. It shows that the manufacturer has checked that these products meet EU safety, health or environmental requirements, is an indicator of a product’s compliance with EU legislation and allows the free movement of products within the EEA.
Generic
A medicinal product which contains the same active substances and has the same pharmaceutical form as the original branded reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies, as defined in Article 10(2)(b) of Directive 2001/83/EC.
Specials
Unlicensed medicinal products for human use which have been specially manufactured or imported to the order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for the treatment of individual patients in order to fulfil the special needs of an individual patient.
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