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 its annual clinical trials report showing patient recruitment into UK...
The European Commission announced that the Joint Research Centre (JRC) has launched BimmoH, a database housing scientific articles on human...
The National Institute for Health and Care Excellence (NICE) has announced that the government has confirmed it will increase the thresholds NICE uses...
The Science, Innovation and Technology Committee has launched an inquiry into the potential harms associated with hair and beauty products and...
The EU Member State Coordination Group on Health Technology Assessment (HTACG) has adopted its annual Health Technology Assessment Work Programme,...
Latest Life Sciences Practice Notes
Exclusion and limitation of liabilityThis Practice Note considers exclusion and limitation of liability in business-to-business (B2B) contracts. It...
Hague Convention on Choice of Court Agreements—scopeThis Practice Note considers the Hague Convention on Choice of Court Agreements which applies to...
Hague Convention on Choice of Court Agreements—application by contracting statesThis Practice Note considers the application of the Hague Convention...
Hague Convention on Choice of Court Agreements (jurisdiction and enforcement)—Brexit considerationsThis Practice Note considers how the Hague...
WTO—an introductory guideWhat is the World Trade Organization (WTO)?The WTO administers the WTO trade agreements which govern trade between states. It...
Latest Life Sciences Precedents
Board minutes approving a proposed commercial agreementCOMPANY NUMBER:[ insert company number][insert company name] [LIMITED OR PLC]Minutes of a...
Confidentiality agreement—one-way—pro-discloserThis Agreement is made on [date]Parties1[Insert name of party][ of [insert details] OR a company...
Confidentiality letter—mutual[insert address of sender]Our ref: [insert reference]Your ref: [insert reference][Insert address of recipient]Date:...
Confidentiality agreement—mutualThis Agreement is made on [date]Parties1[insert name of party] [of [insert details ] OR a company incorporated in...
Confidentiality letter—one-way—pro-discloser[insert address of sender]Our ref: [insert reference]Your ref: [insert reference][insert address 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.
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.
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.
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