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
MLex: Manufacturers of medical devices would see compliance with the EU AI Act's high-risk regime eased under a European Commission proposal. Part of...
This week's edition of Life Sciences weekly highlights includes news that the Council of the EU and the European Parliament have reached a provisional...
Banking & Finance analysis: The case of Macdonald Hotels alarmed lenders and their lawyers earlier in the year, with obiter comments suggesting that,...
The European Commission has published the draft European Biotech Act and a related draft directive on genetically modified micro-organisms, setting...
The European Commission has published a proposal to amend the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation...
Latest Life Sciences Practice Notes
Pre-Action Protocol on Media and Communications ClaimsThis Practice Note provides guidance upon the application of the Pre-Action Protocol on Media...
How to review an NDA for commercial transactionsThis Practice Note is a ‘how to’ guide on reviewing an NDA (also known as a non-disclosure agreement...
Parallel imports—UKThe legal frameworkThis Practice Note explains trade mark law on parallel trade. Parallel imports, or ‘grey market’ goods, are...
Patents tracker—UKThis Practice Note tracks the progress of judgments, legislative proposals and current consultations, guidance and reports related...
Agriculture/Food—EU Regulatory trackerThis Practice Note tracks and summarises EU regulatory legislation guidance and other ongoing policy...
Latest Life Sciences Precedents
Confidentiality letter—one-way—pro-discloser[insert address of sender]Our ref: [insert reference]Your ref: [insert reference][insert address of...
Confidentiality agreement—one-way—pro-recipientThis Agreement is made on [date].Parties1[Insert name of party] [of [insert address] OR a company...
Confidentiality agreement—short formThis Agreement is made on [date]Parties1[insert name of party] [of [insert details ] OR a company incorporated in...
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-recipient[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
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.
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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