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 European Commission’s Medical Device Coordination Group (MDCG) has published new guidance (MDCG 2025-10) clarifying post-market surveillance (PMS)...
The UK government has announced that an artificial intelligence forecasting tool has been rolled out across 50 NHS organisations in England to help...
Team-NB has published a position paper on the European Commission’s draft implementing regulation on Annex VII, welcoming efforts to improve the...
The European Commission has published MDCG 2025–10, a new guidance document on post-market surveillance of medical devices and in vitro diagnostic...
The Medicines and Healthcare (MHRA) products Regulatory Agency has launched an open call for evidence to inform the work of the National Commission...
Latest Life Sciences Practice Notes
The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operatorsThis Practice Note considers the...
The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified BodiesThis Practice...
Exclusion and limitation of liabilityThis Practice Note considers exclusion and limitation of liability in business-to-business (B2B) contracts. It...
DeedsUnder English law, legally binding agreements can be made orally, in writing or by deed.This Practice Notice considers the circumstances in which...
Electronic signaturesThis Practice Note describes the law of electronic signatures (also known as digital signatures, e-signatures, E-Signatures,...
Latest Life Sciences Precedents
Non-confidential disclosure letter agreement[insert address of sender]Our ref: [insert reference]Your ref: [insert reference][insert address of...
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...
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
Accelerated assessment
Many countries offer a regulatory pathway that will expedite the evaluation of certain medicinal products so that they reach patients faster. In the EU, the accelerated assessment procedure reduces the timeframe for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing authorisation (MA) application from 210 to 150 evaluation days. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation. In the UK, the Medicines and Healthcare Regulatory Agency (MHRA) offers a 150-day assessment timeline for all high-quality new MA applications in an effort to accelerate the availability of new medicines for patients in the UK. The MHRA evaluates the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland MA and reaches its opinion on whether to approve the licensing of new medicines within 150 days of submission of a valid application. See also: marketing authorisation (MA).
Clinical trial
An investigation conducted in human subjects which aims to discover or verify the effects of and adverse reactions to a medicinal product, ie, it assesses a medicine’s efficacy and safety.
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.
CONTACT US
