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
Our Top Sources
Latest Life Sciences News
The Health Research Authority (HRA) in collaboration with the Medicines and Healthcare products...
The European Medicines Agency (EMA) has updated guidance on good manufacturing and distribution...
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued recom...
An EU committee has found that 'many pharmaceuticals' fall under the definition of per- and pol...
The Advertising Standards Authority (ASA) has published two rulings on 16 April 2025. A complai...
Latest Life Sciences Practice Notes
Conducting clinical research—data protection implicationsData, and consequently data protection compliance, is central to conducting clinical research...
Confidential information, privacy and injunctionsThis Practice Note deals with the general principles of obtaining an injunction relating to...
Life sciences cases tracker—UKThis Practice Note is intended to be used to track the progress of UK cases relevant to the life sciences sector.Jump...
Outsourcing and data protectionIn briefData protection laws in the UK seek to ensure information about living individuals (within the definition of...
Brexit legislation trackerThis Practice Note tracks the progress of UK legislation introduced as part of the legislative project associated with the...
Latest Life Sciences Precedents
Option 1—deed executed by administrative receiver under the company’s common seal Executed as a deed by [insert name of company]...
Option 1—deed executed by liquidator under the company’s common seal ...
Material transfer agreementThis Agreement is made on [date]Parties1[Insert the company name] a company registered in [England and Wales] under company...
Clinical Research Organisation (CRO) master services agreementThis Agreement is made on [date]Parties1[Insert the company name] a company registered...
Protecting know–how—training materialsThese training materials consist of template PowerPoint slides that can be used as the basis of one or more...
Latest Life Sciences Q&As
Featured Life Sciences content
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...
Regulation of e-cigarettes...
Regulation of e-cigarettes31 December 2020 marked the end of the Brexit implementation period following the UK’s decision to withdraw from the EU. At...
Clinical evaluation and performance evaluatio...
Clinical evaluation and performance evaluation of medical devices in the EUThis Practice Note describes key changes to the requisite clinical...
Unlicensed medicinal products and off-label u...
Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
Second and subsequent medical use patent clai...
Second and subsequent medical use patent claimsBackground to medical use claimsSecond (and subsequent) medical use patent claims are specific to the...
Post-market surveillance of medical devices i...
Post-market surveillance of medical devices in the EUPost-market surveillance is the monitoring by manufacturers of medical devices to ensure their...
Intellectual property protection for medical ...
Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...
Medicines and Medical Devices Act 2021...
Medicines and Medical Devices Act 2021This Practice Note provides an overview of the Medicines and Medical Devices Act 2021 (MMDA 2021) which, in...
Introduction to borderline products...
Introduction to borderline productsThis Practice Note provides an introduction to the concept of borderline products, how the regulatory status of...
Clinical Research Organisation (CRO) master s...
Clinical Research Organisation (CRO) master services agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
Pharmacovigilance...
PharmacovigilancePharmacovigilance is the process of collecting and understanding information relating to the adverse effects of medicinal product...
The UK medical devices regime and the impact of the Northern Ireland Protocol...
Life Sciences analysis: Peter Rudd-Clarke, partner, and Anna Lundy, associate director, at Osbo...
Medical devices due diligence questionnaire...
Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
Life Sciences weekly highlights—11 August 2022...
This week's edition of Life Sciences weekly highlights includes analysis of the English court’s...
The regulation of advanced therapy medicinal ...
The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
The experimental use and Bolar-type exemption...
The experimental use and Bolar-type exemptions to patent infringementPatent systems are intended to foster innovation, not to impede it. For this...
Life Sciences weekly highlights—18 August 2022...
This week's edition of Life Sciences weekly highlights includes consideration of the arguments ...
Pharma and medical device regulation—Colombia...
Pharma and medical device regulation—Colombia—Q&A guideThis Practice Note contains a jurisdiction-specific Q&A guide to pharma and medical...
Associated legal terms
Bioequivalence
Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits.
Orphan medicinal product
A medicinal product that is used to prevent, diagnose or treat a rare medical condition or disease. In the EU, according to Regulation (EC) 141/2000, a disease is defined as rare if it affects fewer than 5 in 10,000 people across the EU.
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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