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
Law360, London: Pfizer asked an appeals court on 10 July 2025 to revoke surplus patent protections underpinning rival Moderna's mRNA vaccine after...
Medicines for Europe has applied to intervene in legal proceedings before the EU General Court challenging the EPR scheme in the recast Directive...
The European Medicines Agency (EMA) has published its first AI Observatory report and supporting documents on 10 July 2025. The report compiles...
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to amend the Medical Devices Regulations 2002, SI 2002/618 to...
The Medical Device Coordination Group (MDCG) has published position paper MDCG 2025–7, which outlines the implementation timelines for the Master...
Latest Life Sciences Practice Notes
Brexit—implications for data protection [Archived]ARCHIVED: This archived Practice Note provides information on the Data Protection, Privacy and...
PharmacovigilancePharmacovigilance is the process of collecting and understanding information relating to the adverse effects of medicinal product...
Orphan medicinal productsOrphan medicinal products (OMPs) are medicines used to prevent, diagnose or treat rare medical conditions and diseases. Given...
Post-Brexit transition period—the regulation of medicinal productsThis Practice Note deals with key issues that affect marketing authorisations (MAs)...
Life sciences tracker—EU 2019–2022 [Archived]ARCHIVED: This Practice Note has been archived and is no longer maintained. It tracked the progress of EU...
Latest Life Sciences Precedents
Boilerplate set—short form1Definitions and interpretation1.1In this Agreement:[Insert each definition bespoke to the Agreement]1.2In this...
Manufacturing agreement—pro-customerThis Agreement is made on [insert date]parties1[insert name of customer ][of OR a company incorporated in [England...
Manufacturing agreement—pro-manufacturerThis Agreement is made on [insert date]parties1[insert name of manufacturer ][of OR a company incorporated in...
Template agreement—mutualThis Agreement is made on [date]Parties1[insert name of Party A][ of OR a company incorporated in [England and Wales] under...
Letter of claim—patent infringementLetter of claim—patent infringement[Alleged infringer’s name and address][Date]Dear [insert organisation...
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.
Marketing Authorisation
The approval needed to place a medicinal product on the market. It sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the holder of the marketing authorisation.
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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