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
This week's edition of Life Sciences weekly highlights includes news analysis by Shoosmiths LLP of the Court of Appeal’s ruling in a closely watched...
The Medicines and Healthcare products Regulatory Agency (MHRA) has set out plans for a new five-year strategy designed to strengthen its position as a...
The Advisory Council on the Misuse of Drugs (ACMD) has launched a consultation to review the impact of 2018 changes to the Misuse of Drugs Regulations...
IP analysis: In a closely watched dispute over mRNA vaccine technology, the Court of Appeal upheld the validity of European Patent (UK) No 3 590 949...
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a blog outlining the implementation of the new Decentralised...
Latest Life Sciences Practice Notes
Life sciences cases tracker—EUThis Practice Note is intended to be used to track the progress of EU cases relevant to the life sciences sector.Jump...
Jurisdiction agreements—approach of the courts of England and WalesThis Practice Note looks at the approach of the English courts when determining the...
Retained EU law and assimilated lawThis Practice Note provides an overview of retained EU law as it applied from 2021–23, including the key...
AI in life sciences and digital health tracker—UKThis Practice Note tracks key legislative and regulatory developments, government initiatives and...
UK Rome II—application and interpretationThis Practice Note is for use when determining applicable law in the courts of England and Wales respect of...
Latest Life Sciences Precedents
Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
Confidentiality agreement—one-way—pro-discloserThis Agreement is made on [date]Parties1[Insert name of party][ of [insert details] OR a company...
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 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
Advanced therapy medicinal product
Also known as an ATMP, a medicinal product for human use that is based on genes, tissues or cells. There are three types of ATMP: - gene therapy medicines - somatic cell therapy medicines - tissue engineered medicines.
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.
Off label
The intentional use of an authorised medicinal product outside the terms of its authorisation'>marketing authorisation (e.g. for a different indication, different dose or in a different patient population). It is considered off-label use of a medical device if the device is used differently from how the manufacturer has instructed.
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