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 Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on implementing changes to the advertising and promotion of...
Life sciences analysis: Ian Jones, partner of Gill Jennings & Every LLP, discusses the changes to marketing authorisations (MAs) and Supplementary...
This week's edition of Life Sciences weekly highlights includes news that the European Commission has fined Teva €462.6m for abusing its dominant...
The Association of British HealthTech Industries (ABHI) has published its response to the Medicines and Healthcare products Regulatory Agency’s (MHRA)...
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a joint statement with the Association of the European...
Latest Life Sciences Practice Notes
IP issues in 3D printingThis Practice Note introduces the IP issues which have an impact in 3D printing. It covers enforcement of patents, design...
Introduction to the EU GDPR and UK GDPRThis Practice Note provides an introduction to both the EU’s General Data Protection Regulation, Regulation...
Supply chains under data protection law—arrangements between controllers and processorsThis Practice Note introduces the requirements of the United...
Outsourcing and data protectionIn briefData protection laws in both the EEA (the EU plus Iceland, Norway, and Liechtenstein) and UK seek to ensure...
UK GDPR and EU GDPR—sanctions and enforcementThis Practice Note introduces the approach to sanctions and enforcement under:•the EU’s General Data...
Latest Life Sciences Precedents
Personal data sharing clause—controller to controller—pro-receiving partyDefined terms: This Precedent clause uses the additional defined terms...
Particulars of Claim—patent infringement claimCLAIM No: [insert claim number]IN THE HIGH COURT OF JUSTICEBUSINESS AND PROPERTY COURTS OF ENGLAND &...
Letter of claim—patent infringementLetter of claim—patent infringement[Alleged infringer’s name and address][Date]Dear [insert organisation...
Personal data processing schedule—short form—pro-processorThis precedent is drafted in contemplation of arrangements where the parties wish to insert...
Personal data processing schedule—short form—pro-controllerThis Precedent is drafted in contemplation of arrangements where the parties wish to insert...
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 evaluation of medical devices in the EU
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 use of medicinal products
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 claims
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 in the EU
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 devices
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 services agreement
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 Osborne Clarke discuss how the medical device industry is...
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 jurisdiction to decide COVID-related business...
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...
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...
Life Sciences weekly highlights—18 August 2022
This week's edition of Life Sciences weekly highlights includes consideration of the arguments put forward against DeepMind, Google’s subsidiary, for...
Pharma and medical device regulation—Colombia—Q&A guide
Pharma and medical device regulation—Colombia—Q&A guideThis Practice Note contains a jurisdiction-specific Q&A guide to pharma and medical device...
Associated legal terms
Generic
A medicinal product which contains the same active substances and has the same pharmaceutical form as the original branded reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies, as defined in Article 10(2)(b) of Directive 2001/83/EC.
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.
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
CONTACT US
