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.
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.
This content includes guidance on marketing authorisations, orphan and paediatric medicines, pharmacovigilance, manufacturing, unlicensed and off-label medicines.
Covering key areas of medical devices regulation including classification, conformity assessments, clinical and performance evaluation as well as post-market surveillance.
The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation seeking stakeholder feedback on the operation and impact of...
The European Parliament’s Policy Department for Justice, Civil Liberties and Institutional Affairs has published a study examining the EU’s regulatory...
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that the application date for groundbreaking new UK legislation has...
The European Financial Reporting Advisory Group (EFRAG) has launched its 'EFRAG 2025 State of Play' portal, providing analysis of the first 656...
The European Commission has published an Explanatory Notice and Template to guide providers of general-purpose AI (GPAI) models in meeting their...
UK Rome II—application and interpretationThis Practice Note is for use when determining applicable law in the courts of England and Wales respect of...
Product liability and defective productsThis Practice Note summarises the law on product liability and defective products under the Consumer...
Trade secrets and confidential information—protection and enforcementThis Practice Note sets out the protection available for trade secrets and...
Anti-counterfeiting in the UKThis Practice Note summarises the main types of legal action that can be taken against the UK trade in counterfeit goods,...
IP issues in 3D printingThis Practice Note introduces the IP issues which have an impact in 3D printing. It covers enforcement of patents, design...
Material transfer agreementThis Agreement is made on [date]Parties1[Insert the company name] a company registered in [England and Wales] under company...
Declaration of a director’s interests in an existing transaction or arrangement—general noticeThe Directors[Insert name of company][(Company)][Insert...
Declaration of a director’s interests in a proposed transaction or arrangement—general noticeThe directors[Insert name of company] ([Company])[Insert...
Declaration of a director’s interests in a proposed transaction or arrangement—notice in writingThe directors[Insert name of...
Briefing for directors—general duties under the Companies Act 2006Every director of a company owes a number of duties to the company they are...
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 UKThis Practice Note provides an overview of the UK regulatory framework for cosmetics. It sets out the legal...
Intellectual property protection for medical devicesChanges to intellectual property (IP) law from 1 January 2021Before discussing how intellectual...
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 infringementPatent systems are intended to foster innovation, not to impede it. For this...
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 agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
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 questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
Biotechnology patentsPatenting biotechnological inventionsBiotechnological inventions are, in principle, patentable. While there is no general...
Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
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 UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
The National Archives has published the judgment in British Standards Institution v RRR Manufacturing Pty Ltd, R (on the application of) [2024] EWCA...
The Competition and Markets Authority (CMA) has announced a Phase 1 merger inquiry into Roche Diagnostics Ltd's acquisition of point-of-care testing...
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 productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
Generally, active implantable medical devices (AIMDs) are powered devices (other than from the human body or gravity) that are inserted into a patient’s body partially or fully through a natural orifice or by surgical means, and are intended to remain in the patient’s body. For example, coronary pacemakers, cochlear hearing implants, infusion pumps or neurostimulators. The UK and EU legislative definitions differ and are as follows: The UK Medical Devices Regulations 2002 (MDR 2002), SI 2002/618, which implement Directive 90/385/EEC, the Active Implantable Medical Devices Directive in the UK, define AIMD as: ‘…a medical device which— • relies for its functioning on a source of electrical energy or a source of power other than that generated directly by the human body or by gravity; and • is intended to be totally or partially introduced into the human body (whether surgically or medically, including being introduced into a natural orifice) and which is intended to remain in the human body after completion of the surgical or medical procedure during which it is introduced, even if it is intended to administer a medicinal product or incorporates as an integral part a substance which, if used separately, would be a medicinal product.’ Under Regulation (EU) 2017/745, the Medical Devices Regulation (EU MDR), an active device and an implantable device are separately defined: ‘…active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device.’ ‘…implantable device means any device, including those that are partially or wholly absorbed, which is intended: • to be totally introduced into the human body, or • to replace an epithelial surface or the surface of the eye by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.’ Specific requirements for AIMDs are set out in Annex I of the EU MDR at Chapter 2, section 19.
Making a medicinal product that would normally require authorisation'>marketing authorisation available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product.
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.