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 Health Research Authority (HRA) has launched a new three-year strategy, to support the UK government’s health and economic growth missions. The...
This week's edition of Life Sciences weekly highlights includes news that the Commission launched a new strategy to make Europe a global leader in...
The European Commission has found Achem guilty of participating in a drug ingredient cartel for more than a decade after the drugmaker previously...
The European Commission has launched a consultation on proposed updates to EudraLex Volume 4: Good Manufacturing Practice (GMP) guidelines. Feedback...
The European Commission has published its EU Stockpiling Strategy as part of the broader Preparedness Union Strategy. The strategy is designed to...
Drafting for unforeseen events—commercial contractsThis Practice Note provides practical guidance for general commercial practitioners on points to...
Exclusion and limitation of liabilityThis Practice Note considers exclusion and limitation of liability in business-to-business (B2B) contracts. It...
Virtual execution of documentsThis Practice Note provides practical guidance on how to execute documents properly when one or more parties to a...
Execution formalities—overcoming impairments, disabilities and language barriersThis Practice Note provides practical guidance on how to arrange the...
Execution formalities—witnessesThis Practice Note summarises the execution formalities for witnesses, including who can act as a witness to the...
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...
Confidentiality letter—one-way—pro-recipient[insert address of sender]Our ref: [insert reference]Your ref: [insert reference][insert address of...
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.
An investigation conducted in human subjects which aims to discover or verify the effects of and adverse reactions to a medicinal product, ie, it assesses a medicine’s efficacy and safety.
Another term for reference medicinal product, which has been granted a authorisation'>marketing authorisation (MA) on the basis of a complete dossier in accordance with Articles 8(3), 10a, 10b or 10c of Directive 2001/83/EC, and to which the application for MA for a generic medicinal product refers, by demonstration of bioequivalence.