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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.

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Associated legal terms

Active pharmaceutical ingredient (API)

Also referred to as a ‘drug substance’, this term refers to any substance or mixture of substances intended to be the biologically active ingredient (or ‘active substance’) contained in a final medicinal product and intended to provide pharmacological activity or other direct effects. It is internationally defined as: ‘…any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.’ Medicinal products are usually composed of several components: the primary biologically active ingredient(s) which form the active pharmaceutical ingredient (API) plus other non-active ingredients known as ‘excipients’. The procedure for optimising and compositing this mixture of components, often producing ‘pharmaceutical intermediate’ byproducts as synthesising the API, and excipients into a final medicinal product is referred to as drug ‘formulation’. APIs are legally required to be registered with drug regulatory authorities (eg MHRA, FDA, EMA) and manufactured in compliance with good manufacturing practice (GMP) regulations and licensed facilities.

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.

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.
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