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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

Accelerated assessment

Many countries offer a regulatory pathway that will expedite the evaluation of certain medicinal products so that they reach patients faster. In the EU, the accelerated assessment procedure reduces the timeframe for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing authorisation (MA) application from 210 to 150 evaluation days. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation. In the UK, the Medicines and Healthcare Regulatory Agency (MHRA) offers a 150-day assessment timeline for all high-quality new MA applications in an effort to accelerate the availability of new medicines for patients in the UK. The MHRA evaluates the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland MA and reaches its opinion on whether to approve the licensing of new medicines within 150 days of submission of a valid application. See also: marketing authorisation (MA).

Marketing Authorisation

/ˈmɑːkɪtɪŋ/ /ɔːθərʌɪˈzeɪʃ(ə)n/

The approval needed to place a medicinal product on the market. It sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the holder of the marketing authorisation.

Originator

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.
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