Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Medicinal Product definition

What does Medicinal Product mean? In legal practice, a medicinal product is any substance or combination presented as treating or preventing disease in humans, or administered to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis. The term is defined in legislation: in Great Britain by the Human Medicines Regulations 2012, and in EU law by Directive 2001/83/EC (applicable in Ireland and, for most human medicines, in Northern Ireland under the Windsor Framework). Usage is materially consistent across England & Wales, Scotland, Northern Ireland and Ireland. Classification applies a two‑limb test: presentation (does it claim to...

EU and UK Medicinal Products Regulation: Marketing Authorisations, Clinical Trials, Regulatory Data/Market Exclusivity, Pharmacovigilance, Advertising, Pricing and Reimbursement, Biosimilars, ATMPs, Orphan and Paediatric Regimes, and Northern Ireland/Windsor Framework

Published by a LexisNexis Life Sciences expert

Practice notes

EU and UK legal framework governing medicinal products

A detailed network of obligations and guidance at EU, EU member state and UK levels governs critical aspects of medicinal products, including:

clinical investigation (clinical trials)
market entry (marketing authorisation (MA), approval procedures and variations to those MAs)
protection of pre-clinical and clinical data (regulatory data protection)
manufacture and importation
labelling and the package leaflet
advertising and promotion
wholesale distribution and brokering
pharmacovigilance
pricing and reimbursement
falsified medicines
medicines for rare diseases (orphan medicinal products (OMPs))
paediatric medicines
advanced therapy medicinal products (ATMPs)
unlicensed medicines and off-label use of authorised medicines

EU legislation in these fields has expanded rapidly, resulting in greater harmonisation across numerous areas. Nevertheless, Requirements and guidance at the level of individual EU Member States remain fundamental to the overall regulatory framework. Notably, there are significant variations between Member States in how they interpret, apply and enforce these rules...

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Web page updated on 21/05/2026

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