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...

Orphan Medicinal Products: EU and UK Regulatory Frameworks—Designation, Authorisation, Market Exclusivity, Derogations, Key Case Law and Forthcoming Reforms

Published by a LexisNexis Life Sciences expert

Practice notes

(OMPs) are medicines that help prevent, identify or treat rare illnesses and medical conditions. Because the number of people affected is very small, without incentives, pharmaceutical companies may doubt whether sales would cover the research and development (R&D) costs of medical products to detect, prevent and treat such disorders. In the relevant EU law, 'rare' is defined as affecting fewer than five in 10,000 people in the EU. Yet most rare conditions impact fewer than one in 100,000 people. Although each individual rare disease is uncommon, they carry major public health importance and significance. There are thought to be more than 6,000 distinct rare diseases; so, while each is infrequent on its own, together they account for a substantial patient population, roughly one in every 12 people in the EU (all rare diseases combined). In the absence of incentives, it is frequently not commercially feasible for pharmaceutical companies to develop and market OMPs, and only about 5% of rare diseases currently have an authorised treatment option available...

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Sarah Faircliffe

Bird & Bird

Sarah works as a Legal Director in London, as part of Bird & Bird’s Life Sciences and Healthcare Group. With over twenty years of experience, she advises clients on EU and UK laws, guidance and codes of practice concerning the regulation of medicines, medical devices and related areas. In 2022, Sarah was short-listed for the Advisory Lawyer of the Year at the LMG Life Sciences Awards, and she was also part of the winning team for the “Impact Case of the Year” at the same awards.Having spent 10 years as a Legal Adviser at the European Medicines Agency (EMA), Sarah brings a wealth of industry and policy knowledge to her role, offering unique insight into the law and procedures governing medicines regulation. During this period, she advised the EMA and its scientific committees on a wide range of legal issues. She played a key role in...

Web page updated on 21/05/2026

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