Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Specials definition

What does Specials mean? In practice, specials are unlicensed medicines prepared or imported to meet an individual patient’s special clinical needs where no suitable licensed alternative is available or appropriate. In the UK, the concept and conditions are set out in the Human Medicines Regulations 2012, notably the “specials” exemption (regulation 167) and MHRA guidance. Key features include: a patient‑specific order from an authorised prescriber (doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber); manufacture or import by a holder of a specials manufacturing/import licence to GMP standards; appropriate labelling and record‑keeping; no advertising or general marketing; and use driven by clinical need...

UK and EU regulation of unlicensed and off-label medicines: Specials, EAMS, NIMAR, compassionate use, supply, advertising, case law and liability

Published by a LexisNexis Life Sciences expert

Practice notes

This Practice Note examines unlicensed medicines and the routes by which they can reach patients across the EU and the UK, such as via the UK Specials regime. It then looks at deploying authorised medicines beyond the scope of their licence (commonly termed off-label use). Lastly, the Practice Note addresses liability questions linked to using medicines without a licence. The UK’s regime governing unlicensed products is largely rooted in EU legislation. Numerous EU-derived principles and obligations remain in UK domestic law, save where particular measures provide otherwise. The Note surveys both EU and UK frameworks: analysis of EU Requirements should be treated as relevant to the UK system unless distinct UK rules departing from EU law are set out separately. It also summarises pertinent EU case law; for guidance on the extent to which UK courts and tribunals are bound after the Brexit Implementation period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit? The discussion covers availability routes, authorisation status, scope of permitted use, and resulting liability under applicable law in both jurisdictions where relevant and explained.

An introduction to unlicensed medicinal products and off-label use of medicinal

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Dr Peter Feldschreiber

4 New Square

Dr. Peter Feldschreiber is dually qualified as a barrister and physician. He specialises in medical and healthcare law including medical products liability, pharmaceutical and medical devices regulatory law, clinical negligence and personal injury and medically related employment litigation. Casework includes the Aspirin Reyes Syndrome product liability litigation, Atomic Veterans Litigation, the morning after pill litigation, the Seroquel litigation, Foetal Anti-convulsant Syndrome Litigation, Cochlear Implants and Cardiac Stent Litigations and judicial review and references to the ECJ on pharmaceutical regulatory issues. He has held appointments as Senior Medical Assessor and Special Litigation Coordinator to the Medicines and Healthcare products Regulatory Agency, Department of Health. Dr Feldschreiber is General Editor of The Law and Regulation of Medicines (Oxford University Press) and is Consultant Editor for the Volume on Medical Products for Halsburys Laws of England and the Lexis Nexis series on updates of UK and...

Sally Shorthose

Bird & Bird

As one of our firm's most experienced intellectual property partners, specialising in transactional IP matters, Sally offers a wealth of knowledge to businesses at the cutting edge of research, development and technology, in a variety of sectors for which IP is of prime importance.As a transactional IP lawyer, Sally provides advice on the protection and exploitation of IP rights, both in standalone transactions and as part of acquisition, divestment or investment activity. She leads the team delivering licensing, partnering and exploitation agreements, and research, development and marketing collaborations. She also advises our clients on regulatory and 'freedom to operate' issues and manage significant due diligence matters. Sally is joint head of the International Life Sciences Regulatory Group.Before joining Bird & Bird in 2006, Sally was head of IP & Life Sciences at another global law firm, after spending 11 years in-house firstly as senior legal...

Web page updated on 22/05/2026

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