Unlicensed medicinal products and off-label use of medicinal products

Produced in partnership with Dr Peter Feldschreiber of 4 New Square

Practice notes

Unlicensed medicinal products and off-label use of medicinal products

Produced in partnership with Dr Peter Feldschreiber of 4 New Square

Practice notes

This Practice Note explores unlicensed medicinal products and the various ways that such products may be made available to patients in the EU and UK, including through the UK’s Specials regime. The note goes on to consider the use of licensed medicinal products outside the terms of their authorisation (known as off-label use). Finally, this Practice Note considers liability issues concerning the unlicensed use of medicines.

The UK regulatory framework for unlicensed medicinal products has mainly originated from EU law. Many principles and Requirements derived from EU law have been maintained in UK domestic law, unless specific provisions stipulate otherwise. This Practice Note provides an overview of both the EU and UK regimes: considerations on EU legal requirements can be regarded as applicable to the UK regime unless UK provisions which diverge from EU legislation are explained separately. This Practice Note also explains relevant EU case law; for information on the extent to which UK courts and tribunals are bound by EU case law after the Brexit implementation

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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 European Law. He is co-author of the chapter on the regulation of healthcare products in Butterworths Healthcare Law and Practice/

He is retained counsel to a number of solicitors' firms and has experience of international litigation regarding drug induced injury. He has also published extensively on the law of causation and European regulatory procedure. He has published research into the repair of DNA following ionising radiation whilst working at the Institute of Cancer Research.

Jurisdiction(s):

United Kingdom

Key definition:

Specials definition

What does Specials mean?

Unlicensed medicinal products for human use which have been specially manufactured or imported to the order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for the treatment of individual patients in order to fulfil the special needs of an individual patient.

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