Unlicensed medicinal products and off-label use of medicinal products
Produced in partnership with Peter Feldschreiber, 4 New Square, Lincolns’ Inn
Unlicensed medicinal products and off-label use of medicinal products

The following Life Sciences practice note produced in partnership with Peter Feldschreiber, 4 New Square, Lincolns’ Inn provides comprehensive and up to date legal information covering:

  • Unlicensed medicinal products and off-label use of medicinal products
  • An introduction to unlicensed medicinal products and off-label use of medicinal products
  • Named patient exemption
  • UK Specials regime
  • The ‘special needs’ test
  • Manufacturing of Specials
  • Import, export and distribution of Specials
  • Advertising of Specials
  • Unlicensed cannabis-based products
  • Compassionate use—EU regime
  • More...

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 period, see Q&A: Are UK courts and tribunals bound by decisions of the Court of Justice of the European Union post-Brexit?

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

In the EU, Article 6 of Directive 2001/83/EC (consolidated version 26.07.2019), the Pharmaceutical Code establishes the general rule that no medicinal product may be placed on the

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