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 guidance 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
  • Compassionate use
  • Early access to medicines scheme (EAMS)
  • Exemptions under Article 3 of the Pharmaceutical Code
  • Miscellaneous exceptions under the Human Medicines Regulations 2012
  • Off-label use of licensed medicines
  • Off-label use case study—Avastin (bevacumizab)
  • more

On 31 January 2020, the UK ceased to be an EU Member State and entered an implementation period during which it continues to be treated by the EU as a Member State for many purposes. As a third country, the UK can no longer participate in the EU’s political institutions, agencies, offices, bodies (except to the limited extent agreed), but it continues to be subject to EU law and must submit to the continuing jurisdiction of the Court of Justice of the EU in accordance with the transitional arrangements in Part 4 of the Withdrawal Agreement. For further reading, see: Brexit—Life Sciences and News Analysis: Brexit Bulletin—key updates, research tips and resources.

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 EU market without first having been granted a marketing authorisation (MA) by the relevant competent authority (ie the European Commission in the case of centrally authorised medicinal products or a national competent authority in the case of decentralised, mutual recognition or purely national authorisation procedures). See Practice Note: Marketing authorisations—regulatory procedures for approval of medicinal products. In the UK, the Pharmaceutical Code is implemented by the Human Medicines Regulations