This chapter explains the application of the Product Liability Directive in the case of off-label use of medicinal products. In particular, it considers the concept of off-label use, including its background and place in clinical practice, the Product Liability Directive and its main provisions, the liability of the producer under the Product Liability Directive in the case of off-label use, and the liability of the prescribing physician and the pharmacist.

This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.