11. The Regulation of Medicines

Abstract

All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate; providing students with a stand-alone resource. This chapter examines the regulation of medicines. It first explains what a medicine is and the need for it to have a marketing authorization before it can be put into circulation. It covers the importance not only of establishing safety and efficacy before licensing, but afterwards as well, through pharmacovigilance mechanisms. The chapter covers the increasing European harmonization of the rules covering the licensing and marketing of medicines, and briefly discusses the implications of Brexit. Finally, it looks at liability for defective medicines, and the strict liability regime under the Consumer Protection Act.