EU Falsified Medicines Directive mandatory requirements for secondary care: A concise review

Abstract

Since the publication of the Falsified Medicines Directive in 2011 and the subsequent delegated regulation in February 2016, there has been much discussion surrounding the level of Falsified Medicines Directive compliance required by secondary care institutions. Due to the heterogeneous nature of the secondary care drug distribution cycle, the Falsified Medicines Directive allows certain dispensations for ‘healthcare institutions’, this manuscript reviews the Falsified Medicines Directive and delegated regulation in an effort to understand and explain these dispensations and the true impact of the Falsified Medicines Directive on secondary care in an effort to address common misconceptions amongst stakeholders.