ABSTRACT
The role of medicines information Medicine package lea ets (PLs) are mandatory for packaged medicines in European Union member states. European law requires them to be ‘written and designed to be clear and understandable, enabling the user to act appropriately’ (European Parliament 2004). Guidance has been issued by European regulatory authorities (European Commission 2009), including a model text (EMA 2013), but this does not give specic advice about clear design. There is other published advice, but not much that is specic to PLs (MHRA 2005; Sless and Shrensky 2007; Raynor and Dickinson 2009; Dickinson et al. 2010).
