The management of pharmaceutical labelling is a complex process involving multiple stakeholders. The printed package leaflets (PLs) or package inserts are enclosed in the medicinal package and serve as the primary source of information for the end users. Therefore, any changes to product labelling should be implemented promptly. This ensures that the new or updated safety information reaches patients and prescribers in an appropriate timeframe, and that any risk to patient safety is minimised. However, the standard approach of updating physical labels is labour-intensive, time-consuming, expensive and contributes negatively to the environment.

Recently, electronic labelling (e-labelling) has emerged as a revolutionary initiative in the healthcare sector. The implementation of e-labelling will not only drive efficiencies but will also overcome the limitations and logistical challenges associated with paper-based labelling. Overall, e-labelling will enable the harmonisation of concepts, approaches, processes, strategies and standards for labels globally.