The Product Identification and Labelling for Pharmaceutical Products Guidance and Template document is intended for use by national drug regulatory authorities (NDRAs) alongside the Guidance Model Directive for Traceability Regulation Development (model directive) in developing pharmaceutical labelling and packaging requirements to advance supply chain security. The model directive helps countries think through in-country regulation and includes guidance in how to identify gaps and recognize areas of enhancement in line with the traceability implementation process. This document is intended to specify how to implement that regulation in accordance with good global practices that leverage GS1 standards.
Product identification and labelling requirements should reference existing regulations and statutory instruments such as ministerial orders on medicines control and packaging/labelling of the medicines in the country. Where such instruments do not exist, the NDRA should decide on the applicable country framework to regulate guidelines specified in this document.