The European Medicines Agency (EMA), via the Coordination Group for Mutual Recognition and Decentralised Procedures—Human (CMDh), has issued the final revision of the guidance “Mobile scanning and other technologies in the labeling and/or package leaflet of centrally authorised medicinal products – General principles of acceptability and rules of procedure” (Rev 2, 23 March 2026). The guidance clarifies how technologies such as QR codes, 2D barcodes, and other digital?labeling solutions can be used in the product information (SmPC) and/or forms of the package leaflet for centrally authorised medicines, including aspects of acceptability, data?linking, and risk?mitigation. It provides conditions under which dynamic or external?hosted content (e.g., web?based ePI, digital patient information) may be linked from the pack, alongside requirements for availability, language, and technology?neutral access.
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