The Decree of 16 June 2026 was published in the Official Gazette, updating the operating procedures of the Central Database for the monitoring of medicinal packs within the distribution system.
The measure incorporates the provisions of Delegated Regulation (EU) 2016/161 and Legislative Decree No. 10 of 6 February 2025, integrating into the Central Database the new information relating to the unique identifier of medicinal packs.
The new framework is intended to ensure the continuity of monitoring medicinal product distribution and pharmaceutical expenditure borne by the National Health Service (SSN), while further strengthening the traceability of medicinal packs throughout the supply chain.
SCF has prepared a Focus aimed at providing an overview of how the Central Database operates under the new regulatory framework, with a particular focus on the stakeholders involved, data submission processes, and the information to be reported.
