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Royal Decree 468/2026 amends RD 1345/2007 to require electronic registration of industrially produced human medicines. A new Additional Provision 7 sets a three-month implementation period from the decree's entry into force, aiming to modernise control and improve product traceability (arts. 81.1, 84-86, disp. ad. 7).
Pharmaceutical manufacturers must transition to electronic submission processes within three months of implementation. Health authorities will receive digital applications, enhancing traceability and operational efficiency. Applicants without electronic access will no longer be able to submit physical applications. The change has no impact on end users or distribution centres.
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