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Royal Decree 468/2026 amends RD 1345/2007 to require electronic registration for industrially manufactured medicinal products for human use. A new additional provision 7 is introduced, establishing a three-month implementation period from the date of entry into force. This change aims to modernise the control system and improve the traceability of pharmaceutical products (Art. 81.1, 84-86, additional provision 7).
For pharmaceutical companies, this entails an obligation to adapt their registration systems to an electronic format, with the risk of fines for non-compliance within the deadline. Health authorities will benefit from enhanced traceability. Advisors must inform clients of the new obligation and the relevant deadlines. Management system providers must prepare to integrate the new regulation.
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