Italy: Serialization of medicines - the 9 February 2025 deadline to comply with European standards

In brief

The deadline of 9 February 2025 to adapt Italian legislation to the provisions of Delegated Regulation (EU) 2016/161 on serialization of medicines requires a real race against time by pharma companies and all stakeholders.


Contents

Key takeaways

According to the draft legislative decree preliminarily approved by the Council of Ministers on 30 August 2024, pharma companies should file with the Italian Medicine Agency (AIFA) the updated version of the leaflet and SmPCs of their medicines by 9 November 2024, in compliance with the requirements of Article 78 of the Drugs Code, which provides for a silence/assent mechanism after 90 days.

Farmindustria and Egualia expressed perplexity about these deadlines and requested postpone the deadline of at least 18 months from 9 February 2025, due to the need to amend the draft legislative decree approved by the government on a preliminary basis.

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