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These days, the House of Representatives and the Senate continue their review of the draft Legislative Decree on safety features appearing on the packaging of medicines for human use, which was preliminary approved by the Council of Ministers last 30 August 2024.
As known, the draft Legislative Decree, which provides for the unique identifier and tampering prevention system to be affixed to the packaging of medicines for human use as of 9 February 2025, has caused considerable concern among pharmaceutical companies, which, in addition to calling for more clarity on how the new traceability system will be implemented, have highlighted the need for a reasonable transition period that provides for adequate timeframes for compliance with the new requirements.
Pending the conclusion of the Parliament's review, the deadline of 9 February 2025, remains firm as of today.
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