Italy: Preliminary approval of the Legislative Decree on the packaging of medicinal products for human use

September 2024

In brief

On 30 August, the Council of Ministers preliminary approved the draft Legislative Decree for adapting the Italian legislation to the provisions of Delegated Regulation (EU) 2016/161, supplementing Directive 2001/83/EC by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.


Contents

Key takeaways 

In particular, the draft Legislative Decree provides for the harmonization of existing national rules to the provisions of the Delegated Regulation through the introduction of specific and progressive measures to ensure, by 9 February 2025, the placing of the unique identifier and anti-tampering device on the packaging of medicinal products aimed at verifying the integrity of the primary or secondary packaging of the medicine, the adjustment of procedures for market surveillance and safety control of medicines, the establishment and management of the national repository containing information on the safety characteristics of medicines and the definition of the relevant sanctioning system, through the provision of administrative penalties. Transitional provisions are also introduced to regulate the distribution and supply of medicines whose batches have been released by 9 February 2025 with the pharmaceutical sticker.
 


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