Headline: Italy‘s Delay in Adopting EU Drug Packaging Regulations Risks Medicine Shortages
Subheadline: Failure to comply with EU regulations on drug packaging could lead to medicine shortages in Italy starting February 2025.
Article:
Italy is lagging in implementing an important European regulation on drug packaging, with potential consequences for millions of Italian patients. From February 9, 2025, many commonly used medicines could disappear from pharmacy shelves due to the country’s delay.
The Italian government has yet to specify how it will transpose the 2011 EU directive, which aimed to create a unified system against drug counterfeiting and tampering. Although initially given a deroga, Italy’s delay has left the pharmaceutical industry uncertain about how to proceed.
Three Key Changes Required
The revision brings three significant changes to drug packaging:
- Datamatrix Code: A 2D barcode to be printed on every box, ensuring traceability and providing information about the product’s origin and expiration date.
- National Drug Registry: A database that cross-references data with the European registry to authenticate drugs.
- Security Seal: An inviolable seal to guarantee the box’s integrity.
Goverment’s Ambiguity
The Italian government approved a decree in August outlining general principles but provided no concrete guidance on implementation. Consequently, the entire pharmaceutical supply chain has united under the National Medicines Verification Organisation (Nmvo) to engage in dialogue with the government. However, significant obstacles remain:
- The decree’s confirmation by Parliament is pending, with a March deadline looming.
- Uncertainty about who will provide the security seals and how to manage old packaging.
This uncertainty has prevented manufacturers from adjusting their production lines to accommodate the changes. The Nmvo has requested a two-year transition period, but it remains unclear if the government can accommodate this request. If not, pharmacies could face severe medicine shortages starting in February 2025.
