Italy has implemented a significant update in its legislation concerning veterinary medicines with the enforcement of Legislative Decree 218/2023, already in force. This decree marks a pivotal shift, aligning the national framework with the regulations outlined in the EU Regulation 2019/6 on Veterinary Medicines while repealing the previous Legislative Decree 193/2006.

The culmination of extensive parliamentary deliberations and executive efforts spanning two legislative sessions, the new decree reflects a concerted effort to modernize and adapt Italy’s veterinary medicine regulations to meet European standards.

Key provisions of the decree include:

Broader Access to Veterinary Products

Notably, the decree expands access to veterinary products, particularly antiparasitic and disinfectant treatments for companion animals. This change allows retail sales in commercial establishments beyond pharmacies, provided there is no requirement for a veterinary prescription.

Enhanced Consumer Protection

In response to parliamentary and public concerns, the decree mandates the publication of administrative measures on the Ministry of Health’s official website regarding the blocking of illegal online platforms selling veterinary medicines. This measure aims to safeguard consumer interests and regulate the veterinary medicine supply chain.

Regulation of Antimicrobial Use

The decree introduces stricter regulations governing the use of antimicrobials in veterinary practices, emphasizing prudent and responsible usage. It outlines guidelines for antimicrobial administration in prophylactic and metaphylactic contexts, aiming to curb antimicrobial resistance and promote animal welfare.

Streamlined Dispensing Practices

Efforts to simplify dispensing procedures are evident in the decree, with provisions allowing veterinarians to distribute veterinary medicines in fractions accompanied by electronic or physical package inserts. This aims to facilitate immediate therapy initiation while ensuring animal welfare.

Sanction Reforms

Recognizing the need for proportionate penalties, the decree revises sanctioning mechanisms, reducing excessively high fines previously stipulated. This adjustment seeks to maintain regulatory compliance while mitigating undue financial burdens on stakeholders.

While the decree addresses several key concerns raised during parliamentary discussions, some proposals, such as provisions for wholesale distribution of veterinary medicines, were not incorporated. Additionally, certain aspects, including regulations on donations of veterinary medicines, remain unaddressed. In conclusion, the enactment of Legislative Decree 218/2023 represents a significant milestone in Italy’s veterinary medicine regulations, fostering alignment with EU standards while addressing pertinent issues in consumer protection, antimicrobial stewardship, and retail sales.