Edited by Paola Furiosi and Francesca Caliri
On January 18th, Legislative Decree n. 218/2023 came into force. By aligning Italian legislation with that established by Regulation (EU) 2019/6, the Decree established the entry into force of the “New National Code of Veterinary Medicines”, with consequent repeal of the previous Code of 2006. In its 46 articles – and related annexes – the new legislative text, on the one hand, incorporates the European provisions already regulated by the abovementioned Regulation and, on the other, introduces ad hoc provisions for the matters left to the jurisdiction of the Member States, including those relating to stock retention, authorizations and management of the sanctioning system.
The principal innovations
In general, the innovations introduced by the new provisions are multiple and cover topics such as surveillance, controls and inspections, penalties for violations of both Italian and European rules, traceability, organization of the national pharmacovigilance system, methods of retail distribution, parallel trade, management of stocks by veterinarians, right of substitution by the pharmacist. However, the rules of Title III and Title IV of the provision, relating – respectively – to the rules for holding, supplying and using veterinary medicines (articles 17-30) and to the rules for managing stocks (articles 31-37).
As for Title III, firstly, it favors wholesale trade of veterinary medicines among Member States for marketing authorization holders. Furthermore, new issues such as the remote sale of non-prescription veterinary drugs and the retail distribution of generic drugs are dealt with, where the pharmacist, before concluding the purchase, is obliged to inform the user (so-called “substitution right”).
Specifically, with reference to this last point, the pharmacist is required to inform the buyer of the possibility of using a generic or equivalent drug when this is economically more convenient or in case the prescribed drug is not available. In this regard, in order to ensure transparency on the point, the Ministry of Health has made available on its website the first list of equivalent veterinary medicines, subject to public consultation until January 31, 2024, deadline by which the marketing authorization holders could suggest additions and observations. Once this phase has concluded, the “transparency lists” will be officially published on the portal and made available to anyone interested.
With respect to the provisions referred to in Title IV, the new rules on the dispensation of medicines by veterinarians deserve particular attention. To start the prescribed therapy and ensuring the immediate protection of animal welfare, the veterinarian may hand over medicines from his own stock to the breeder or owner of animals, as well as single fractions of multiple packages that can be distributed individually, provided that each fraction is equipped with a leaflet or other electronic support. Such dispensations will not enjoy any exemption in tracking activities and, consequently, veterinarians will be required to record in the traceability information system all the drugs delivered to their customers, within 7 days from such dispensation.
Finally, among the various provisions on sanctions, it is noted the introduction of penalties for pharmacies that do not make their premises and equipment accessible at all times to the personnel in charge of inspecting them, as well as penalties applicable if they do not use – both in the procurement phase and in the distribution phase – systems or equipment suitable to ensure the correct conservation of veterinary medicines. In this case, the administrative penalty imposed by the competent Authority may amount to a maximum of about 30,000 Euros.
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