Veterinary drugs, decree in the Official Journal in force from 18 January 2024

In 46 articles and 5 annexes, the legislative decree of 7 December 2023, n. 218 adapts the national legislation to regulation (EU) 2019/6 on veterinary medicinal products.

The decree is published in the Official Journal and will come into force on 18 January 2024, repealing the previous Italian legislation, Legislative Decree 193/2006.

The new decree, drawn up following the legislative principles dictated by the European delegation law, regulates the matters that the European Union leaves to the power of the Member States (e.g. stocks, distribution, sanctions, etc.) and is accompanied by the rules of Regulation (EU) 2019/6 applicable to Italy as early as 28 January 2022
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Legislative decree 218/2023 does not cover some aspects of the management of veterinary medicinal products, including the so-called cascade, for which the European rules apply.

The provision regulates marketing authorizations and clinical trials , dictates manufacturing standards, controls and inspections.

The text contains specific provisions for homeopathic medicinal products (In the absence of availability of registered homeopathic veterinary medicinal products, a registered homeopathic medicinal product for human use may be prescribed) and for the advertising of veterinary medicinal products (immunological veterinary medicinal products may be advertised ' also aimed at professional breeders).

The national pharmacovigilance system , managed by the Ministry of Health, is interconnected and integrated with the European Union pharmacovigilance system.

The most substantial body of legislation concerns the rules for the possession, supply and use of veterinary medicines (articles 17 to 30) and the rules for managing stocks (articles 31 to 37).
Article 29 strengthens the rules for the rational use of antimicrobials , providing for the adoption of national guidelines for use in prophylaxis and metaphylaxis and regulating combinations of medicines.

The observations discussed in Parliament during the examination of the first text proposed by Palazzo Chigi have been partially implemented in the new decree. These include the possibility of retailing veterinary medicines with an anti-parasitic and disinfestant action for external use and for oral use even in commercial establishments other than pharmacies, as long as there is no veterinary prescription requirement.

The transfer of veterinary medicines was only partially modified by the Government following the parliamentary examination, while the proposal to create an ad hoc rule for the donations of veterinary medicines which could find its own regulation in a dedicated ministerial provision did not find space.

For the purposes of containing pharmaceutical expenditure, the pharmacist, before the sale, informs the user of the possibility of using a generic or equivalent veterinary medicinal product, when this is more economically convenient or when the prescribed veterinary medicinal product is not available in the distribution channel.

The first public list of equivalent veterinary medicines has been prepared by the Ministry of Health and is open for consultation until January 31st. (Source: https://www.anmvioggi.it/ )


LEGISLATIVE DECREE 7 December 2023, n. 218
Adaptation of national legislation to the provisions of Regulation (EU) 2019/6 which repeals Directive 2001/82/EC, pursuant to article 17 of law 4 August 2022, n. 127.
Annex I
Types of veterinary medicines whose administration must only be carried out by a veterinary surgeon.
Annex II
Method of use of the optically readable identification code on the individual packages of veterinary medicines placed on the market.
Annex III
Technical documentation to be attached to the application for simplified authorization of veterinary medicinal products
Annex IV
Traceability information system
Annex V
Advertising of veterinary medicines to the public.