Reporting of temporary shortages of veterinary products

    Last update Updated on 14/3/2024

    The Marketing Authorization Holder must notify temporary cessation of the marketing of the veterinary medicinal products to the Ministry of Health; this communication, save in exceptional circumstances, must be received at least sixty days before the interruption, pursuant to Article.16, co.5 of the Legislative Decree no. 218, 7 December 2023.

    MAHs, their legal representatives or persons or companies delegated by them, located in the European Union.

    Filled reporting form of temporary shortages of veterinary medicinal products.

    Modulo Carenze.pdf

    PEC
    Certified email (PEC)
    :
    dgsa@postacert.it
    Email subject:
    Reporting form for veterinary medicinal products
    Email
    Email of the receiving office
    :
    VMP-availability@sanita.it
    Email subject:
    Reporting form for veterinary medicinal products

    No time range forseen.

    Through online payment via the integrated Online Payment connected with PagoPA

    Non è prevista la comunicazione dell'esito

    Not present

    Legislative Decree no. 218, 7 December 2023 "Adaptation of national legislation to the provisions of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC, pursuant article 17 of  law 4 agosto 2022, n. 127".


    Consulta il Trovanormesalute

    Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
    Ufficio 4 - Medicinali veterinari

    Vincenza Giuseppina Azzarà
    Via Giorgio Ribotta, 5 - 00144 Roma

    Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)