Ministero della Salute

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Last modified date: 10 May 2024

Reporting of temporary shortages of veterinary products


ProcedureProcedure

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.


Who can apply?Who can apply?

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


What do I need?What do I need?

Filled reporting form of temporary shortages of veterinary medicinal products.

Reporting form for veterinary medicinal products.pdf


Application form and guidelinesApplication form and guidelines

  • Reporting form for veterinary medicinal products (formato pdf)

How can I apply?How can I apply?

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

How long does it take?How long does it take?

No time range forseen.


How much does it cost?How much does it cost?

not present


How do I know the outcome?How do I know the outcome?

not present


Outcome PublicationOutcome Publication

not present


Relevant lawRelevant law

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

Contact usContact us

  • Referent Name: Vincenza Giuseppina Azzarà
    Address: Via Giorgio Ribotta, 5 - 00144 Roma
    Telephone: 06.59943972
    Email: vg.azzara@sanita.it

Referent Office for Legal proceedingsReferent Office for Legal proceedings

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



TemiThematic Site


Referent Office for Legal proceedingsOffice