Ministero della Salute

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Last modified date: 21 February 2022

Authorization of variations requiring assessment (VRA) to the terms of a MA for a veterinary medicinal product already granted via the national procedure


ProcedureProcedure

Variations requiring assessment (VRA) to the terms of the marketing authorization for a veterinary medicinal product granted via the national procedure are authorized upon application accompanied by all the administrative information and the technical and scientific documentation required by current legislation.


Who can apply?Who can apply?

Marketing authorization holders of veterinary medicinal products, their legal representatives or delegated persons or companies.


What do I need?What do I need?

Variation application with duty stamp accompanied by:

  • proof of the payment of the fee;
  • eApplication form completed in the relevant parts.

Application form and guidelinesApplication form and guidelines


How can I apply?How can I apply?


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

30-60-90 days according to the type, subject to a possible suspension of time limit.


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

Rate: https://www.salute.gov.it/imgs/C_17_pagineAree_527_1_file.pdf

Stamp duty: A 16,00 Euro duty stamp on the application.


Payment method

  • Bank Transfer
    Institute: Banca d’Italia
    Current account heading: Ministero della salute - Direzione Generale della sanità animale e dei farmaci veterinari
    IBAN: IBAN: IT88Q 01000 03245 3480 20258211 – Bank Identifier Code (BIC): BITAITRRENT - In the case of a payment from abroad the BIC code must be specified
    Reason for payment: the name of the veterinary medicinal product, the MA number and the European number of the variation must be specified
  • Bollettino Postale
    Causale: the name of the veterinary medicinal product, the MA number and the European number of the variation must be specified

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

  • Certified email

Outcome PublicationOutcome Publication

  • Institutional Site

Relevant lawRelevant law

  • 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;
  • Note 31/05/2021 (Prot 13402) Rules for managing Marketing Authorizations, Extensions and Variations to the terms of an authorization for medicinal products for veterinary use under the national procedure – updating of on-going procedures.

Consulta il Trovanormesalute

Contact usContact us

  • Referent Name: Anna Soriero
    Address: Viale G. Ribotta 5, 00144 Roma
    Telephone: 0659943601
    Email: a.soriero@sanita.it
  • Referent Name: Annalisa Montinaro
    Address: Viale G. Ribotta 5, 00144 Roma
    Telephone: 0659942328
    Email: a.montinaro@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