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.
Marketing authorization holders of veterinary medicinal products, their legal representatives or delegated persons or companies.
Variation application accompanied by:
Application form and guidelines
30-60-90 days according to the type, subject to a possible suspension of time limit.
Rate: https://www.salute.gov.it/imgs/C_17_pagineAree_527_1_file.pdf
Stamp duty: A 16,00 Euro duty stamp
Payment method
Consulta il Trovanormesalute
Referent Office for Legal proceedings
Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
Ufficio 4 - Medicinali veterinari
Not present
App Online
Thematic Site
Office
Last modified date: 11 March 2024