Variations requiring assessment to the terms of the marketing authorization for a veterinary medicinal product granted via the mutual recognition procedure are authorized upon single application submitted in all the Member States interested in the procedure, 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:
1) eApplication form completed in the relevant parts;
2) proof of the payment of the fee;
3) technical documentation supporting the application.
Application form and guidelines
30-60-90 days
Fee: Tariffe immissione in commercio medicinali veterinari
Stamp duty: 1 marca da € 16,00 sulla domanda/cover letter
Payment method
Go to 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
Data ultimo aggiornamento: 07 dicembre 2022
