Authorization of variations requiring assessment to the terms of a MA for a veterinary medicinal product already granted via the mutual recognition procedure or the decentralized procedure

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.

30-60-90 days

• Regolamento (UE) 2019/6 del Parlamento Europeo e del Consiglio dell'11 dicembre 2018 relativo ai medicinali veterinari e che abroga la direttiva 2001/82/CE;
• Legislative Decree No. 193/06 as amended;
• Decree of the Ministry of Labour, Health and Social Politics of 5 November 2009, Annex 1.