The marketing authorization for veterinary medicinal products is granted at the request of the interested party, following the assessment of the documentation on the pharmaceutical technique, safety, residues and clinical efficacy carried out by the Ministry of Health with the scientific support of the Advisory Committee for Veterinary Medicinal Products. The MA is granted by decree and has unlimited validity.
The registration dossier of a veterinary medicinal product consists of 4 parts, divided as follows:
The applicant may use one of the following registration dossiers:
Interested parties, their legal representatives or delegated persons or companies in the European Community.
When submitting the application via CESP, the applicant must send a notification email to the contact persons indicated below, specifying the name of the product, the AIC number and the type of request.
Application form and guidelines
225 days
Fee: https://www.salute.gov.it/imgs/C_17_pagineAree_527_1_file.pdf
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: 23 febbraio 2022