The marketing authorization (MA) for veterinary medicinal products is granted via the mutual recognition procedure and the decentralized procedure at the request of the interested party, following the assessment of the documentation on the pharmaceutical technique, safety, residues and clinical efficacy. Such procedure allows to obtain a marketing authorization in several Member States simultaneously, submitting the same dossier in all the countries concerned.
In the case of a mutual recognition procedure, the veterinary medicinal product has already been authorized in one Member State, which will act as the reference State to extend the authorization to other Member States.
In the case of a decentralized procedure, the application for a marketing authorization can be submitted simultaneously in several Member States.
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 EU or EEA.
Application form and guidelines
MRP: 90 days
DCP: 225 days
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/cover letter.
Payment method
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;
Legislative Decree No. 193 of 6 April 2006 implementing Directive 2004/28/EC (as amended) on the Community code relating to veterinary medicinal products”, Articles 12, 13, 14, 15, 16, 17, 18, 19; Chapter IV (Articles 36 to 45); Article 110;
Decree of the Ministry of Labour, Health and Social Politics of 5 November 2009, Annex 1;
Consulta il Trovanormesalute
Referent Office for Legal proceedings
Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
Ufficio 4 - Medicinali veterinari
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Last modified date: 16 February 2022