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Last modified date: 23 February 2022
Marketing authorization for veterinary medicinal products granted via the national procedure
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:
- PART 1 including:
- administrative data (applications, authorizations and fees);
- package leaflets (summary of product characteristics, package leaflet, labels);
- expert reports (critical reports made by a qualified expert, one for each of the three parts constituting the technical documentation of the veterinary medicinal product).
- PART 2 (Quality) including:
- pharmaceutical technique documentation relating to the quality characteristics of the veterinary medicinal product (qualitative and quantitative composition, description of the preparation method and controls on raw materials, checks during manufacture and on the finished product, stability testing, measures to prevent transmission of TSE …).
- PART 3 A – 3 B (Safety and Residues) including:
- documentation relating to the safety characteristics of the veterinary medicinal product (basic pharmacology, toxicological studies for single and repeated administrations, reproductive toxicity, teratogenesis, mutagenesis, residual studies for the definition of the waiting time for food-producing animals, data on environmental impact…).
- PART 4 (Efficacy) including:
- documentation relating to the pre-clinical and clinical characteristics of the veterinary medicinal product (basic pharmacology, pharmacodynamics, pharmacokinetics, tolerability in the target species, clinical tests carried out with the medicinal product in question on the requested target species and according to the planned dosage...).
The applicant may use one of the following registration dossiers:
- complete dossier;
- generic dossier or essentially similar product;
- bibliographic dossier;
- copy of product dossier or informed consent;
- “Hybrid” procedure;
- Applications for limited markets
- Applications in exceptional circumstances
Interested parties, their legal representatives or delegated persons or companies in the European Community.
- Application for marketing authorization with a 16,00 Euro duty stamp;
- eApplication form (in Italian or English) completed in the relevant parts;
- proof of the payment of the fee;
- documentation supporting the application (Parts 1, 2, 3 and 4) must be provided in Vnees format
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
- Application for a marketing authorisation
- EudraLex - Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use
- EudraLex - Volume 7 Scientific guidelines for medicinal products for veterinary use
- Volume 6B - Presentation and content of the dossier
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Online
App on line: Portale CESP
225 days
Rate: https://www.salute.gov.it/imgs/C_17_pagineAree_527_1_file.pdf
Payment method
- Through online payment via the integrated Online Payment connected with PagoPA
Causale: marketing authorization for a veterinary medicinal product, MA variation or extension.
- Certified email
- Institutional Site
- 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;
- Ministerial Decree of 5 November 2009. Amendments to Annex 1 to Legislative Decree No. 193/06;
- Ministerial Decree of 17 December 2007 on the placement of the barcode on packages of veterinary medicinal products;
- Ministerial Decree of 31 October 2007 transposing Directive 2006/130/EC, which implements Directive 2001/82/EC, as regards the establishment of criteria for exempting certain veterinary medicinal products intended for food-producing animals from the requirement of a veterinary prescription;
- Note 31/05/2021 (prot. 13402): Rules for managing Marketing Authorizations, Extensions and Variations to the terms of an authorization for medicinal products for veterinary use under the national procedure – updating of on-going procedures.
Consulta il Trovanormesalute
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Referent Name:
Anna Soriero
Address: Viale G.Ribotta 5,00144 Roma
Telephone: 0659943601
Email: a.soriero@sanita.it
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Referent Name:
Annalisa Montinaro
Address: Viale G.Ribotta 5,00144 Roma
Telephone: 0659942328
Email: a.montinaro@sanita.it
Referent Office for Legal proceedings
Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
Ufficio 4 - Medicinali veterinari
Thematic Site
Office