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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

Who can apply?Who can apply?

Interested parties, their legal representatives or delegated persons or companies in the European Community.

What do I need?What do I need?

  • 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 guidelinesApplication form and guidelines

How can I apply?How can I apply?

How long does it take?How long does it take?

 225 days

How much does it cost?How much does it cost?


Payment method

  • Bank Transfer
    Institute: Banca d'Italia
    Current account heading: Ministero della Salute Direzione Generale della sanità animale e dei farmaci veterinari
    IBAN: IT88Q 01000 03245 3480 20258211 – Bank Identifier Code (BIC): BITAITRRENT -In the case of a payment from abroad, the BIC code must be specified.
    Reason for payment: marketing authorization for a veterinary medicinal product, MA variation or extension.
    Further instructions: The name of the veterinary medicinal product must be specified in the reason for payment.

How do I know the outcome?How do I know the outcome?

  • Certified email

Outcome PublicationOutcome Publication

  • Institutional Site

Relevant lawRelevant law

  • 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

Contact usContact us

  • Referent Name: Anna Soriero
    Address: Viale G.Ribotta 5,00144 Roma
    Telephone: 0659943601
  • Referent Name: Annalisa Montinaro
    Address: Viale G.Ribotta 5,00144 Roma
    Telephone: 0659942328

Referent Office for Legal proceedingsReferent Office for Legal proceedings

Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
Ufficio 4 - Medicinali veterinari

TemiThematic Site

Referent Office for Legal proceedingsOffice