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Marketing authorization for veterinary medicinal products granted via the national procedure


Italiano|English

La proceduraProcedure

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

Chi può richiederloWho can apply?

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

Cosa serve per richiederloWhat 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.

ModuliApplication form and guidelines

Come si presenta la richiestaHow can I apply?

Quanto tempo ci vuoleHow long does it take?

 225 days

Quanto costaHow much does it cost?

Fee: https://www.salute.gov.it/imgs/C_17_pagineAree_527_1_file.pdf


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.

Come viene comunicato l'esitoHow do I know the outcome?

  • Certified email

Dove viene pubblicato l'esitoOutcome Publication

  • Institutional Site

NormativaRelevant law

Go to Trovanormesalute

ContattiContact us

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

Ufficio responsabile del procedimentoReferent Office for Legal proceedings

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

FAQQ&A

not present

App Online

TemiThematic site

Ufficio responsabile del procedimentoOffice


Data ultimo aggiornamento: 23 febbraio 2022


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