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Authorization for the conduct of clinical trials of veterinary medicinal products in animals and any modification thereof


La proceduraProcedure

With a view to obtaining the authorization for the conduct of clinical trials of veterinary medicinal products in animals, an application must be submitted to the Ministry of Health.

If the trial application concerns immunological veterinary medicinal products or veterinary medicinal products compulsorily authorized via the centralized procedure, the application must also be submitted to the National Health Institute to obtain its technical advice.

The authorization is not necessary if the trial is aimed at verifying the safety and efficacy of veterinary medicinal products, for which a marketing authorization has been granted in Italy and in the other Member States, without modifying the relevant provisions with the granting of such authorization.


Chi può richiederloWho can apply?

Whoever intends to conduct clinical trials of veterinary medicinal products in animals.

Cosa serve per richiederloWhat do I need?

The application accompanied by the following documents:

  • a copy of the notice sent to the Health Department of the Region interested in the trial sixty days before the beginning of the trial and to the competent Local Health Unit or, in the case of a  multicenter study, to all competent Local Health Units and Regions;
  • an experimental protocol compliant with current legislation, dated and signed by the person responsible for the trial and the sponsor requesting the trial;
  • a public declaration of conflict of interest by the person responsible for the trial, drawn up in accordance with the relevant model;   
  • a detailed experimental project including, for all animal species, at least the following information:

a) the name and curriculum vitae of the person responsible for the trial;

b) the name of the sponsor and the monitor;

c) the indicative duration of trial;

d) a description of the animals concerned: number of animals involved in the trial, species, breed, attitude, age, physiological status, identification of the animals in accordance with current legislation, where applicable, farming method and management, number of animals treated and number of animals in the control group;

e) a description of the veterinary medicinal product to be used: data relating to the environmental impact and quality requirements in accordance with current Community legislation, statement on the safety of the product as observed following pre-clinical tests, relevant pharmacovigilance information, possible first draft of summary of product characteristics;

f) the place where the trial is to be conducted: site(s), any company code required by current legislation, role of the competent Local Health Unit(s) and Region(s), feed mills possibly involved and their role;

g) treatment methods: number of planned treatments, dosage and quantity of veterinary medicinal products to be used;

h) the informed consent of the owner(s) of the animals to conduct the trial;

i) only for animals intended for human consumption: substantiated indication of the proposed waiting time, laboratory responsible for determining the residues, destination of the animals subject to trial (destruction or slaughter) and of their products and by-products;

j) the receipt of payment.

- At the end of the trial, the sponsor is required to provide the Ministry of Health and the National Health Institute, if involved, with a final report.

ModuliApplication form and guidelines

Come si presenta la richiestaHow can I apply?

  • Certified email (PEC)
    Certified email: dgsa@postacert.sanita.it
    Email subject: MDV-SCV-RA - Sperimentazione medicinale veterinario
    Further instructions: Additional instructions: also the name of the trial product and the applicant must be specified in the subject – this is only accepted if sent from another CEM.

Quanto tempo ci vuoleHow long does it take?

55 days

Quanto costaHow much does it cost?

Fee: 840 Euro per application to the Ministry including authorization concerns veterinary medicinal products for which a technical advice by the National Health Institute is required

Payment method

  • Through online payment via the integrated Online Payment connected with PagoPA
    Causale: Trial of veterinary medicinal product

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

  • Certified email

Dove viene pubblicato l'esitoOutcome Publication

not present

NormativaRelevant law

Go to Trovanormesalute

ContattiContact us

  • Referent Name: Rita Quondam Giandomenico
    Address: Viale G. Ribotta 5, 00144 Roma
    Telephone: 0659946255
    Email: r.quondam@sanita.it

Ufficio responsabile del procedimentoReferent Office for Legal proceedings

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


not present

TemiThematic site

Ufficio responsabile del procedimentoOffice

Data ultimo aggiornamento: 31 agosto 2023