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.
Whoever intends to conduct clinical trials of veterinary medicinal products in animals.
The application accompanied by the following documents:
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.
Application form and guidelines
55 days
Rate: 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
not present
Consulta il Trovanormesalute
Referent Office for Legal proceedings
Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)
Ufficio 4 - Medicinali veterinari
Not present
Thematic Site
Office
Last modified date: 31 August 2023
