Reporting of cases of suspected adverse event for veterinary pharmacovigilance

Veterinary pharmacovigilance monitors the safety and efficacy of authorized veterinary medicinal products, constantly assessing their benefit/risk balance. To this end, the Ministry of Health, together with the Regional Pharmacovigilance Centers, promotes and makes available the means aimed at reporting any suspected adverse event, in particular:

a) any adverse (unfavorable and unintended) reaction in any animal to a veterinary medicinal product;

(b) any observation of a lack of efficacy of a veterinary medicinal product following its administration to an animal, whether or not in accordance with the summary of product characteristics;

c) any environmental incidents observed following the administration of a veterinary medicinal product to an animal;

d) any noxious reaction in humans exposed to a veterinary medicinal product;

e) any finding of a pharmacologically active substance or marker residue in a product of animal origin exceeding the maximum levels of residues established in accordance with Regulation (EC) No. 470/2009 after the set withdrawal period has been respected;

f) any suspected transmission of an infectious agent via a veterinary medicinal product;

g) any unfavorable and unintended reaction in an animal to a medicinal product for human use.

For reports, the doc, odt or online formats can be used (see modules section).

The Ministry of Health and/or the Regional Pharmacovigilance Centers submit a reply to the reporter at the email address (not CEM address) indicated in the reporting form.

Veterinarians and other professionals in the sector while carrying out their activities and anyone who has reason to suspect an adverse event resulting from the use of a veterinary medicinal product.

Suspected adverse event reporting form.

Thirty (30) minutes/one (1) hour.

Non è prevista la comunicazione dell'esito

• Legislative Decree No. 193/06, Chapter 7, Articles 91 to 99;
• Guidelines of 19 May 2008 relating to training on veterinary pharmacovigilance;
• 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.