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Reporting of cases of suspected adverse event for veterinary pharmacovigilance


Italiano|English

La proceduraLa procedura

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.

 

Chi può richiederloChi può richiederlo

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.

 

 

Cosa serve per richiederloCosa serve per richiederlo

 

Suspected adverse event reporting form.

ModuliModuli

Come si presenta la richiestaCome si presenta la richiesta

  • PEC
    Indirizzo di PEC: dgsa@postacert.sanita.it
    Oggetto: MDV-FMV-PSK - Suspected adverse event reporting form
    Istruzioni aggiuntive: Only for forms in online format. The downloaded file must be saved and sent as an attachment as it is, without being modified and scanned.
  • E-Mail
    Indirizzo email destinatario: farmacovigilanzavet@sanita.it
    Oggetto: MDV-FMV-PSK - Suspected adverse event reporting form
    Istruzioni aggiuntive: Only for forms in doc format and odt format. The documents sent by traditional email must be signed digitally.

Quanto tempo ci vuoleQuanto tempo ci vuole

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

 

Quanto costaQuanto costa

Non è previsto il pagamento di alcuna tariffa

Come viene comunicato l'esitoCome viene comunicato l'esito

Non è prevista la comunicazione dell'esito

Dove viene pubblicato l'esitoDove viene pubblicato l'esito

Non è prevista la pubblicazione dell'esito

NormativaNormativa

  • 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.


Consulta il Trovanormesalute

ContattiContatti

Ufficio responsabile del procedimentoUfficio responsabile del procedimento

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

FAQFAQ

Non sono presenti FAQ

TemiAree e siti tematici

Ufficio responsabile del procedimentoUfficio


Data ultimo aggiornamento: 29 marzo 2022


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