Home / Moduli e servizi online / Autorizzazione immissione in commercio medicinali veterinari / Authorization of variations requiring assessment to the terms of a MA for a veterinary medicinal product already granted via the mutual recognition procedure or the decentralized procedure

Authorization of variations requiring assessment to the terms of a MA for a veterinary medicinal product already granted via the mutual recognition procedure or the decentralized procedure


Italiano|English

La proceduraProcedure

Variations requiring assessment to the terms of the marketing authorization for a veterinary medicinal product granted via the mutual recognition procedure are authorized upon single application submitted in all the Member States interested in the procedure, accompanied by all the administrative information and the technical and scientific documentation required by current legislation.

Chi può richiederloWho can apply?

Marketing authorization holders of veterinary medicinal products, their legal representatives or delegated persons or companies.

Cosa serve per richiederloWhat do I need?

Variation application:

1) eApplication form completed in the relevant parts;

2) proof of the payment of the fee;

3) technical documentation supporting the application.

ModuliApplication form and guidelines

Come si presenta la richiestaHow can I apply?

Quanto tempo ci vuoleHow long does it take?

30-60-90 days

Quanto costaHow much does it cost?

Fee: Tariffe immissione in commercio medicinali veterinari

Stamp duty: 1 marca da € 16,00 sulla domanda/cover letter


Payment method

  • Bank Transfer
    Institute: Banca d’Italia
    Current account heading: Direzione Generale della sanità animale e dei farmaci veterinari
    IBAN: IBAN: IT88Q 01000 03245 3480 20258211 – Bank Identifier Code -BITAITRRENT- In the case of a payment from abroad, the BIC code must be specified.
    Reason for payment: the name of the veterinary medicinal product, the MA number and the European number of the variation must be specified

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

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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