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Marketing authorization (MA) for veterinary medicinal products granted via the mutual recognition procedure, the decentralized procedure and the subsequent recognition procedure


Italiano|English

La proceduraProcedure

The marketing authorization (MA) for veterinary medicinal products is granted via the mutual recognition procedure and the decentralized procedure at the request of the interested party, following the assessment of the documentation on the pharmaceutical technique, safety, residues and clinical efficacy. Such procedure allows to obtain a marketing authorization in several Member States simultaneously, submitting the same dossier in all the countries concerned.

In the case of a mutual recognition procedure, the veterinary medicinal product has already been authorized in one Member State, which will act as the reference State to extend the authorization to other Member States.

In the case of a decentralized procedure, the application for a marketing authorization can be submitted simultaneously in several Member States.   

The registration dossier of a veterinary medicinal product consists of 4 parts, divided as follows:

  • PART 1 including:
    • administrative data (applications, authorizations and fees);
    • package leaflets (summary of product characteristics, package leaflet, labels); 
    • expert reports (critical reports made by a qualified expert, one for each of the three parts constituting the technical documentation of the veterinary medicinal product).
       
  • PART 2 (Quality) including:
    • pharmaceutical technique documentation relating to the quality characteristics of the veterinary medicinal product (qualitative and quantitative composition, description of the preparation method and controls on raw materials, checks during manufacture and on the finished product, stability testing, measures to prevent transmission of TSE …).

 

  • PART 3A –3B (Safety and Residues) including:
    • documentation relating to the safety characteristics of the veterinary medicinal product (basic pharmacology, toxicological studies for single and repeated administrations, reproductive toxicity, teratogenesis, mutagenesis, residual studies for the definition of the waiting time for food-producing animals, data on environmental impact…).

 

  • PART 4 (Efficacy) including:
    • documentation relating to the pre-clinical and clinical characteristics of the veterinary medicinal product (basic pharmacology, pharmacodynamics, pharmacokinetics, tolerability in the target species, clinical tests carried out with the medicinal product in question on the requested target species and according to the planned dosage...).

 

The applicant may use one of the following registration dossiers:

  • Complete dossier;
  • Generic dossier or essentially similar product;
  • Bibliographic dossier;  
  • Copy of product dossier or informed consent;
  • “hybrid” procedure.
  • Applications for limited markets
  • Applications in exceptional circumstances

Chi può richiederloWho can apply?

 

Interested parties, their legal representatives or delegated persons or companies in the EU or EEA. 

Cosa serve per richiederloWhat do I need?

  • Cover Letter , eApplication form (in Italian or English) completed in the relevant parts;
  • proof of the payment of the fee;   
  • technical documentation supporting the application, as reported in Annex 2 of Regulation (EU) 2019/6.

ModuliApplication form and guidelines

Come si presenta la richiestaHow can I apply?

  • On line
    App on line: Portale CESP
  • Corriere Espresso
    Ufficio destinatario: Direzione Generale della sanità animale e dei farmaci veterinari - Uff.04 ex DGSA - Medicinali veterinari e dispositivi medici per uso veterinario.
    Indirizzo destinatario: Viale Giorgio Ribotta 5, 00144 ROMA

Quanto tempo ci vuoleHow long does it take?

MRP: 90 days

DCP: 225 days

Quanto costaHow much does it cost?

Fee: https://www.salute.gov.it/imgs/C_17_pagineAree_527_1_file.pdf

Stamp duty: A 16,00 Euro duty stamp on the application/cover letter.


Payment method

  • Bank Transfer
    Institute: Banca d’Italia
    Current account heading: Ministero della salute - Direzione Generale della sanità animale e dei farmaci veterinari
    IBAN: IT88Q 01000 03245 3480 20258211 – Bank Identifier Code (BIC): BITAITRRENT
    Reason for payment: Reason for payment: the name of the veterinary medicinal product and the European procedure number must be specified.

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

  • Certified email

Dove viene pubblicato l'esitoOutcome Publication

  • Official Gazette

NormativaRelevant law

Go to Trovanormesalute

ContattiContact us

  • Referent Name: Stefania Dalfrà
    Address: Via G. Ribotta, 5 00144 Roma
    Telephone: 06.59946248
    Email: [email protected]
  • Referent Name: Loredana Ragni
    Address: Via G. Ribotta, 5 00144 Roma
    Telephone: 06.59943741
    Email: [email protected]

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: 16 febbraio 2022


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