Medicinali e dispositivi veterinari

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Procedure

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

Who can apply?

 

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

What 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.

Application form and guidelines

• EudraLex - Volume 6 Notice to Applicants and Regulatory Guidelines for Medicinal products for Veterinary use
• EudraLex - Volume 7 Scientific guidelines for medicinal products for veterinary use
• Volume 6B - Presentation and content of the dossier

How 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

How long does it take?

MRP: 90 days

DCP: 225 days

How 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

• Through online payment via the integrated Online Payment connected with PagoPA
  Causale: Reason for payment: the name of the veterinary medicinal product and the European procedure number must be specified.

How do I know the outcome?

• Certified email

Outcome Publication

• Official Gazette

Relevant law

Go to Trovanormesalute

Contact us

• Referent Name: Stefania Dalfrà
  Address: Via G. Ribotta, 5 00144 Roma
  Telephone: 06.59946248
  Email: s.dalfra@sanita.it
  
• Referent Name: Loredana Ragni
  Address: Via G. Ribotta, 5 00144 Roma
  Telephone: 06.59943741
  Email: l.ragni@sanita.it
  

Referent Office for Legal proceedings

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

Q&A

not present

App Online

• Portale CESP

Thematic site

• Recognition of health professions qualifications

Office

• Direzione Generale della Sanità Animale e dei Farmaci veterinari (DGSAF)

Data ultimo aggiornamento: 16 febbraio 2022