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Procedure

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.

Who can apply?

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

What 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.

Application form and guidelines

• Application form
• 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

How can I apply?

• On line
  App on line: Portale CESP
  

How long does it take?

30-60-90 days

How much does it cost?

Rate: Tariffe immissione in commercio medicinali veterinari

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

Payment method

• Through online payment via the integrated Online Payment connected with PagoPA
  Causale: the name of the veterinary medicinal product, the MA number and the European number of the variation must be specified

How do I know the outcome?

• Certified email

Outcome Publication

• Institutional Site

Relevant law

• Regolamento (UE) 2019/6 del Parlamento Europeo e del Consiglio dell'11 dicembre 2018 relativo ai medicinali veterinari e che abroga la direttiva 2001/82/CE;
• Legislative Decree No. 193/06 as amended;
• Decree of the Ministry of Labour, Health and Social Politics of 5 November 2009, Annex 1.

Consulta il Trovanormesalute

Contact us

• Referent Name: Lauro Cascia
  Telephone: 39 06 59943913
  Email: l.cascia@sanita.it
  
• Referent Name: Gianluca Antonio Romeo
  Telephone: 39 06 59943564
  Email: ga.romeo-esterno@sanita.it
  

Referent Office for Legal proceedings

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

FAQ

Not present

App Online

• Portale CESP

Thematic Site

• Medicinali e dispositivi veterinari

Office

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

Last modified date: 07 December 2022