Services on line

Procedure

Variations requiring assessment (VRA) to the terms of the marketing authorization for a veterinary medicinal product granted via the national procedure are authorized upon application 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 accompanied by:

• proof of the payment of the fee and the "marca da bollo" (duty special stamp) of € 16,00
• eApplication form completed in the relevant parts.

Application form and guidelines

• Corrigendum to Commission Notice - Guidance to Applicants - Veterinary Medicinal Products (Official Journal of the European Union C, C/2024/1443, 14 February 2024)
• eApplication form

How can I apply?

• Online
  App on line: Portale CESP
  

How long does it take?

30-60-90 days according to the type, subject to a possible suspension of time limit.

How much does it cost?

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

Stamp duty: A 16,00 Euro duty stamp

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

• 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;
• Legislative Decree n. 218, 7 December 2023 "Adaptation of national legislation to the provisions of 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, pursuant article 17 of  law 4 agosto 2022, n. 127".

Consulta il Trovanormesalute

Contact us

• Referent Name: Anna Soriero
  Address: Viale G. Ribotta 5, 00144 Roma
  Telephone: 0659943601
  Email: a.soriero@sanita.it
  
• Referent Name: Annalisa Montinaro
  Address: Viale G. Ribotta 5, 00144 Roma
  Telephone: 0659942328
  Email: a.montinaro@sanita.it
  

Referent Office for Legal proceedings

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

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Thematic Site

• Medicinali e dispositivi veterinari

Office

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