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Procedure

Those interested in requesting information on the marketing authorization (MA) for veterinary medicinal products must fill in the relevant template, specifying the information subjected to access, namely the summary of product characteristics (SPC) and/or the MA assessment report. Through such request, it is possible to consult the documents or take copies.

Who can apply?

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

What do I need?

Request by template.

Application form and guidelines

• Richiesta di accesso ai documenti amministrativi (formato doc, formato odt)

How can I apply?

• Certified Email (PEC)
  Certified email: dgsa@postacert.sanita.it
  Email subject: MDV-AIC-AA
  Further instructions: Questa modalità è consentita solo se inviata da altra PEC
  
• On line
  App on line: Portale CESP
  

How long does it take?

30 giorni

How much does it cost?

Stamp duty: Euro 0,50 da una a due copie estratte; Euro 1,00 da tre a quattro copie e cosi' di seguito

Payment method

• Through online payment via the integrated Online Payment connected with PagoPA
  

How do I know the outcome?

• Certified email

Outcome Publication

not present

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 No. 193 of 6 April 2006 implementing Directive 2004/28/EC (as amended) on the Community code relating to veterinary medicinal products;
• Law No. 241 of 1990 containing new rules regarding administrative procedure and the right of access to administrative documents, as amended;
• Presidential Decree No. 184 of 12 April 2006 “Regulation laying down the rules on access to legislative documents”.

 

Consulta il Trovanormesalute

Contact us

• Referent Name: Fabrizio Marchion
  Address: Viale G.Ribotta, 5 -00144
  Telephone: 0659943185
  Email: f.marchion-esterno@sanita.it
  
• Referent Name: Angelica Maggio
  Address: Viale G.Ribotta, 5 -00144
  Telephone: 0659946173
  Email: a.maggio@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: 15 February 2022