Medicinali e dispositivi veterinari

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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 (file format doc, file format 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

How do I know the outcome?

• Certified email

Outcome Publication

not present

Relevant law

Go to 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

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: 15 febbraio 2022