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Request for access to documents concerning the marketing authorization (MA) for veterinary medicinal products


Italiano|English
Versione stampabile Printable version

La proceduraProcedure

Chi può richiederloWho can apply?

Cosa serve per richiederloWhat do I need?

ModuliApplication form and guidelines

Come si presenta la richiestaHow can I apply?

Quanto tempo ci vuoleHow long does it take?

Quanto costaHow much does it cost?

Come viene comunicato l'esitoHow do I know the outcome?

Dove viene pubblicato l'esitoOutcome Publication

NormativaRelevant law

ContattiContact us

Ufficio responsabile del procedimentoReferent Office for Legal proceedings

FAQQ&A

ProcedureProcedure

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?Who can apply?

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

What do I need?What do I need?

Request by template.

Application form and guidelinesApplication form and guidelines

How can I apply?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?How long does it take?

30 giorni

How much does it cost?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?How do I know the outcome?

  • Certified email

Outcome PublicationOutcome Publication

not present


Relevant lawRelevant 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 usContact 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 proceedingsReferent Office for Legal proceedings

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

FAQFAQ

Not present

App Online

Thematic SiteThematic Site

OfficeOffice


Last modified date: 15 February 2022


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