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Last modified date: 19 September 2022

Authorization for parallel trade in veterinary medicinal products


ProcedureProcedure

Any wholesale distributor intending to market a veterinary medicinal product, already authorized in Italy and imported from an EU Member State where it has been authorized, may submit the application. The parallel import authorization (AIP) is issued by decree.

The parallel import authorization applies to veterinary medicinal products authorized via the mutual recognition procedure (MRP), the decentralized procedure (DCP), the subsequent recognition procedure (SRP) or the national procedure (NP).


Who can apply?Who can apply?

Wholsale distributors established in the European Union.


What do I need?What do I need?

 


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-IMP-AIP
    Further instructions: Available only of sent from another certified emai. The original electronic documents must be submitted preferably in pdf format and the images contained must not exceed the graphic resolution of 150 dpi. The same rule applies to scanned original paper documents.
  • Online
    App on line: Portal CESP

How long does it take?How long does it take?

30 giorni


How much does it cost?How much does it cost?

Rate: Tariffe immissione in commercio medicinali veterinari


Payment method

  • Through online payment via the integrated Online Payment connected with PagoPA
    Causale: Authorization for parallel import of veterinary medicinal product (the name of the veterinary medicinal product must be specified)

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 relating to veterinary medicinal products and repealing Directive 2001/82/EC;
  • Ministerial Decree of 5 August 2010 – “Authorization procedures for the parallel import of veterinary medicinal products”;
  • Legislative Decree No. 193 of 6 April 2006 as amended – “Implementation of Directive 2004/28/EC laying down the Community code relating to veterinary medicinal products”;
  • Ministerial Decree of 17 December 2007 – “How to use the bar code on the packages of veterinary medicinal products placed on the market”.

Consulta il Trovanormesalute

Contact usContact us

  • Referent Name: Rita Quondam Giandomenico
    Address: Viale G. Ribotta 5 - 00144 Roma
    Telephone: 06 5994 6255
    Email: r.quondam@sanita.it
  • Referent Name: Fabrizio Marchion
    Address: Viale G. Ribotta 5 - 00144 Roma
    Telephone: 06 5994 3185
    Email: f.marchion-esterno@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



TemiThematic Site


Referent Office for Legal proceedingsOffice