Medicinali e dispositivi veterinari

Printable version

Procedure

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?

Wholsale distributors established in the European Union.

What do I need?

• AIP application (cover letter) with revenue stamp;
• proof of payment of the fee;
• information documentation prepared using the specific CMDv form: “Application for approval to carry out parallel trade of a veterinary medicinal product (VMP) ” and the relevant annexes.

 

Application form and guidelines

• Application for approval to carry out parallel trade of a veterinary medicinal product (VMP
• CMDv Best Practice Guide for parallel trade in veterinary medicinal products

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.
  
• On line
  App on line: Portal CESP
  

How long does it take?

30 giorni

How much does it cost?

Fee: 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?

• Certified email

Outcome Publication

not present

Relevant law

Go to Trovanormesalute

Contact 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 proceedings

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

Q&A

not present

App Online

• Portal CESP

Thematic site

• Recognition of health professions qualifications

Office

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

Data ultimo aggiornamento: 19 settembre 2022