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).
Wholsale distributors established in the European Union.
- 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.
MDV-IMP-AIP
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.
30 giorni
Authorization for parallel import of veterinary medicinal product (the name of the veterinary medicinal product must be specified)
- 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;
Legislative Decree n. 218, 7 December 2023 "Adaptation of national legislation to the provisions of 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, pursuant article 17 of law 4 agosto 2022, n. 127".
- 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