Marketing authorization for veterinary medicinal products granted via the national procedure

The marketing authorization for veterinary medicinal products is granted at the request of the interested party, following the assessment of the documentation on the pharmaceutical technique, safety, residues and clinical efficacy carried out by the Ministry of Health with the scientific support of the Advisory Committee for Veterinary Medicinal Products. The MA is granted by decree and has unlimited validity.

The registration dossier of a veterinary medicinal product consists of 4 parts, divided as follows:

• PART 1 including:
  • administrative data (applications, authorizations and fees);
  • package leaflets (summary of product characteristics, package leaflet, labels); 
  • expert reports (critical reports made by a qualified expert, one for each of the three parts constituting the technical documentation of the veterinary medicinal product).

• PART 2 (Quality) including:
  • pharmaceutical technique documentation relating to the quality characteristics of the veterinary medicinal product (qualitative and quantitative composition, description of the preparation method and controls on raw materials, checks during manufacture and on the finished product, stability testing, measures to prevent transmission of TSE …).

• PART 3 A – 3 B (Safety and Residues) including:
  • documentation relating to the safety characteristics of the veterinary medicinal product (basic pharmacology, toxicological studies for single and repeated administrations, reproductive toxicity, teratogenesis, mutagenesis, residual studies for the definition of the waiting time for food-producing animals, data on environmental impact…).

• PART 4 (Efficacy) including:
  • documentation relating to the pre-clinical and clinical characteristics of the veterinary medicinal product (basic pharmacology, pharmacodynamics, pharmacokinetics, tolerability in the target species, clinical tests carried out with the medicinal product in question on the requested target species and according to the planned dosage...).

Interested parties, their legal representatives or delegated persons or companies in the European Community.

• Application for marketing authorization
• eApplication form (in Italian or English) completed in the relevant parts;
• proof of the payment of the fee and a 16,00 Euro duty stamp ("marca da bollo");  
• documentation supporting the application (Parts 1, 2, 3 and 4) must be provided in Vnees format

When submitting the application via CESP, the applicant must send a notification email to the contact persons indicated below, specifying the name of the product, the AIC number and the type of request.

 210 days 210 days after submission of a valid application.

• 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 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 on the placement of the barcode on packages of veterinary medicinal products;