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

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.

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

Request by template.

30 giorni

• 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 7 December, no.218 "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"
• 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”.