Authorization of variations requiring assessment (VRA) to the terms of a MA for a veterinary medicinal product already granted via the national procedure

Variations requiring assessment (VRA) to the terms of the marketing authorization for a veterinary medicinal product granted via the national procedure are authorized upon application accompanied by all the administrative information and the technical and scientific documentation required by current legislation.

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

Variation application accompanied by:

• proof of the payment of the fee and the "marca da bollo" (duty special stamp) of € 16,00
• eApplication form completed in the relevant parts.

30-60-90 days according to the type, subject to a possible suspension of time limit.

• 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".