Answer given by Ms Kyriakides on behalf of the European Commission
12.4.2021
Article 10(1)(b)(i) of Directive 2001/82/EC on the Community Code relating to veterinary medicinal products[1] provides, by way of exception, that a medicinal product authorised for human use may be used to treat a non-food-producing animal, if there is no authorised veterinary medicinal product available to treat the condition.
From 28 January 2022, Regulation (EU) 2019/6 on veterinary medicinal products[2] will enter into application and replace Directive 2001/82/EC. Article 112(1)(b) of Regulation (EU) 2019/6 contains a similar provision to the directive.
It states that where there is no authorised veterinary medicinal product available for an indication concerning a non-food-producing animal, the veterinarian may exceptionally treat the animal concerned with a medicinal product authorised for human use.
In both of the above cases, the only justification that allows a veterinarian prescribing a medicinal product authorised for human use is the lack of availability of a suitable veterinary medicinal product. Therefore, the cost of a veterinary medicinal product would not be an acceptable justification.
The Commission was not aware of Law No 178 of 30 December 2020 referred to by the Honourable Member and intends to clarify the matter further with the Italian competent authorities.