The Ministry of Health publishes the list of generic veterinary medicinal products authorized for marketing on the national territory and the related reference veterinary medicinal products.
The list was presented in the presence of the Hon. Undersecretary Marcello Gemmato to complete the Infoday on veterinary medicines held last 4 and 5 December at the Biagio d’Alba auditorium of the Ministry of Health.
The objective was to:
create a list of generic veterinary medicines linked to the relevant reference veterinary medicine, with a view to facilitating all the actors involved in the prescription and dispensing of veterinary medicines, in the event of temporary shortages or questions with regulatory purposes, promoting a more economically fair market between generic veterinary medicinal products and reference veterinary medicinal products
To facilitate consultation, the table has been divided by active ingredient, name of the generic veterinary medicinal product, packaging (9-digit AIC), dosage and pharmaceutical form. The reference veterinary medicinal product is then reported, with the 9-digit AIC number. If the reference veterinary medicinal product is not marketed in Italy, the country in which it is authorized and the identification number in the UPD are indicated.
The list was prepared by experts from the Ministry, with the support of a pharmacist made available by Federfarma and involved consulting the dossiers of approximately 3000 veterinary medicines authorized in Italy. In addition to the active ingredient, the target species were evaluated, as well as, in the case of animals intended for food production, the withdrawal time.
This approach has the aim of allowing not only the replacement of the reference veterinary medicinal product with the relevant generic veterinary medicinal product, but also with other generic veterinary medicinal products. The list also includes some veterinary medicinal products authorized with a hybrid dossier, if the reference can be used for the purpose of substitution.
The fact that a reference medicinal product may have been withdrawn, not for health reasons, does not exclude the possibility of identifying the relevant generic veterinary medicinal products, also for the purposes of replacement. The list is now published for consultation by Marketing Authorization (AIC) holders who will be able to send any comments relating to errors or requests for additions by January 31, 2024.
Requests for modifications must be sent to the certified email address: [email protected] specifying in the subject:
“Comments on the Generic List” name of the veterinary medicinal product concerned and MA number
Once consolidated, the list will be published on a dedicated page of the portal and will be updated on a predefined basis so that it can always be complete with the addition of new authorized veterinary medicines.
Check the list: