Newsletter 2012.05 – Brazilian government enacts law creating generic veterinary medicinal products

On 20 July 2012, Law No. 12,689, of 19 July 2012, was published in the Federal Official Gazette. This law seeks to create generic veterinary medicinal products in the country and to establish rules concerning the marketing authorisation of such products to be applied by the Ministry of Agriculture, Animal Husbandry and Supply (MAPA).

In brief, two new categories of veterinary medicinal products have been created in addition to the existing reference veterinary drugs: similar (“branded generic”) and generic medicinal products for veterinary use.

According to Law No. 12,689/12, a similar veterinary medicinal product shall mean a medicinal product which has the same active substance, the same concentration and pharmaceutical form as the reference medicinal product for veterinary use, but which excipients may or not be identical, always being identified by its trade mark. Law No. 12,689/12 has apparently not considered a similar veterinary medicinal product to be interchangeable with the reference product, following the same terms of the legislation for drugs for human use.