July 9, 2012
- Kasznar Leonardos
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.
Last related news
September 6, 2022
Brazilian National Health Surveillance Agency authorizes exceptional drug and vaccine use against Monkeypox by the Ministry of Health
The Ministry of Health (MH) sent Brazilian National Health Surveillance Agency (Anvisa) a request for exemption from the sanitary registration, on an … Brazilian National Health Surveillance Agency authorizes exceptional drug and vaccine use against Monkeypox by the Ministry of Health
August 16, 2022
Brazilian National Health Surveillance Agency (ANVISA) decides to ban Carbendazim
On August 8th, 2022, during the 12th Extraordinary Public Meeting of DICOL, ANVISA’s Collegiate Board of Directors announced the completion of the toxicological … Brazilian National Health Surveillance Agency (ANVISA) decides to ban Carbendazim
July 19, 2022
Carbendazim toxicological revaluation about to be completed by ANVISA
In December 2019, ANVISA started the process of toxicological revaluation of the Active Ingredient (AI) Carbendazim, as signs of toxicity were identified … Carbendazim toxicological revaluation about to be completed by ANVISA