Similar and Generic Veterinary Medicines
On October 17, 2012, Law No. 12.689/2012 entered into force, that establishes the possibility of introducing these kind of medicines after the expiration of the patent which
protects the reference product and taking into consideration the existence of exclusive rights to use the clinical trials and related dossiers provided by Brazilian Law 10.603/2002.
Similar veterinary medicines must bear the owner’s trade name or the trademark and should contain the same active principle, pharmaceutical concentration and form as the reference medicine.
Generic veterinary medicines must be designated by the Brazilian Common Denomination (DCB) or by the International Nonproprietary Name (DCI). They must contain the same active ingredient, concentration and form, administration, dosage and therapeutic indication as the reference medicine. Bioequivalence to the reference medicine, its efficacy and safety must be demonstrated by means of pharmaceutical studies with the Ministry of Agriculture, Livestock and Supply – MAPA.
MAPA will shortly regulate the simplified proceeding of registration of the generic veterinary medicines.
Sources: Di Blasi, Parente & Associados