This Tuesday, April 14, 2026, the Brazilian Ministry of Agriculture and Livestock (“MAPA”) published Ordinance SDA/MAPA #1,590, dated April 13, 2026, in the Federal Register, opening a 45-day consultation on the draft Ordinance establishing the Technical Regulations for the registration of generic and interchangeable similar veterinary drugs.

The Ordinance constitutes a regulatory milestone by establishing rules for generic products for veterinary use, thereby filing a long-standing regulatory gap in the sector. The text sets forth formal distinctions among three categories of veterinary drugs: reference drugs, generic drugs, and interchangeable similar drugs.

Additionally, the draft protects innovation and recognizes the scientific and technological efforts of companies that develop reference drugs. It provides that incremental innovations to a reference drug may only be incorporated into generic or interchangeable similar drugs registered based on it after the expiration of the protection period for the regulatory data submitted as a requirement for market approval, pursuant to Statute #10,603/2002.

Interested parties have until May 29, 2026, to submit their technical contributions through the Regulatory Acts Monitoring System (SISMAN). After the 45-day period, MAPA will consolidate, review, and respond to the contributions received and is expected to publish the final and definitive version of the Ordinance.

The publication of Ordinance SDA/MAPA #1,590 in the Federal Register is available in Portuguese here.

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