The Ordinance constitutes a regulatory milestone by governing generic-type products for veterinary use, filing a long-standing gap in this sector. The text establishes formal distinctions between three categories of veterinary drugs: reference, generic, and interchangeable similar drugs.

Additionally, the draft protects innovation and values the scientific and technological efforts of companies that develop reference medicines. It provides that incremental innovations made to a reference drug may only be incorporated into generic or interchangeable similar drugs registered based thereon after the expiration of the protection period for the regulatory data submitted as a requirement for approving the commercialization of products, 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, analyze, and answer 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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