The Impact of the Registration of Veterinary Medicines on Agricultural Production

The 2017 MAPA Ordinance reduced the deadline for registering veterinary medicines with “incremental innovations”, such as new formulas, concentrations or therapeutic indications, to six months. This measure prioritizes products that bring benefits to public and animal health, such as antiparasitic and antimicrobial drugs, sectors that account for 50% of livestock revenues. Digitizing the process via the SIPEAGRO System also optimizes processing, allowing 100% online applications for registered companies.

Impact on livestock farming:

• Cost reduction: Producers gain access to modern medicines at competitive prices, especially generics in markets with few options 1.
• Continuous innovation: Laboratories are encouraged to develop solutions for diseases with no available treatments, strengthening herd resilience.

Brazilian regulations are in line with the One Health concept, which integrates human, animal and environmental health. Strict control of residues in veterinary products is critical for exports, since Brazil accounts for 24% of beef protein and 33% of poultry globally. Decree 5.053/2004, which is currently being revised, establishes inspection standards to prevent contamination that compromises the food chain.

Impact on agriculture:

• International compliance: Importing countries require safety certifications, such as the traceability of antimicrobials.
• Prevention of sanitary barriers: Residues above the limit can result in embargoes, affecting US$8 billion in annual meat exports.

Companies that invest in regulatory compliance not only avoid health risks, but also capitalize on opportunities in a sector that is expanding by 10% a year.

The revision of the regulatory framework, including the future replacement of IN 11/2015, aims to harmonize standards of good practice and quality, meeting the demands of entities such as Anvisa and the OIE (World Organization for Animal Health). Prioritizing registrations for species with no therapeutic alternatives will also boost production diversification, such as in pig farming and aquaculture.

Impact on agriculture:

• Access to new markets: Clear rules facilitate entry into EU and Asian countries, which require proof of efficacy and safety.
• Fostering the PET sector: With 25% of veterinary sales, the regulation of supplements and animal hygiene expands opportunities in urban niches.

The registration of veterinary medicines is a growth vector for agriculture, balancing innovation, safety and competitiveness.

In this complex scenario, Stone Okamont stands out as an essential ally for companies seeking to register veterinary medicines with the MAPA. With expertise in:

• Documentation management
• Legislative monitoring
• Intermediation with MAPA

Stone Okamont positions itself as a strategic partner, transforming bureaucratic challenges into competitive advantages. For agribusiness leaders, having specialized support is not just a smart choice - it's an indispensable differentiator in an increasingly demanding and globalized market.