Import, Export, and Compliance (2023/2024)
Introduction to the Veterinary Products Market in Brazil (2023/2024)
The Veterinary Products Market in Brazil for 2023/2024 stands as a vital contributor to the country’s economic and agricultural landscape. With an annual market value of approximately R$5 billion and over 7,000 registered veterinary products, Brazil plays a critical role in animal health and welfare. Spanning products for livestock, pets, and wildlife, the market includes vaccines, diagnostics, antiparasitics, and more, emphasizing quality and regulatory standards under the Ministry of Agriculture, Livestock, and Food Supply (MAPA).
International companies eyeing Brazil’s dynamic market must navigate complex regulatory requirements. Hegemoni Regulatory & Business Solutions offers expertise in this sector, guiding businesses through compliance processes, including product registration, import/export procedures, and regulatory adherence.
Overview of the Veterinary Products Market in 2023/2024
Brazil’s veterinary products market has witnessed significant growth, driven by its large agricultural base and demand for quality animal health solutions. The market is dominated by products for cattle, making up 19% of all offerings for animal health, particularly in categories addressing infections and parasitic diseases. The demand for antiparasitic agents, antimicrobials, and vaccines is strong, underscoring the importance of regulatory compliance for imported veterinary products to maintain market standards.
Schedule a meeting with our regulatory experts to learn more about streamlining your product registration journey.
Veterinary Product Registration Requirements in Brazil
To legally sell veterinary products in Brazil, companies must adhere to the regulations enforced by MAPA. MAPA’s registration framework ensures that all biological, chemical, and technological products meet the stringent safety and efficacy standards set for both local and imported items.
MAPA’s registration includes two key phases:
- Company Licensing: Only companies with MAPA-approved licenses may begin the registration process for individual products.
- Product Registration: Each veterinary product, depending on its type, requires either registration or listing with MAPA, particularly for products intended for animal hygiene and cosmetic use.
For a streamlined registration process, Hegemoni Regulatory & Business Solutions provides comprehensive assistance with documentation, quality assessments, and licensing, facilitating faster market entry for international companies.
Schedule a meeting with our regulatory experts to learn more about streamlining your product registration journey.
Importing Veterinary Products: General Guidelines for Compliance
For companies looking to import veterinary products into Brazil, compliance with MAPA’s regulatory framework is crucial. Key requirements include:
- Product Licensing: All licensed products, or those exempt from registration, must receive clearance through SISCOMEX, Brazil’s official system for import licensing.
- Documentation and Approval: Importers are responsible for submitting a Licensing of Import (LI) request, which details the product’s origin, intended purpose, and regulatory status.
Certain veterinary products are exempt from MAPA registration, including those for research, unbranded homeopathic treatments, and specific hygiene products. However, even exempt products are subject to quality controls and require SISCOMEX documentation.
Note: MAPA also requires pre-authorization for sensitive products, including biological agents or those containing controlled substances, ensuring these items meet safety standards upon entry.
Schedule a meeting with our regulatory experts to learn more about streamlining your product registration journey.
Pharmacovigilance and Post-Market Surveillance
To safeguard public and animal health, Brazil mandates pharmacovigilance for all veterinary products, requiring companies to monitor, report, and investigate adverse events post-sale. According to Decree No. 5.053, companies must establish rigorous protocols to identify and manage risks associated with their products.
MAPA’s PORTARIA No. 399 outlines guidelines for reporting adverse events, detailing obligations for reporting, investigation, and recall actions. Compliance in pharmacovigilance is a cornerstone of maintaining product approval and ensuring the well-being of animal populations in Brazil.
Schedule a meeting with our regulatory experts to learn more about streamlining your product registration journey.
Conclusion: Navigating Brazil’s Veterinary Products Market with Hegemoni
The Veterinary Products Market in Brazil for 2023/2024 offers substantial opportunities for growth, especially for international companies that prioritize regulatory compliance. However, entering this market requires in-depth knowledge of MAPA’s complex requirements, from registration to pharmacovigilance. Hegemoni Regulatory & Business Solutions is equipped to help businesses successfully navigate these regulations, providing end-to-end assistance in product registration, import licensing, and ongoing compliance to ensure success in Brazil’s rapidly evolving veterinary sector.
Schedule a meeting with our regulatory experts to learn more about streamlining your product registration journey.