Requirements for Veterinary Product Registration

Requirements for Veterinary Product Registration

The veterinary product market is constantly growing, keeping pace with the evolution of care for both pets and livestock. To legally and safely market these products, they must undergo a rigorous registration process. In this blog, we will detail the main requirements for registering veterinary products in Brazil.

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What you will see in this blog:

  • Understand the Legislation
  • Necessary Documentation
  • Safety and Efficacy Studies
  • Quality Control
  • Fees and Deadlines

Understand the Legislation

The first step in registering veterinary products is understanding the current legislation. In Brazil, the responsibility for the registration of veterinary products lies with the Ministry of Agriculture, Livestock, and Supply (MAPA). Keeping up-to-date with regulations is essential to ensure your product's compliance.

Necessary Documentation

Documentation is a crucial part of the registration process. The main required documents include:

  • Application Form: A standard document provided by MAPA that must be correctly filled out.
  • Technical Dossier: Includes detailed information on the formulation, manufacturing method, quality control, and safety and efficacy studies of the product.
  • Certificate of Analysis: Issued by an accredited laboratory, proving the product's quality.
  • Label and Package Insert: Must follow regulatory specifications, providing information on composition, indications, usage instructions, contraindications, and precautions.

Safety and Efficacy Studies

Safety and efficacy studies are fundamental to ensuring that the veterinary product is safe for animals and effective for the proposed treatment or prevention. These studies must be conducted according to international and national protocols, and the results should be included in the technical dossier. Additionally, it is important that the studies are performed by qualified professionals in recognized institutions.

Quality Control

Quality control is another vital area. The product must undergo rigorous testing to ensure its stability, purity, and potency. These tests are conducted at different stages of production and on the final product, ensuring that it meets the standards set by MAPA. Quality control should also include batch traceability and detailed record-keeping of each process step.

Fees and Deadlines

Registering veterinary products involves the payment of administrative fees, which vary depending on the type of product and its purpose. The evaluation and approval timelines can also vary, depending on the product's complexity and the conformity of the submitted documentation.

Specialized Consulting

Given the complexity of the registration process, many companies opt to hire specialized consulting firms, such as Stone Okamont, which specializes in veterinary product regulation. Stone Okamont provides comprehensive support in preparing documentation, conducting necessary studies, and navigating the bureaucratic process, significantly increasing the chances of quick and effective approval. With its extensive experience and in-depth knowledge of sector regulations, Stone Okamont stands out as a reliable partner for companies seeking to expedite the registration of their veterinary products and ensure compliance with all regulatory requirements.

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