Regulation of Veterinary Products at MAPA

The regulation of veterinary products involves the certification and authorization for marketing medicines, vaccines, supplements, and other items aimed at animal health. The goal is to ensure that these products meet the quality, efficacy, and safety standards established by the competent authorities.

Regulation is fundamental for several reasons:

Animal Safety: Products approved by MAPA have undergone rigorous tests and evaluations, ensuring they are safe for animals.

Efficacy: Certification ensures that products work as promised, offering the expected therapeutic or nutritional benefits.

Legal Compliance: Companies that market products without regulation are subject to legal penalties, including fines and product seizures.

The regulation process at MAPA involves several steps that must be strictly followed:

Submission of Documentation: Companies must present a series of documents that include efficacy and safety studies, technical reports, and manufacturing data.

Technical Evaluation: MAPA's technical team evaluates the submitted documentation, potentially requesting additional information or conducting complementary tests.

Facility Inspection: MAPA may conduct inspections at manufacturing facilities to ensure good manufacturing practices (GMP) standards are followed.

Product Registration: After approval at all stages, the product is registered and authorized for marketing.

The list of documents may vary depending on the type of product, but generally includes:

Application Form: MAPA standard document.

Technical-Scientific Report: Includes efficacy and safety studies.

Labels and Leaflets: Must comply with current standards.

Manufacturing Data: Detailed information about the production process.

Good Manufacturing Practices (GMP) Certificates: Issued by competent authorities.

Advance Preparation: Start gathering the necessary documentation in advance.

Specialized Consulting: Consider hiring Stone Okamont, a company specialized in regulatory consulting, to assist in the regulation process. Our expertise can facilitate navigating the complex requirements of MAPA and ensure compliance with all necessary standards.

Team Training: Ensure your team is well trained in good manufacturing practices and regulatory compliance.

The regulation of veterinary products at MAPA is a detailed and demanding process but crucial to ensuring the safety and efficacy of products available on the market. Strictly following the process steps and staying updated on regulations can facilitate approval and avoid future problems.

For more information or assistance with the regulation of your veterinary products, contact our customer service center. We are here to help!