How to Regularize Health Products for Production Animals?

Health products for production animals include veterinary medicines, vaccines, feed additives, nutritional supplements, and others. These products are used to prevent, treat, and control diseases in animals such as cattle, swine, poultry, and others involved in the food production chain.

Regularizing animal health products is crucial for several reasons:

• Food Safety: Ensures that products used in animal production do not pose risks to human health.
• Animal Health: Ensures that products are effective and safe for animals.
• Legal Compliance: Avoids legal penalties, such as fines and product seizures.
• Market Confidence: Regularized products increase the confidence of producers and consumers.

1. Product Classification Determine the classification of the product according to the categories established by MAPA. This classification dictates the specific registration requirements.
2. Documentary Requirements Prepare the necessary documentation, which may vary depending on the product but generally includes:
• Application Form: Standard MAPA document.
• Technical Dossier: Studies on the product's efficacy, safety, and stability.
• Labels and Leaflets: Must comply with current regulations and provide clear and accurate information.
• Manufacturing Data: Details about the manufacturing process and quality control.
3. Submission of Documentation Submit the documentation to MAPA for evaluation. It is crucial that all documents are complete and accurate.
4. Technical Evaluation The technical team at MAPA reviews the documentation and may request additional information or complementary tests. This phase is critical to ensure the product meets all safety and efficacy requirements.
5. Facility Inspection MAPA may conduct inspections of the manufacturing facilities to ensure compliance with standards.
6. Product Registration After approval in all stages, the product is registered and authorized for commercialization. This registration must be renewed periodically, according to MAPA guidelines.

• Early Preparation: Gather the necessary documentation well in advance to avoid delays.
• Specialized Consulting: Hire Stone Okamont, a company specializing in regulatory consulting, to assist with the process. Their expertise can help navigate the complex MAPA requirements and ensure compliance with all regulations.

Regularizing health products for production animals at MAPA is a detailed but essential process to ensure the safety and efficacy of products in the market. Strictly following the steps and staying updated on regulations can facilitate approval and prevent future issues.

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