Technical aspects to be considered in the registration of veterinary products with MAPA

The first crucial step is to determine whether your product is, in fact, subject to registration. The legislation stipulates that most products intended for the prevention, diagnosis, cure, or treatment of animal diseases require this authorization. This covers a wide range of products, including medicines, vaccines, antiseptics, and diagnostic kits.

However, some specific products are exempt from formal registration, requiring only registration with MAPA. Knowing this distinction prevents your company from initiating an unnecessary and time-consuming process. Included in this category are:

• Hygiene and beauty products: Shampoos, soaps, conditioners, and similar products that do not claim any therapeutic action or modification of organic functions.
• Homeopathic products without a trademark.
• Products imported for research or individual use, in limited quantities and not for commercial sale.

It is essential to note that, even for products exempt from registration, the establishment that manufactures, imports, or markets them must be duly registered with MAPA.

I WANT TO REGISTER MY VETERINARY PRODUCT

Documentation is at the heart of the registration process. An incomplete or flawed submission is one of the most common causes of rejection and delays. The formal application is filed through the SEI-MAPA Electronic Filing module, selecting the process type “Veterinary Product – Product Registration.”

The required documentation includes:

• Registration Application: Standard form provided by MAPA, duly completed.
• Complete Technical Dossier: This is the most critical element and must contain:
• Technical Report: Detailed information on the qualitative and quantitative formulation, manufacturing method, and quality control at all stages.
• Stability Studies: These prove that the product maintains its physical-chemical and microbiological characteristics throughout its proposed shelf life.
• Safety and Efficacy Studies: These are essential to demonstrate that the product is safe for animals and effective for the proposed indication, following national and international protocols.
• Pilot Batch Analysis Certificate: Issued by an accredited laboratory, certifying the quality of the product.
• Labeling and Package Insert Design: Must strictly follow regulatory specifications, providing information on composition, indications, method of use, contraindications, precautions, and grace period, if applicable.

I WANT TO ORGANIZE MY DOCUMENTATION WITH STRATEGY

In addition to gathering the correct documentation, a proactive strategy is vital to avoid the most common mistakes. Many companies underestimate the importance of strict quality control and traceability of all batches produced, elements that are frequently audited by MAPA.

Another point of attention is substances subject to special control. According to specific legislation, exclusive procedures are established for the commercialization of products containing such substances, and including them in a formulation requires additional safety and control evidence.

After submission to SEI-MAPA, the process is analyzed by technicians from the Department of Livestock Input Inspection. A well-structured Action Plan, anticipating and responding quickly to possible additional requirements from the agency, can prevent the process from being shelved due to lack of response within the legal deadlines. After approval, the establishment can digitally issue the operating license through the SIPEAGRO System.

Mastering the intricate regulatory landscape of MAPA requires more than technical knowledge; it requires practical experience and meticulous management of deadlines and documents. It is in this context that Stone Okamont establishes itself as a reliable partner for companies that cannot risk rejections, delays in commercialization, or bans.

Our services go beyond traditional consulting. We offer comprehensive and personalized support, acting from the initial diagnostic phase—identifying whether your product needs registration or just filing—to the complete management of the process before MAPA. Our specialists assist in the preparation and review of the technical dossier, ensuring that all safety, efficacy, and stability studies comply with legal requirements, and monitor the entire process at SEI-MAPA, ensuring a quick response to any requirement.

With Stone Okamont, your company transforms a complex bureaucratic process into a strategic journey, ensuring regulatory compliance and freeing your team to focus on what matters most: innovating and growing in the market.

Do you need to register your veterinary products? Contact Stone Okamont and streamline your process with MAPA. Our expertise is your surest path to approval.