WHAT DOCUMENTS ARE REQUIRED TO REGISTER A VETERINARY PRODUCT WITH THE MAPA?

This is the core of your application for registration. Here, you need to convince MAPA that your product works as promised and is safe for the animals, their handlers and the end consumer of food of animal origin. Technical documents are the scientific evidence that supports all the claims made about the product.

• This includes: Detailed results of all the studies carried out. This covers efficacy studies (proof that the product actually works against the proposed disease or condition, carried out under controlled conditions and in the field), safety studies (evaluation of possible side effects in the treated animals and in different species, including overdose tests), residue studies (crucial for products used in farm animals - they show how long the product or its components take to leave the animal's body, ensuring that foods such as meat, milk or eggs will be safe to consume within the established timeframe) and stability studies (which prove how long the product maintains its quality, efficacy and safety within the proposed packaging, under specific storage conditions). In addition, it is essential to present the product's complete technical data sheet, with all the information on its composition, indications for use, method of application, precautions, restrictions, grace period (time the animal cannot be slaughtered or its products consumed after treatment) and warnings. A summary technical report that integrates and explains all this data is also essential.

MAPA needs to be sure that each batch of the product that reaches the market will be identical to the one that has been tested and approved. This is where the documents that certify the consistent quality of the production process come in.

• What it includes: Detailed, standardized descriptions of how the product is manufactured, step by step. Precise specifications of all the ingredients used (raw materials) and the final product, defining exactly what is acceptable in terms of purity, concentration, appearance, etc. The analytical methods used to test and guarantee that both the ingredients and the final product meet these specifications need to be presented and validated. Good Manufacturing Practice (GMP) certificates must be presented for the places where the product is manufactured and packaged. These certificates, issued by MAPA after rigorous inspections, prove that the company follows international standards of quality, hygiene and control throughout its production. Analysis reports on pilot or experimental batches are also required to demonstrate the ability to produce as planned.

This group gathers the paperwork that formalizes the order, clearly identifies everyone involved and ensures that the product is presented to the end consumer in a clear and compliant manner.

• This includes: The formal application for registration addressed to the MAPA. Proof of registration of the applicant company in Brazil (CNPJ) and of the manufacturing company in its country of origin. Proof of the right to use the product's trademark in Brazil (registration with the INPI or proof of application). Specific powers of attorney if the process is being conducted by a legal representative or consultant. The proposed package leaflet (intended for the veterinarian) and the proposed label (affixed to the packaging) are absolutely critical. They must contain all the mandatory information defined by the MAPA, with emphasis on the name of the product, composition, indications, warnings, restrictions, grace period, batch number, expiry date, name and contact details of the registration holder, and method of use, in an accurate, legible and non-misleading manner. Proof of payment of MAPA fees is also part of this package.

As is evident, the process of registering a veterinary product with the MAPA is a complex journey, full of technical, scientific and bureaucratic details that require specific expertise and in-depth knowledge of the requirements and modus operandi of the regulatory body. An error in the documentation, a poorly planned study or the lack of a certificate can mean months of delays, significant additional costs or, worse, the rejection of the application, preventing the product from reaching the market.

It is in this challenging scenario that Stone Okamont stands out as an indispensable strategic partner. Our team is made up of veteran regulatory specialists with extensive practical experience in all MAPA procedures. Hiring Stone Okamont goes far beyond outsourcing a bureaucratic task. It's establishing a strategic partnership with experts who turn the regulatory challenge into a competitive advantage.