How to avoid rejections when registering products with MAPA?

One of the most common reasons for rejection is incomplete or inadequate documentation. Companies that begin the process without a prior technical diagnosis run the risk of investing time and resources in preparing a dossier that does not meet MAPA's specific requirements for their type of product. This includes everything from insufficient stability studies for the intended shelf life to mismatched information between the label, package insert (when applicable), and declared formulation. Without an internal audit or specialized consulting to verify compliance, it is common for the process to be filed with flaws that will only be identified months later by the MAPA analyst, resulting in a notification of requirement or, worse, direct rejection.

This strategic diagnosis should be the first step. It acts as an “X-ray” of your product and process, identifying and correcting potential non-conformities before submission. It is an action that transforms uncertainty into predictability.

I WANT A PRELIMINARY DIAGNOSIS WITH SPECIALISTS

In any regulatory process, prior art analysis is essential. In the context of MAPA, this means ensuring that the proposed trade name, functional property claims, or indications for use do not conflict with specific standards or mislead consumers. For example, a food product that claims therapeutic properties may be rejected because it could be confused with the definition of a medicine. Similarly, the misuse of protected terms, such as designations of origin or ingredients with restricted use, is a sure path to rejection.

This analysis requires in-depth knowledge of industry standards. For an animal cosmetic, restrictions may be found in the list of permitted active ingredients, or for another veterinary product, in the dosage and indication for each animal species. Ignoring this step is to underestimate the technical rigor of the regulatory agency and take an unnecessary risk.

I NEED A TECHNICAL ANALYSIS

Obtaining registration is rarely a straightforward process. It is common for MAPA to issue technical or additional requirements during the review process. Rejection often occurs not because of the merits of the product, but because of inefficiency in the management of the administrative process. This includes failing to respond to requests from the agency within the stipulated deadlines, filing contradictory or disorganized information, or simply losing track of progress due to a lack of systematic monitoring.

Unjustified delays in interacting with the regulatory authority can be interpreted as a lack of interest or inability to prove the safety and quality of the product, leading to the filing or rejection of the process. Having professional management of the process, which operates with organization, agility in responses, and clear communication with MAPA, is not a bureaucratic detail, but a critical pillar for success.

TURN BUREAUCRACY INTO EFFICIENCY

The path to MAPA registration, although complex, does not need to be a source of uncertainty for your business. Understanding and anticipating the points of attention is the key to turning a mandatory requirement into a strategic advantage. This is where the experience of a specialized partner becomes an indispensable differential.

Stone Okamont acts as a strategic extension of your team, offering much more than just document protocol. Our methodology is based on risk prevention. We begin with an in-depth regulatory feasibility analysis, identifying potential obstacles before any significant investment is made. We rigorously prepare and review the entire technical dossier, ensuring that the documentation is complete, consistent, and aligned with the latest MAPA guidelines.