The Cost of Neglecting Legal Risk in a “Simple” Response to Notices from Anvisa or MAPA

Companies operating in regulated sectors — in this case, regulated by ANVISA and MAPA — constantly receive official notices from these agencies requesting information, clarification, or documents. Many companies view this as a simple administrative formality, especially because, in most cases, the content of these notices appears straightforward and easy or quick to address.

That is precisely where the risk lies. Notices of this nature, in fact, represent the effective beginning of a technical and legal dialogue with significant potential to determine relevant consequences for a company’s operations and/or rights.

We have observed, with concern, a growing tendency to simplify this stage precisely as the risks and consequences — both reputational and economic — arising from merely formal responses, or responses that fail to address the indirect risks associated with the requests contained in these notices, continue to increase.

In many cases, these notices are connected to ongoing administrative investigations initiated to examine facts arising from complaints or identified through ANVISA’s and MAPA’s own monitoring activities. It is precisely at this early stage that the foundations and interpretations of the case are often already being established by the authorities.

In other circumstances, however, no administrative investigation has even been initiated beforehand. In such cases, the company’s response to the notice will determine whether the investigation proceeds and whether the matter may develop into a series of other proceedings of different natures — administrative, judicial, civil, or criminal, for example.

There is also a third scenario: one in which the company’s response to an initial notice subsequently binds and/or limits its entire future line of argument. What is stated at this initial stage tends to define — and often restrict — the arguments and defenses available in any proceeding or procedure that may arise from that notice, including outside the regulatory agency’s jurisdiction, such as judicial proceedings or investigations conducted by the Public Prosecutor’s Office.

It is therefore essential to understand that, in practice, the content of a response to an official notice carries a much greater legal weight than it may initially appear to — even when the notice seems to address only technical and regulatory matters.

In many cases, notices are issued to obtain information or documentation that may, if necessary, serve as the basis for initiating administrative sanctioning proceedings. Providing an appropriate and strategic response to the requests for clarification during the investigative phase may even result in the immediate dismissal of the matter.

However, the risk of inaction or an inadequate response is even more serious when dealing with regulatory agencies. ANVISA operates under the precautionary principle, and the absence or insufficiency of accurate information may lead the Agency to take preventive action to protect public health, including severe preventive and precautionary measures. These measures may subsequently have a significant impact on other potential developments, such as proceedings before the Public Prosecutor’s Office or law enforcement authorities.

Beyond the legal consequences, negligence in responding to “simple” official notices may also result in economic losses. Administrative proceedings frequently involve some form of contingency, particularly in sanctioning proceedings. Furthermore, such developments may extend beyond the company’s current financial results and affect potential due diligence processes in M&A transactions, for example.

A response to what may appear to be a “simple” notice from a regulatory agency should therefore be regarded by the company as a strategic legal asset. Above all, it represents an opportunity for preventive defense: a moment when the company can clarify the facts, present its technical and legal position, and, most importantly, prevent mistaken interpretations from becoming established within regulatory bodies or in potential external proceedings.

Addressing these notices with rigor, depth, and a strategic perspective reduces risks, strengthens the legal certainty of the company’s operations, and preserves the integrity of its business activities in an increasingly complex and demanding regulatory environment. It also helps prevent matters from being escalated disproportionately to the underlying reality, particularly in sectors where trust and reputation are the company’s primary assets.

This material is for informational purposes only and should not be used independently as a basis for decision-making. Specific legal advice may be provided by one of our attorneys. All copyrights are reserved by KESTENER VIEIRA TORRONTEGUY SPEGIORIN ADVOGADOS.