Configuration of the “Affirmative Ficta” figure, in relation to the procedures carried out before the Federal Commission for the Protection against Sanitary Risks.

The purpose of this Note is to inform you about the configuration of the legal status of the “Affirmative Ficta” and its relationship with the requests made to COFEPRIS.

A. Affirmative Ficta
It is important to mention that the "Affirmative Ficta" was defined by the Judge of the Plenary in Administrative Matters of the Fourth Circuit, Sergio Javier Coss Ramos, as follows:

“The fictitious affirmative, as a result of administrative silence, constitutes an effective means for all individuals to obtain a response to the requests they make to the public administration and, above all, to obtain it within the term established in the applicable legal regulations; the foregoing by virtue of the fact that through it the existence of an administrative act of favorable content for the individual who presented the unanswered request is presumably configured. "

In accordance with the foregoing, the "Affirmative Ficta" is the answer in a positive sense that is presumed derived from the silence of the administrative authority before whom a request has been formulated; as long as your special law provides for it.
B. Configuration of the Affirmative Ficta
In principle, it is necessary to mention that article 17 of the Federal Law of Administrative Procedure (hereinafter, LFPA), contemplates the configuration of the Affirmative Ficta when, once a request has been made before a certain authority, the term provided in the applicable laws, in order for the authority to whom the request was made to issue its resolution, the foregoing as long as the special law that regulates the formulation of the request made, provides that before the silence of the authority, said request is understand resolute in a positive sense.

In summary, so that the configuration of the figure of the “Affirmative Ficta” can be presumed, the following assumptions must be met:

a) That there is the formulation of a request before a certain administrative authority.
b) That the regulatory framework that regulates the request in question, provides that in the face of silence from the authority, the request is understood to be resolved in the affirmative sense.
c) That the term provided by the applicable regulations has expired and that the administrative authority before whom the request has been made, does not issue the corresponding resolution.

In addition to the above, it is important to point out that article 17 of the LFPA, contemplates that once the "Affirmative Ficta" has been configured if the interested party requests it, the administrative authority to whom the request in question has been made, it must issue the proof that proves the "Affirmative Ficta", which must be issued within two days after the one in which the request for said proof was made.

C. Configuration of the Affirmative Ficta in relation to the requests made before COFEPRIS

Now, for the requests made before COFEPRIS, the configuration of the "Affirmative Ficta" is provided in the Regulation Regarding Registries, Import and Export Authorizations and Export Certificates of Pesticides, Plant Nutrients and Substances and Materials. Toxic or Dangerous, only, regarding the processing of:

i. Administrative Modification, and
ii. Extension.

In this sense, in order for the requests made to COFEPRIS regarding administrative modifications and extensions of said records to be understood as having been resolved in a positive sense, the following requirements must be met:

a) That there is a formulation before COFEPRIS of the request in question, and;
b) That said authority has failed to issue any resolution within the term of twenty business days following that in which:
• The deadline to prevent the interested party expires, if necessary to correct omissions or make clarifications of the information or documentation corresponding to the procedure that is carried out, or else;
• The interested party has relieved the prevention or expired the term to do so.

In this order of ideas, once the aforementioned hypothesis has been updated and in accordance with article 17 of the LFPA, the interested party may request before COFEPRIS the issuance of the certificate through which the configuration of the “Affirmative Ficta ”, Which must be issued within the two days following the one in which it was requested.
By virtue of the foregoing, Briffault Abogados, SC is at your service to provide appropriate and timely advice, regarding requests to COFEPRIS regarding administrative modifications and extensions of pesticide and plant nutrient registrations and the false affirmations that in their case are configured. As well as, the Contentious Area for any abuse by the authority in charge of solving the procedures in question.