Ecuador – ARCSA establishes a temporary and definitive regulatory regime for the registration of importers and distributors in health notifications

The competent health authority, in coordination with the Foreign Trade Committee, has issued a binding regulatory directive to definitively establish the administrative regime applicable to the processing of applications for the inclusion or registration of importers and distributors in health notification certificates, health records, and mandatory health notifications. This legal measure is directly framed within the official implementation phase of the strategic guidelines set forth in Resolution 017-2025, a commercial control instrument originally issued in December of the previous year and formally published in the Official Register 188 for national observance. In strict application of the Second Transitional Provision of the aforementioned regulation, the mandate establishes an exceptional and temporary regime with an exact duration of one hundred and twenty calendar days, counted rigorously from the date the legal document comes into effect. During this transitional period of administrative adaptation, all procedures aimed at the inclusion or updating of import and distribution entities in the current health records will be processed under the technical figure of record modification. To facilitate the operational regularization of commercial agents in the regulated sector, the governmental body stipulates that, for the purpose of collecting official fees, a financial amount equivalent to ten percent of the originally set tariff value for obtaining the respective primary certificate will be applied. Under this temporary scheme, the regulation expressly authorizes product holders to simultaneously incorporate one or more associated importers and distributors thru the submission of a single application, significantly reducing the bureaucratic and economic burdens for companies. However, the legal text explicitly warns that, once this peremptory transition period of one hundred and twenty days has expired, the technical incorporation of new actors in the marketing chain will be irrevocably subject to the permanent provisions stipulated in Article 4 of Ministerial Agreement 112. Consequently, under this definitive and post-transitional framework, the regulatory entity will require the individualized payment of the fee corresponding to ten percent of the base amount of the sanitary registration for each additional importer or distributor intended to be added to the file, consolidating a strict monitoring scheme that requires companies to strategically plan their distribution logistics before the conclusion of the tariff flexibility period.