Reform of Article 4 of Resolution COMEXI 376-2007 (Elimination of the endorsement mechanism)

As of the date of entry into force, importers are not allowed to use a Health Registration or Sanitary Notification belonging to a third party through an authorization letter, contract, power of attorney, mandate, endorsement, or any informal transfer mechanism. Only authorizations that are expressly and formally approved by ARCSA will be valid.

The use or modification of a Health Registration or Sanitary Notification in favor of an importer will only be accepted when ARCSA has formally authorized it, pursuant to the procedures established by the agency.

According to the transitory provisions of the Resolution, SENAE and ARCSA have a period of 30 calendar days from the effective date to coordinate the operational and regulatory implementation measures required.

Likewise, importers currently using Health Registrations or Sanitary Notifications belonging to third parties have 120 calendar days to carry out the corresponding procedure before ARCSA, in order to obtain formal authorization for their use. After this period has elapsed, control authorities will not accept any Health Registration or Sanitary Notification that does not have ARCSA’s authorization in favor of the importer.

From CorralRosales, we will keep you informed regarding the mechanism and procedure that ARCSA may issue for the inclusion of importers. It is our understanding that this process will require the modification of previously issued Health Registrations and/or Sanitary Notifications in order to incorporate the authorized importer.

It is important to note that this mechanism does not apply to cosmetic products, where the parallel importer scheme is used.

This Resolution will enter into force on December 9, 2025, without prejudice to its publication in the Official Gazette.