In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP), announced that all nonresident wholesale distributors and manufacturers shipping prescription and over-the-counter (OTC) human and veterinary drugs, medical devices, and homeopathic and nutritional supplements into Puerto Rico would be required to obtain a nonresident license, known as a Special Authorization. Quarles previously detailed this new requirement here.
Entities subject to this rule were instructed to apply for the Special Authorization through the Puerto Rico Department of Health’s online portal, RenovacionesOnline. Despite early technical issues and processing delays, the system eventually stabilized, and Department staff became more responsive in assisting applicants.
However, on June 17, 2025, SARSP unexpectedly issued Administrative Order No. 612, repealing the Special Authorization requirement for nonresident virtual wholesalers and manufacturers, originally mandated under Administrative Order No. 564 (March 6, 2023). On the same day, SARSP also released a Special Notice Regarding Nonresident Distributors 2025 (Notificación Especial Sobre Aviso de Distribuidores no Residentes 2025), which extended the repeal to traditional (non-virtual) manufacturers and distributors as well. Although this notice has not yet been posted to the SARSP website, it was sent to all nonresident manufacturers and distributors that currently hold a Special Authorization.
In effect, these actions eliminate the Special Authorization requirement for all nonresident manufacturers and wholesale distributors of prescription and OTC human and veterinary drugs, medical devices, and homeopathic and nutritional supplements shipping products into Puerto Rico.
Both the Administrative Order and Special Notice took immediate effect. The Special Notice instructs the Department of Health to remove all pending and active Special Authorization applications from the RenovacionesOnline portal. However, as of this writing, both initial and renewal applications remain available online. It is currently unclear whether applicants with pending, in-process, or recently approved licenses will receive refunds. A SARSP representative has indicated that refund instructions have not yet been issued.
Important Note: These recent changes do not affect the requirement for manufacturers and certain wholesale distributors to register the products they ship into Puerto Rico. It also appears that manufacturers may still independently register products through the RenovacionesOnline portal without needing to use a Representative Agent. We are seeking clarification from SARSP on this point and will update this alert as more information becomes available.
