Puerto Rico regulation requires that all pharmaceutical manufacturers and distributors interested in marketing (ship-to) in Puerto Rico need to be represented by a locally approved agent and all products must be registered with the Department of Health and, Controlled Substances (CS) require a Controlled Substance license by the Office of Investigations (OI). The designated agent residing in Puerto Rico will represent the manufacturer/distributor for the purposes of recordkeeping.
Zodiac will be responsible for:
Maintain current, the Representative Agent License issued by the SARAFS office and CS licenses. This license is renewable each two years and yearly, respectively.
Maintain permit current related to required professional office for record keeping purposes.
Execute product registration at the office of SARAFS.
Maintain all records required by law at the office for the event of an inspection by DOH authorities.
Representative Agent Services – See Regulation Num. 156