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Representative Agent
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.
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Maintain permit current related to required professional office for record keeping purposes.
​Execute product registration at the office of SARAFS.
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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
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