Puerto Rico Product Registration: Undocumented Rule and Enforcement Change

Written-by: Deneen Fumich, RPh

Understanding Registration Basics

Pursuant to Puerto Rico Chapter 5, Article 5.01 Manufacturing, Distribution and Dispensing of Drugs, each pharmaceutical prescription, otc and device product that is marketed or sold in Puerto Rico must be registered with the Department of Health. Further under Section (b), the registration of pharmaceutical drug and devices must be registered by a licensed local representative agent for the manufacturer.

Pharma Solutions has an office and a licensed registered agent staff in Puerto Rico to assist manufacturers and distributors with product registration for the marketing, sales and shipment of product into and within Puerto Rico.

At Pharma Solutions, we stay on the cutting edge of regulatory changes and advancements.

Important Changes

In the fall of 2020, Puerto Rico issued a public notice of its intent to amend Regulation Number 156 regarding the operation of manufacturers to distribute and dispense medications. At that time the rule was in conflict to the intent of the passed legislation and Pharma Solutions provided comments to the proposed regulation change.

At present, we are experiencing an undocumented rule and enforcement change. In order to renew your Representative Agent Certificate or be issued new Product Registrations, nonresident entities are now required to either have a physical presence licensed as a wholesale distributor by PR DOH in Puerto Rico or be engaged with a Distributor customer who is physically located in Puerto Rico for approval of a Representative Agent Certificate.

If you would like your products to be registered with a company that stays on top of changes in Puerto Rico, we are your trusted compliance solution. Please contact us at hello@pharma.solutions.

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