As of October 10^th, 2024, the Puerto Rico Department of Health communicated that license applications (known as “orders”) for virtual manufacturers and virtual distributors are now open.

Prior to this announcement, virtual manufacturers and virtual distributors were not able to transact business, nor register their products on the island of Puerto Rico.

With this new announcement, the market is now open to “virtual” businesses that have been unable to obtain the necessary licensing and registrations to do business on the island compliantly.

A Brief History

In early 2023, Puerto Rico advised that the application for virtual entities would be available as of 3/15/2023. Unfortunately, there was a delay in the release of the licensing program due to unforeseen circumstances within the Department.

The major effect was that these virtual entities have not been able to conduct business on the island per Puerto Rico Department of Health’s rules for over 18 months.

With this resolved, virtual manufacturers and virtual distributors can now apply for the “Special Virtual Distributor Authorization” or “Special Virtual Manufacture Authorization” — and, once issued, these entities can conduct business in Puerto Rico.

However, applicants should be wary that the Department has demanded that each application must be fully complete, including supporting documents, prior to it being submitted.

What is a Virtual Manufacturer or a Virtual Distributor

A virtual manufacturer takes ownership of the product and either holds the marketing authorization or is the manufacturer of record for a pharmaceutical product; they do not, however, physically manufacture the product. Instead, virtual manufacturers outsource most or all production, quality control, packaging, and distribution activities to third-party manufacturing organizations, also known as contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs).

A virtual distributor is a company that takes ownership of the product and facilitates the distribution of pharmaceutical products but does not physically take possession of those products. Virtual distributors operate primarily through partnerships and digital platforms, leveraging third-party logistic providers (3PLs) or other distribution partners to manage warehousing, inventory, and delivery to end customers like pharmacies, healthcare providers, or hospitals.

How LighthouseAI Can Help

LighthouseAI has operated a physical office in Puerto Rico and has been a licensed Representative Agent with the Puerto Rico Department of Health since 2018. We can help assist virtual manufacturers and virtual distributors submit their license applications with the agency, allowing those entities to do business compliantly on the island.

In addition to your license application, Puerto Rico also requires the following:

• Product registration
• Engaging a licensed Representative Agent on the island

If you need assistance with registering your business with the Puerto Rico Department of Health, please contact us.