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Special Authorization Requirement for Virtual Manufacturers and Virtual Distributors

An McV Health Care Alert

The Puerto Rico Department of Health (the “Department of Health”) issued Administrative Order No. 564 (the “Administrative Order”) to require virtual manufacturers and virtual distributors of certain pharmaceutical products to obtain a special authorization for conducting business in Puerto Rico. The Department of Health began receiving special authorization applications on March 15, 2023.

The Administrative Order defines virtual manufacturers as resident and non-resident entities that sell their own drugs, homeopathic products, veterinary drugs, natural products, supplements, and/or medical devices (collectively, the “Pharmaceutical Products”), but subcontract the manufacturing activities of such Pharmaceutical Products to a third party. Virtual manufacturers never come into contact with such Pharmaceutical Products in Puerto Rico. Virtual Distributors are entities engaged in the purchase and sale of Pharmaceutical Products without coming into physical contact with them. These virtual distributors do not manufacture, store, prescribe, or promote Pharmaceutical Products, but are experts in third party logistics (3PL). 

The special authorization is valid for one (1) year after its issuance. To obtain the special authorization, the virtual manufacturers and virtual distributors must file an application with the Department of Health.

The content of this McV Alert has been prepared for information purposes only. It is not intended as, and does not constitute, either legal advice or solicitation of any prospective client. An attorney-client relationship with McConnell Valdés LLC cannot be formed by reading or responding to this McV Alert. Such a relationship may be formed only by express agreement with McConnell Valdés LLC.

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