DOH Finalizes Temporary Regulations For Clinical Registrants And Academic Clinical Research Centers

Cozen O'Connor
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The Pennsylvania Department of Health (DOH) published the much anticipated final version of the temporary regulations under the Medical Marijuana Act applicable to Clinical Registrants and Academic Clinical Research Centers (ACRC) in Pennsylvania (“Temporary Regulations”). The Clinical Registrant/ACRC relationship was first developed in Pennsylvania with a specific focus on research.  A Clinical Registrant is a unique category of Medical Marijuana Organization under Pennsylvania law that is granted a permit to act as both a grower/processor and dispensary. An ACRC is “an accredited medical school” in Pennsylvania that “operates or partners with an acute care hospital licensed and operating” in Pennsylvania. The Temporary Regulations require Clinical Registrants and ACRCs to enter into Research Contracts together and provide some broad guidance about the content of those written agreements. Additionally, the Temporary Regulations address certification of ACRCs, capital requirements, approvals for clinical registrants, and the process for Clinical Registrant applicants who wish to convert their already issued grower/processor or dispensary permits to Clinical Registrant permits.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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