Rutgers Law

New Jersey Statutes, Title: 24, FOOD AND DRUGS

    Chapter 6I:

      Section: 24:6I-7.3: Clinical registrant permits.

          13. a. The commission shall issue clinical registrant permits to qualified applicants that meet the requirements of this section. In addition to any other requirements as the commission establishes by regulation regarding application for and issuance of a clinical registrant permit, each clinical registrant applicant shall:

(1) complete a criminal history record background check that meets the requirements of subsection d. of section 7 of P.L.2009, c.307 (C.24:6I-7);

(2) submit to the commission any required application and permit fees;

(3) submit to the commission written documentation of an existing contract with an academic medical center that meets the requirements of subsection c. of this section; and

(4) submit to the commission documentation that the applicant has a minimum of $15 million in capital.

b. The commission shall, no later than 90 days after the effective date of P.L.2019, c.153 (C.24:6I-5.1 et al.) or upon adoption of rules and regulations as provided in subsection c. of section 18 of P.L.2009, c.307 (C.24:6I-16), whichever occurs first, begin accepting and processing applications for five clinical registrant permits. Thereafter, the commission shall accept applications for and issue such additional clinical registrant permits as it determines to be necessary and consistent with the provisions of P.L.2009, c.307 (C.24:6I-1 et al.). The commission shall make a determination as to a clinical registrant permit application no later than 90 days after receiving the application, which may include a determination that the commission reasonably requires more time to adequately review the application. In reviewing and approving applications for clinical registrant permits, the commission shall seek to incorporate the policies, practices, protocols, standards, and criteria developed by the Office of Minority, Disabled Veterans, and Women Cannabis Business Development pursuant to section 32 of P.L.2019, c.153 (C.24:6I-25) to promote participation in the medical cannabis industry by persons from socially and economically disadvantaged communities. In no case shall the commission accept, process, or approve an application submitted by an applicant that has contracted with an academic medical center that is part of a health care system that includes another academic medical center that has contracted with an applicant for, or a holder of, a clinical registrant permit.

c. A contract between a clinical registrant and an academic medical center shall include a commitment by the academic medical center, or its affiliate, to engage in or oversee clinical research related to the use or adverse effects of cannabis in order to advise the clinical registrant concerning patient health and safety, medical applications, dispensing and management of controlled substances, and ways to mitigate adverse health or societal effects of adult, personal use legalization, among other areas. A clinical registrant issued a permit pursuant to this section shall have a written contractual relationship with no more than one academic medical center.

d. A clinical registrant issued a permit pursuant to this section shall be authorized to engage in all conduct involving the cultivation, manufacturing, and dispensing of medical cannabis as is authorized for an entity holding medical cannabis cultivator, medical cannabis manufacturer, and medical cannabis dispensary permits pursuant to P.L.2009, c.307 (C.24:6I-1 et al.), including dispensing medical cannabis and medical cannabis products to qualifying patients and designated and institutional caregivers. The clinical registrant shall additionally be authorized to engage in clinical research involving medical cannabis using qualifying patients who consent to being part of such research, subject to any restrictions established by the commission.

e. (1) A clinical registrant issued a permit pursuant to this section may conduct authorized activities related to medical cannabis at more than one physical location, provided that each location is approved by the commission and is in the same region in which the academic medical center with which the clinical registrant has a contract is located.

(2) A clinical registrant may apply to the commission for approval to relocate an approved facility to another location in the same region, which application shall be approved unless the commission makes a specific determination that the proposed relocation would be inconsistent with the purposes of P.L.2009, c.307 (C.24:6I-1 et al.). The denial of an application for relocation submitted pursuant to this paragraph shall be considered a final agency decision, subject to review by the Appellate Division of the Superior Court.

(3) The commission may authorize a clinical registrant to dispense medical cannabis and medical cannabis products from more than one physical location if the commission determines that authorizing additional dispensing locations is necessary for the clinical registrant to best serve and treat qualifying patients and clinical trial participants.

(4) In no case shall a clinical registrant operate or be located on land that is valued, assessed or taxed as an agricultural or horticultural use pursuant to the "Farmland Assessment Act of 1964," P.L.1964, c.48 (C.54:4-23.1 et seq.).

f. A clinical registrant permit shall not be sold or transferred to any other entity.

g. Clinical registrant permits shall be valid for the term of the contractual relationship between the academic medical center and the clinical registrant. The commission may renew a clinical registrant permit to correspond to any renewal of the contractual relationship between the academic medical center and the clinical registrant.

h. Each clinical registrant shall submit the results of the clinical research obtained through an approved clinical registrant permit to the commission no later than one year following the conclusion of the research study or publication of the research study in a peer-reviewed medical journal. Nothing in this subsection shall be deemed to require the disclosure of any clinical research that would infringe on the intellectual property of the clinical registrant or on the confidentiality of patient information.

i. Application materials submitted to the commission pursuant to this section shall not be considered a public record pursuant to P.L.1963, c.73 (C.47:1A-1 et seq.), P.L.2001, c.404 (C.47:1A-5 et al.), or the common law concerning access to records.

L.2019, c.153, s.13; amended 2021, c.16, s.17.

This section added to the Rutgers Database: 2021-03-17 11:06:16.

Older versions of 24:6I-7.3 (if available):

Court decisions that cite this statute: CLICK HERE.