N.Y. Comp. Codes R. & Regs. tit. 10 § 1004.6

Current through Register Vol. 46, No. 45, November 2, 2024

Section 1004.6 - Consideration of registered organization applications

(a) Applicants for approval to operate as registered organizations shall submit an application to the department, containing the information required in section 1004.5 of this Part, in a manner and format determined by the department.

(1) Applications shall be accompanied by a non-refundable application fee in the amount of $10,000.

(2) The registration fee for the registration period shall be $200,000. Applicants shall submit the registration fee by certified check, or another method approved by the Department, at the time of submission of the application. The registration fee shall be returned to the applicant if the applicant is not granted a registration under this Part.

(3) Only applications completed in accordance with this part as determined by the department and for which the application and registration fees have been submitted shall be considered if submitted in a timely manner. The department shall return the fee for $200,000 to all applicants who are not granted a registration.

(b) The department shall initially register up to five applicants as registered organizations. In deciding whether to grant an application, or amendment to a registration, the department shall consider whether:

(1) the applicant will be able to manufacture approved medical marihuana products, each with a consistent cannabinoid profile (the concentration of total tetrahydrocannabinol [THC] and total cannabidiol [CBD] will define the brand) and each able to pass the required quality control testing;

(2) the applicant will produce sufficient quantities of approved medical marihuana products as necessary to meet the needs of certified patients;

(3) the applicant will be able to maintain effective control against diversion of marihuana and medical marihuana products;

(4) the applicant will be able to comply with all applicable State and local laws and regulations;

(5) the applicant is ready, willing and able to properly carry on the activities set forth in this Part;

(6) the applicant possesses or has the right to use sufficient real property, buildings and equipment to properly carry on the activity described in its operating plan;

(7) it is in the public interest that such registration be granted;

(8) the number of registered organizations in an area will be adequate or excessive to reasonably serve the area, including whether there is sufficient geographic distribution across the State;

(9) the moral character and competence of board members, officers, managers, owners, partners, principal stakeholders, directors, and members of the applicant's organization;

(10) the applicant has entered into a labor peace agreement with a bona-fide labor organization, as defined in section 3360 of the Public Health Law, that is actively engaged in representing or attempting to represent the applicant's employees; and

(11) evaluation of the applicant's proposed operating plan and suitability of the proposed manufacturing and dispensing facilities, including but not limited to the suitability of the location and architectural and engineering design of the proposed facilities. Department approval of the applicant's operating plan and architectural and engineering design of the proposed facilities shall be required for issuance of a registration.

(c) The applicant shall allow reasonable access to the department and/or its authorized representatives for the purpose of conducting an on-site survey or inspection of the applicant's proposed manufacturing and/or dispensing facilities.

(d) If the commissioner is not satisfied that the applicant should be issued a registration, he or she shall notify the applicant in writing of those factors upon which further evidence is required. Within 30 days of the receipt of such notification, the applicant may submit additional material to the commissioner or demand a hearing, or both.

(e) Upon application to the department, a registered organization's registration may be amended to allow the registered organization to relocate within the State or to add or delete permitted registered organization activities or facilities. The department shall consider whether to grant or deny the application for amendment of the registration utilizing the criteria set forth in subdivision (b) of this section. The fee for such amendment shall be $250.

(f) Registrations issued shall be valid for two years from the date of issuance. To facilitate renewals of registrations, the commissioner may upon the initial application for a registration, issue some registrations which may remain valid for a period of time greater than two years, but not exceeding an additional 11 months. The registration fee will be prorated for the additional time exceeding two years.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 1004.6

Adopted, New York State Register April 15, 2015/Volume XXXVII, Issue 15, eff. 4/15/2015

Amended New York State Register December 27, 2017 /Volume XXXIX, Issue 52, eff. 12/27/2017