N.Y. Comp. Codes R. & Regs. tit. 10 § 1004.7

Current through Register Vol. 46, No. 43, October 23, 2024

Section 1004.7 - Applications for renewal of registration as registered organization

(a) An application to renew any registration issued under this Part shall be filed with the department not more than six months nor less than four months prior to the expiration thereof. If a renewal application is not filed at least four months prior to the expiration thereof, the department may determine that the registration shall have expired and become void on such expiration date.

(b) Applications shall be accompanied by a non-refundable application fee in the amount of $10,000. Applications shall also be accompanied by a registration fee in the amount of $200,000 made by certified check. 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 registration fee shall be returned to the applicant if the applicant is not granted a renewal registration under this section.

(c) The application for renewal shall include such information prepared in the manner and detail as the commissioner may require, including but not limited to:

(1) any material change as determined by the department in the information, circumstances or factors listed in section 1004.5 of this Part;

(2) every known complaint, charge or investigation, pending or concluded during the period of the registration, by any governmental or administrative agency with respect to:

(i) each incident or alleged incidence involving the theft, loss, or possible diversion of medical marihuana manufactured, distributed, or dispensed by the registered organization; and

(ii) compliance by the applicant with local or State laws, or regulations of the department, including but not limited to, with respect to any substance listed in section 3306 of the Public Health Law;

(3) information concerning the applicant's ability to carry on the manufacturing and distributing activity for which it is registered, including but not limited to approved medical marihuana product shortages or wait lists occurring during the registration period; and

(4) a summary of quality assurance testing for all medical marihuana products produced in the prior year including but not limited to the percentage of lots of each brand and form passing all required testing, the percentage of lots failing contaminant testing, the percentage of lots failing brand requirements, all recalls of product lots and all adverse events reported.

(d) The department shall consider applications for renewal in accordance with the criteria set forth in section 3365 of the Public Health Law.

(e) If the department determines that the applicant's registration should not be renewed, the department shall serve upon the applicant or his or her attorney of record, in person or by registered or certified mail, an order directing the applicant to show cause why his or her application for renewal should not be denied. The order shall specify in detail the respects in which the applicant has not satisfied the department that the registration should be renewed.

(1) within 10 business days of receipt of such an order, the applicant may submit additional material to the department or demand a hearing, or both. If a hearing is demanded, the commissioner shall fix a date as soon as reasonably practicable.

(2) If the applicant fails to submit additional material to the department within 10 business days as requested, and the applicant does not demand a hearing within such time period, the application for renewal of registration shall be denied.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 1004.7

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