Md. Code Regs. 10.62.19.04

Current through Register Vol. 51, No. 12, June 14, 2024

Section 10.62.19.04 - Application Review

A. The burden of proving an applicant's qualifications rests on the applicant

B. The Commission may deny an application that contains a misstatement, omission, misrepresentation, or untruth.

C. An application shall be complete in every material detail.

D. The Commission may request any additional information the Commission determines is necessary to process and fully investigate an application.

E. The applicant shall provide requested additional information by the close of business of the 14th business day after the request has been received by the applicant.

F. If the applicant does not provide the requested information within 14 business days, the Commission may consider the application to be suspended.

G. The Commission intends to award the licenses to the best applications that most efficiently and effectively ensure public safety and safe access to medical cannabis and medical cannabis-infused products.

H. The Commission shall provide guidelines and detailed instructions for submitting the application form for the Commission's consideration.

I. The Commission, or a Commission independent contractor, shall review for a pre-approval for a license the submitted applications as described in Regulations .02B and .04E of this chapter. The applications shall be ranked based on the following weighted criteria:

(1) Operational Factors will be afforded 20 percent weight, including:

(a) A detailed operational plan for the production of medical cannabis extracts and medical cannabis-infused products; and

(b) Summaries of policies and procedures for:

(i) Laboratory operations;

(ii) Processing; and

(iii) Packaging;

(2) Safety and Security factors will be afforded 20 percent weight, including:

(a) Detailed plan or information describing the security features and procedures;

(b) Detailed plan describing how the processor will prevent diversion; and

(c) Detailed plan describing safety procedures;

(3) Commercial laboratory, pharmaceutical manufacturing and consumer products production factors will be afforded 15 percent weight, including, experience, knowledge and training in:

(a) Chemical plant management;

(b) Pharmaceutical manufacturing; and

(c) Consumer product production;

(4) Production control factors will be afforded 15 percent weight, including:

(a) A detailed quality control plan;

(b) A detailed inventory control plan; and

(c) A detailed green waste disposal plan;

(5) Business and economic factors will be afforded 15 percent weight, including:

(a) A business plan:

(i) Demonstrating a likelihood of success;

(ii) Demonstrating a sufficient business ability and experience on the part of the applicant; and

(iii) Providing for appropriate employee working conditions, benefits, and training;

(b) Demonstration of adequate capitalization; and

(c) A detailed plan evidencing how the processor will enforce the alcohol and drug free workplace policy;

(6) Additional factors that will be afforded 15 percent weight, including:

(a) A diversity plan as defined in COMAR 10.62.01.01;

(b) Documentation that the applicant:

(i) Has at least 51 percent of its ownership interest held by one or more individuals who are disadvantaged equity applicants; or

(ii) Made good faith efforts to have at least 51 percent of its ownership interest held by disadvantaged equity applicants, including a list of the names and addresses of all potential owners interviewed and identifying those who qualify as disadvantaged equity applicants and whether any of those potential owners have purchased an equity share in the entity submitting an application;

(c) Documentation that the applicant:

(i) Has at least 25 percent and not more than 50 percent of its ownership interest held by one or more individuals who are members of the most disadvantaged groups in the medical cannabis industry, as identified by the Commission; or

(ii) Made good faith efforts to have at least 25 and not more than 50 percent of its ownership interest held by members of the most disadvantaged groups in the medical cannabis industry, including a list of the names and addresses of all potential owners interviewed and identifying those who are members of the most disadvantaged groups and whether any of those potential owners have purchased an equity share in the entity submitting an application;

(d) Documentation that the applicant:

(i) Has at least 51 percent of its ownership interest held by one or more individuals who are members of the most disadvantaged groups in the medical cannabis industry, as identified by the Commission; or

(ii) Made good faith efforts to have at least 51 percent of its ownership interest held by members of the most disadvantaged groups in the medical cannabis industry, including a list of the names and addresses of all potential owners interviewed and identifying those who are members of the most disadvantaged groups, and whether any of those potential owners have purchased an equity share in the entity submitting an application; and

(e) Demonstration that the applicant meets three or more of the following criteria:

(i) At least 51 percent of its ownership interest is held by one or more individuals who have lived in an economically disadvantaged area for 5 of the preceding 10 years;

(ii) A majority of the current employees live in an economically disadvantaged area;

(iii) A majority of the current contractors live in an economically disadvantaged area;

(iv) At least 51 percent of its ownership interest is held by one or more individuals who are a member of a household that earns no more than 80 percent of the State median household income; and

(v) The applicant has significant past experiences in or business practices that promote economic development and empowerment in economically disadvantaged areas.

J. The Commission shall apply the application provisions set forth in §I(6)(b), (c), and (d) of this regulation to any pre-approval issued by the Commission on or before July 1, 2022.

Md. Code Regs. 10.62.19.04

Regulation .04 adopted effective 42:18 Md. R. 1176, eff.9/14/2015; amended effective 45:25 Md. R. 1201, eff. 12/17/2018; amended effective 46:6 Md. R. 346, eff. 3/25/2019; amended effective 48:23 Md. R. 980, eff. 11/15/2021