Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part IXa - MEDICAL MARIJUANA
Chapter 1141a - GENERAL PROVISIONS
Section 1141a.29 - Initial permit application

Universal Citation: 28 PA Code ยง 1141a.29

Current through Register Vol. 54, No. 44, November 2, 2024

(a) The Department will publish in the Pennsylvania Bulletin notice of initial permit application availability and the time frame during which initial permit applications will be accepted.

(1) An applicant shall only use the initial permit application form prescribed by the Department on its web site.

(2) An applicant shall submit an initial permit application using the form posted on the Department's web site together with a version that is redacted in accordance with the Right-to-Know Law (65 P.S. §§ 67.101- 67.3104), as set out in § 1141a.22 (relating to records subject to disclosure; confidentiality), by mail in an electronic format that is prescribed by the Department in the initial permit application instructions.

(3) An initial permit application received from an applicant after the time frame during which the Department is accepting applications will be rejected by the Department and returned to the applicant without further consideration along with the initial permit application fee and initial permit fee submitted by the applicant with the permit application.

(b) In addition to the requirements in § 1141a.27 (relating to general requirements for application), the applicant shall provide the Department with the following information in the initial permit application:

(1) The legal name of the applicant.

(2) Certified copies of the applicant's organizational documents, if applicable, and, if the applicant was not organized in this Commonwealth, evidence that it is authorized to conduct business in this Commonwealth.

(3) The physical address of the applicant's proposed site and facility, including the following, as applicable:
(i) Evidence of the applicant's clear legal title to or option to purchase the proposed site and the facility.

(ii) A fully-executed copy of the applicant's unexpired lease for the proposed site and facility that includes the consent by the property owner to the use by the applicant of that site and facility on the proposed site for the term of the initial permit.

(iii) Other evidence satisfactory to the Department that shows the applicant has the authority to use the proposed site and facility as a site and facility for the term of the permit.

(4) Evidence that the applicant is or will be in compliance with the municipality's zoning requirements.

(5) The following apply to the proposed facility:
(i) If the facility is in existence at the time the initial permit application is submitted to the Department, the applicant shall submit plans and specifications drawn to scale for the interior of the facility.

(ii) If the facility is in existence at the time the initial permit application is submitted to the Department, and the applicant intends to make alterations to the facility, the applicant shall submit renovation plans and specifications for the interior and exterior of the facility to be altered.

(iii) If the facility is not in existence at the time the initial permit application is submitted to the Department, the applicant shall submit a plot plan that shows the proposed location of the facility and an architect's drawing of the facility, including a detailed drawing, to scale, of the interior of the facility.

(6) The name, residential address, date of birth, title and short version of a curriculum vitae of each principal, operator, financial backer and employee of the applicant, or of any person holding an interest in the applicant's proposed site or facility, including:
(i) A verification of identity that is satisfactory to the Department.

(ii) A copy of a criminal history records check for each individual performed in accordance with § 1141a.31 (relating to background checks). This subparagraph does not apply to an applicant who is an owner of securities in a publicly traded corporation or an owner of 5% or less in a privately held business entity and who does not have voting rights to elect or appoint one or more members of the board of directors or other governing board.

(iii) An affidavit from each principal, operator or financial backer of the applicant setting forth the following:
(A) Any position of management or ownership held during the 10 years preceding the filing date of the initial permit application of a controlling interest in any other business in this Commonwealth or any other jurisdiction involving the manufacturing or distribution of medical marijuana, medical marijuana products or a controlled substance.

(B) Whether the principal, operator or financial backer has been convicted of a felony criminal offense related to the manufacture, delivery or possession with intent to manufacture or deliver a controlled substance in violation of The Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. §§ 780-101-780-144), or similar law in any other jurisdiction and, if yes, whether 10 or more years have passed since entry of a final disposition on the conviction or 1 or more years have passed since the individual's release from incarceration for the conviction, whichever is later.

(C) Whether the principal, operator or financial backer has been a party in any civil or administrative action under the laws of the Commonwealth or any other state, the United States or a military, territorial or tribal authority relating to the principal, operator or financial backer's profession, occupation or fraudulent practices, including fraudulent billing practices.

(D) Whether the principal, operator or financial backer has attempted to obtain a registration, license, permit or other authorization to operate a medical marijuana organization in any jurisdiction by fraud, misrepresentation or the submission of false information.

(7) If a principal, operator or financial backer is a corporation or limited liability company:
(i) The names, residential addresses, titles and short version of a curricula vitae of each principal of the corporation or limited liability company.

(ii) A certified copy of the filed articles of incorporation of the corporation or filed certificate of organization of the limited liability company.

(iii) Unless the corporation or limited liability company is a publicly traded company, the names and mailing addresses of all persons owning securities in the corporation or membership interests in the limited liability company.

(8) If a principal, operator or financial backer is a general partnership, limited partnership, limited liability partnership or limited liability limited partnership:
(i) The names, residential addresses, titles and short version of a curricula vitae of each partner and general partner of a general partnership, limited partnership, limited liability partnership or limited liability limited partnership, and if any of the partners is a corporation or a limited liability company, the names, residential addresses, titles and short version of a curricula vitae of each principal of that corporation or limited liability company.

(ii) A certified copy of its filed certificate of limited partnership or other formation document, if applicable.

(iii) A certified copy of its partnership agreement.

(iv) Unless the entity is a publicly traded company, the names and mailing addresses of each of its partners.

(9) Evidence that the applicant is responsible and capable of successfully establishing and operating a facility, including the following:
(i) Demonstrated experience, if any, running a for-profit or nonprofit organization or other business within this Commonwealth or any other jurisdiction and the nature of the business conducted by the organization.

(ii) History relating to a similar license, permit or other authorization in other jurisdictions, including provisional licenses, suspensions, revocations or disciplinary actions, including civil monetary penalties or warnings.

(iii) History of response to sanctions, disciplinary actions or civil monetary penalties imposed relating to any similar license, permit or other authorization in another jurisdiction, and the plans of correction or other responses made to those actions.

(iv) Evidence that the applicant and its principals and other persons affiliated with the applicant identified by the Department is in compliance with all the laws of the Commonwealth regarding the payment of State taxes as shown on the tax clearance certificates issued by the Department of Revenue and the Department of Labor and Industry under § 1141a.27.

(v) A statement that the applicant shall provide evidence of workers' compensation insurance if the applicant is issued a permit and the facility is determined to be operational by the Department.

(10) A description of the duties, responsibilities and roles of each principal, operator, financial backer and employee.

(11) A timetable outlining the steps the applicant will take to become operational.

(12) A summary of the intended plan of operation that describes how the applicant's proposed business operations will comply with the act and this part relating to:
(i) Security.

(ii) Employee qualifications and training.

(iii) Transportation of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products.

(iv) Storage of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products.

(v) With respect to an application for a grower/ processor permit, packaging and labeling of medical marijuana products.

(vi) Inventory management.

(vii) With respect to a grower/processor's facility, nutrient and additive practice.

(viii) With respect to a grower/processor's facility, quality control and testing of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products for potential contamination.

(ix) With respect to a grower/processor's facility, processing and extraction.

(x) Sanitation and safety.

(xi) Recordkeeping.

(xii) Preventing unlawful diversion of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products.

(xiii) With respect to a grower/processor's facility, growing of medical marijuana, including a detailed summary of policies and procedures for its growth.

(xiv) Establishment, implementation and monitoring of diversity goals under § 1141a.32 (relating to diversity goals).

(13) The relevant financial information in § 1141a.30 (relating to capital requirements).

(14) Statements that:
(i) The applicant possesses the ability to obtain in an expeditious manner the right to use the proposed site and facility, including equipment, to properly perform the activity described in the initial permit application.

(ii) The grower/processor permit applicant is able to continuously maintain effective security, surveillance and accounting control measures to prevent diversion, abuse and other illegal conduct regarding seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana and medical marijuana products. The dispensary permit applicant is able to continuously maintain effective security, surveillance and accounting control measures to prevent diversion, abuse and other illegal conduct regarding medical marijuana products.

(iii) The applicant is able to continuously comply with all applicable laws of the Commonwealth, the act, this part, and the terms and conditions of the initial permit.

(15) The applicant shall provide the Department with releases sufficient to obtain information from a governmental agency, financial institutions, an employer or any other person. Failure to provide these releases will result in the rejection of the initial permit application.

(16) A diversity plan demonstrating ability to meet the diversity goals outlined in section 615 of the act (35 P.S. § 10231.615).

(17) A statement summarizing how the applicant intends to positively impact the community where operations are proposed to be located.

(c) If the Department determines that an initial permit application is complete but lacking sufficient information upon which to make a determination, the Department may notify the applicant in writing of the factors that require additional information and documentation. An applicant has 30 days from the mailing date of the notice to provide the requested information and documentation to the Department. An applicant's failure to provide the requested information to the Department by the deadline may be grounds for denial of the issuance of a permit. Nothing in this subsection requires the Department to request additional or supplemental information from an applicant.

(d) At the discretion of the Department, the Department may extend the deadline in subsection (c) for up to an additional 15 days.

(e) The Department may conduct an inspection to determine the appropriateness of a proposed site and facility, the applicant's operational status, the applicant's compliance with the laws and regulations of the Commonwealth, the municipality's zoning requirements relating to the applicant's proposed site and facility, if applicable, and its use as outlined in the permit application. The Department may do the following:

(1) Interview principals, operators, financial backers and employees, including physicians, pharmacists, physician assistants and certified registered nurse practitioners, engaged and to be engaged in the applicant's operations for the purpose of verifying the information contained in the initial permit application.

(2) Inspect transport vehicles that are or will be utilized in the transportation of seeds, immature medical marijuana plants, medical marijuana plants, medical marijuana or medical marijuana products to a facility or an approved laboratory.

This section cited in 28 Pa. Code § 1141a.22 (relating to records subject to disclosure; confidentiality); 28 Pa. Code § 1141a.28 (relating to fees); 28 Pa. Code § 1141a.31 (relating to background checks); 28 Pa. Code § 1141a.39 (relating to change in ownership of a medical marijuana organization); 28 Pa. Code § 1141a.40 (relating to application for approval of a change in location of an operational facility); and 28 Pa. Code § 1161a.40 (relating to additional dispensary locations).

Disclaimer: These regulations may not be the most recent version. Pennsylvania may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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