Current through Register Vol. 54, No. 45, November 9, 2024
Section 1211a.27 - Application for approval of a clinical registrant(a) An applicant shall file an application for approval of a clinical registrant with the Department on a form prescribed by the Department. The Department will publish a notice in the Pennsylvania Bulletin announcing the availability of applications and the time period during which the Department will accept applications.(b) An application for approval of a clinical registrant submitted under this section must include all of the following information:(1) The legal name, address and telephone number of the applicant and the name, telephone number and professional e-mail address of an individual who will be the primary contact for the Department during the Department's review of the application.(2) The name of the ACRC under § 1211a.25 (relating to certifying ACRCs).(3) The applicant's Federal and State tax identification numbers.(4) An affidavit, on a form prescribed by the Department, disclosing any payments made by the applicant, a principal or financial backer of the applicant to an ACRC or any affiliates of an ACRC, up to and including the date of the submission of the application. The affidavit must include the amount and purpose of each payment made.(5) The name of an institution of higher education, if any, that will be participating in an approved research program or research study.(6) An affidavit and release under § 1211a.24 (relating to capital requirements).(7) Evidence that the applicant is responsible and capable of successfully operating as an approved clinical registrant, including all of the following: (i) A copy of the research contract between the applicant and the ACRC.(ii) A description of the research program or research study the applicant and the ACRC intend to conduct.(iii) A statement that the applicant may not engage in the business of selling, dispensing or offering to dispense medical marijuana products at an applicant's dispensary as a clinical registrant until the clinical registrant's grower/processor and dispensary facilities have been inspected and deemed operational by the Department.(8) Except as provided in § 1211a.28 (relating to request for conversion of an existing permit), an application for a grower/processor permit under Chapters 1141a and 1151a (relating to general provisions; and growers/ processors).(9) Except as provided in § 1211a.28, an application for a dispensary permit under Chapter 1141a and Chapter 1161a (relating to dispensaries).(10) A statement that a false statement made by the applicant is punishable under the applicable provisions of 18 Pa.C.S. Chapter 49 (relating to falsification and intimidation).(c) An applicant may only include one ACRC in its application for approval of a clinical registrant.(d) The following documents provided to the Department under this chapter are confidential and not subject to disclosure under the Right-to-Know Law (65 P.S. §§ 67.101-67.3104): (2) A description of a research program or research study.(3) An ACRC's intellectual property.(4) An approved clinical registrant's intellectual property.Adopted by Pennsylvania Bulletin, Vol 53, No. 09. March 4, 2023, effective 3/4/2023 This section cited in 28 Pa. Code § 1211a.24 (relating to capital requirements); 28 Pa. Code § 1211a.28 (relating to request for conversion of an existing permit); 28 Pa. Code § 1211a.30 (relating to approval or denial of an application for approval of a clinical registrant); and 28 Pa. Code § 1211a.32 (relating to revocation of approval of a clinical registrant).