Current through Register Vol. 54, No. 44, November 2, 2024
(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):
(1) A research contract.
(2) A description of a research program or
research study.
(3) An ACRC's
intellectual property.
(4) An
approved clinical registrant's intellectual property.
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).
