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§ 10231.2003. Research study

Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: June 22, 2018

Purdon's Pennsylvania Statutes and Consolidated Statutes
Title 35 P.S. Health and Safety (Refs & Annos)
Chapter 64. Medical Marijuana Act (Refs & Annos)
Chapter 20. Academic Clinical Research Centers and Clinical Registrants (Refs & Annos)
Effective: June 22, 2018
35 P.S. § 10231.2003
§ 10231.2003. Research study
(a) Applicability.--The provisions of this section shall apply upon publication of the notice under section 2108.1
(b) Procedures.--The department may, upon application, approve the dispensing of medical marijuana by a clinical registrant to the academic clinical research center for the purpose of conducting a research study. The department shall develop the application and standards for approval of such dispensing by the clinical registrant. The following apply to the research study:
(1) The clinical registrant shall disclose the following information to the department in its application:
(i) The reason for the research project, including the reason for the trial.
(ii) The strain and strength of medical marijuana to be used in the research study.
(iii) The anticipated duration of the study.
(iv) Evidence of approval of the trial by an accredited institutional review board and any other required regulatory approvals.
(v) Other information required by the department, except that the department may not require disclosure of any information that would infringe upon the academic clinical research center's exclusive right to intellectual property or legal obligations for patient confidentiality.
(2) The academic clinical research center shall provide its findings to the department within 365 days of the conclusion of the research study or within 365 days of publication of the results of the research study in a peer-reviewed medical journal, whichever is later.
(3) The department shall allow the exchange of medical marijuana seed between clinical registrants for the conduct of research.

Credits

2016, April 17, P.L. 84, No. 16, § 2003, effective in 30 days [May 17, 2016]. Amended 2018, June 22, P.L. 322, No. 43, § 5, imd. effective.

Footnotes

35 P.S. § 10231.2108.
35 P.S. § 10231.2003, PA ST 35 P.S. § 10231.2003
Current through Act 10 of the 2024 Regular Session. Some statute sections may be more current, see credits for details.
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