Or. Admin. Code § 333-333-4000
Current through Register Vol. 63, No. 12, December 1, 2024
Section 333-333-4000 - [Effective until 1/1/2025] Application Process(1) Applications must be submitted to the Oregon Health Authority (Authority) in the form and manner prescribed by the Authority.(2) The application fee specified in OAR 333-333-4060(1) must be submitted at the time of application in the form and manner prescribed by the Authority.(3) An application must include the following: (a) The names and required information for all individuals and legal entities who are applicants as required by OAR 333-333-4030.(b) Any forms and information required by the Authority to evaluate the license application.(c) A social equity plan as required by OAR 333-333-4020.(d) Until January 1, 2025, proof of residency if required by OAR 333-333-4050.(e) For manufacturer, service center and laboratory license applicants, a map and diagram of the proposed license premises, including the boundaries of the licensed premises relative to its location, identification of any unlicensed areas within the building where the licensed premises is located including suite numbers if applicable, identification of any residence or other unlicensed structures located on the same tax lot as the premises proposed to be licensed, a scaled floor plan identifying all points of ingress and egress, camera locations, limited access areas, client administration areas and areas where psilocybin products will be stored within the licensed premises as required by OAR 333-333-4510. The Authority may request additional documents or information related to the proposed licensed premises, including but not limited to photographs of the premises.(f) If the applicant for a manufacturer license is not the owner of the real property proposed to be licensed, a written statement signed by the property owner that shows that the owner consents to manufacturing of psilocybin products on the property. This requirement must be satisfied by using the designated form published by the Authority on its website.(g) For service center applicants, a service center emergency plan as described in OAR 333-333-4460.(h) For service center applicants whose proposed licensed premises includes outdoor administration areas, a detailed description of the outdoor administration areas including their location and verification that the area is free from hazards as required by OAR 333-333-5210.(i) For service center and manufacturer applicants, a statement that every individual person and legal entity who holds a financial interest in the entity proposed to be licensed complies with the requirements of ORS 475A.280.(j) For facilitator applicants, documentation that the applicant has completed training at a training program with curriculum that has been approved by the Authority and that meets the requirements of OAR 333-333-3005 to OAR 333-333-3090.(k) For facilitator applicants, documentation that the applicant has passed the exam required by ORS 475A.325.(l) For laboratory applicants, documentation that the applicant has received accreditation as described in ORS 475A.606.(4) In addition to submitting an application form and the items described in section (3) of this rule, the Authority may require:(a) Information or fingerprints required to perform a criminal background check in accordance with OAR 333-333-4100.(b) Any additional information that is reasonably required to determine the merits of the license application.(5) The Authority must review an application to determine if it is complete. An application may be considered incomplete if the form is not complete, the application or license fee has not been paid, or additional information or documentation required under this rule has not been submitted, included but not limited to:(a) Documentation that an applicant for a facilitator license has completed the training required by ORS 475A.325.(b) Documentation that an applicant for a facilitator license has passed the exam required by ORS 475A.325.(c) Results of required criminal background checks completed pursuant to OAR 333-333-4100.(d) A land use compatibility statement from the city or county that authorizes land use in the city or county where the premises of a manufacturer or service center proposed to be licensed is located.(e) Other required forms and documents identified in the training, licensing and compliance system.(6) The Authority will notify an applicant in writing if their application is determined to be incomplete. The applicant will have 90 days from the date the notice is issued to submit a complete application. If the applicant does not complete their application within 90 days, the Authority will close the application. If the Authority closes an application, the applicant may submit a new application, including a non-refundable application fee, at any time.(7) An applicant may submit a written request for reconsideration of an application that is closed as incomplete. Such a request must be received by the Authority within 10 calendar days of the date the closure notice was mailed to the applicant. The Authority will notify the applicant of the results of their request following receipt of the request for reconsideration.Or. Admin. Code § 333-333-4000
PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024Statutory/Other Authority: ORS 475A.235, ORS 475A.245 & ORS 475A.255
Statutes/Other Implemented: ORS 475A.235, ORS 475A.245, ORS 475A.255 & ORS 475A.594