Or. Admin. Code § 836-200-0525 - Expectations of Reporting Manufacturers
(1) Reporting
manufacturers must act in good faith to include all of the information required
in a report or a response to a request for additional information under OAR
836-200-0530 to
836-200-0535, and conduct a
reasonable investigation to ensure the accuracy and completeness of their
reports.
(2) If any of the
information required in a report or a response to a request for additional
information under OAR
836-200-0530 to
836-200-0535 is not available to
the reporting manufacturer at the time of the filing due to circumstances
outside the manufacturer's control, the manufacturer must provide any available
portion of the required information and a thorough explanation. The explanation
must include a description of the missing information and the circumstances
contributing to the manufacturer's inability to meet the requirement.
(3) If the information required in a report
or a response to a request for additional information under OAR
836-200-0530 to
836-200-0535 is not currently
available to the manufacturer but is expected to be available in the future,
the manufacturer must provide an explanation and a timeline for providing the
required information to the department.
(4) When providing information required by
ORS 646A.689(2) to
(7), reporting manufacturers must act in good
faith to limit information provided to the department to information that is
necessary for the director's review and analysis of drug prices.
(5) A reporting manufacturer's failure to
comply with sections (1) to (4) of this rule may subject the manufacturer to a
civil penalty under OAR
836-200-0560.
Notes
Statutory/Other Authority: ORS 646A.689
Statutes/Other Implemented: ORS 646A.689 & 646A.692
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(1) Reporting manufacturers must make a good-faith effort to include all of the information required in a report or a response to a request for additional information under OAR 836-200-0530 and 836-200-0535,and conduct a reasonable investigation to ensure the accuracy and completeness of their reports.
(2) If any of the information required in a report or a response to a request for additional information under OAR 836-200-0530 and 836-200-0535 is not available to the reporting manufacturer at the time of the filing due to circumstances outside the manufacturer's control, the manufacturer must provide any available portion of the required information and a thorough explanation. The explanation must include a description of the missing information and the circumstances contributing to the manufacturer's inability to meet the requirement.
(3) If the information required in a report or a response to a request for additional information under OAR 836-200-0530 and 836-200-0535 is not currently available to the manufacturer but is expected to be available in the future, the manufacturer must provide an explanation and a timeline for providing the required information to the department .
(4) Reporting manufacturers must make a good-faith effort to limit information provided to the department to information that is necessary for the director's review and analysis of drug prices under 2018 Or Laws ch 7.
(5) A reporting manufacturer 's failure to comply with the expectations specified in (1)-(4) of this section may subject the manufacturer to a civil penalty under OAR 836-200-0560.
Notes
Statutory/Other Authority: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch 7