Or. Admin. Code § 836-200-0525
Current through Register Vol. 63, No. 11, November 1, 2024
Section 836-200-0525 - Expectations of Reporting Manufacturers(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.Or. Admin. Code § 836-200-0525
ID 2-2019, adopt filed 02/26/2019, effective 3/1/2019Statutory/Other Authority: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch 7