Or. Admin. Code § 836-200-0545

Current through Register Vol. 63, No. 11, November 1, 2024

Section 836-200-0545 - Public Disclosure of Prescription Drug Manufacturer Filings

(1) As soon as practicable after receiving a filing from a prescription drug manufacturer under OAR 836-200-0530, the department shall post to it's website the name of the manufacturer and the prescription drug that is the subject of the filing.

(2) No later than the applicable date as specified in subsection (3) following the receipt of a filing from a manufacturer under OAR 836-200-0530 or a response to a request for additional information from a manufacturer under OAR 836-200-0535, the department shall post to it's website the information provided by the prescription drug manufacturer in the filing or response.

(3) Each year, the department shall post the information specified in subsection (2) no later than:

(a) March 31, for filings or responses to requests for additional information received between October 1 and December 31 of the previous calendar year;

(b) June 30, for filings or responses to requests for additional information received between January 1 and March 31;

(c) September 30, for filings or responses to requests for additional information received between April 1 and June 30; and

(d) December 31, for filings or responses to requests for additional information received between July 1 and September 30.

(4) As soon as practicable after submission of a request for additional information by the department under OAR 836-200-0535, receipt of a manufacturer's request for additional time to complete a response under 836-200-0535, or submission or receipt of any other correspondence pertaining to the filing from the department or the manufacturer, the department shall post these documents to its website.

(5) Notwithstanding subsections (1) to (4), if a manufacturer has made a trade secret claim, the information that is the subject of the trade secret claim will not be posted to the department's website until a determination has been made by the department or, in the case of a manufacturer's appeal, the director, as specified by OAR 836-200-0540.

(6) No information determined by the department to be exempt from disclosure under OAR 836-200-0540 shall be included in the information posted to the department's website.

Or. Admin. Code § 836-200-0545

ID 2-2019, adopt filed 02/26/2019, effective 3/1/2019; ID 1-2020, amend filed 01/29/2020, effective 2/1/2020

Statutory/Other Authority: Or Laws 2018, ch 7

Statutes/Other Implemented: Or Laws 2018, ch 7