Is the submission date for the YBPR flexible?
Yes, the date of first submission of the YBPR may be negotiated with BGTD so that it coincides with the submission of a similar report to another regulatory authority. The sponsor should inform BGTD when the first YBPR will be submitted, after which subsequent reports should be submitted every 12 months. Alternatively, the YBPR can be submitted as an addendum to the Annual Drug Notification Report no later than October of each year. Sponsors should begin submitting YBPRs as of June 1, 2006.
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