Harmonize submissions of orphan designation annual reports

Dear all,

Is it possible to submit an annual report earlier than 1 year after the anniversary in order to harmonize the submission dates of reports for ODDs in other indications?

As you might be aware the rule is that annual reports for orphan medicinal products designated by the EU should be submitted within 2 months following the anniversary of the grant of the designation or at World Rare Disease Day (last day of February). Nevertheless, your proposal is acceptable.
 

Would it also be acceptable to submit an EU ODD Annual Report earlier, in order to harmonize the submission dates for EU and FDA Annual reports?

We certainly welcome submission of annual reports of orphan medicinal products designations in parallel if it helps to streamline the process at your end. 

Do we still receive notifications/reminders that the Annual Report is expected? Or are Sponsors to manage and submit without request from the Agency?

The IRIS system does not send notifications or reminders to solicit annual reports on orphan designations. According to Art. 5.10 of the Orphan Regulation, it is the responsibility of the Sponsor to provide an annual report on the state of the development of the designated product. More information can be found in the specific page on the EMA website: Submitting annual reports on medicine development.