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?

Dear Tina, as you might be aware the normalily 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 will be perfectly acceptable.
Kind regards
Monica Gomar Mengod
Orphan Medicines