-
RE: Harmonize submissions of orphan designation annual reports
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 -
RE: Submitting annual report in orphan designation
Since the implementation of the IRIS online portal for all submission related to orphan procedures, joint submissions to EMA/FDA are no longer possible, including for annual reports.
Annual reports for orphan medicinal products designated by the EU should be submitted via the IRIS online portal and within 2 months following the anniversary of the grant of the designation or at World Rare Disease Day (last day of February).
https://www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation/submitting-annual-reports-medicine-development
-
RE: Orphan designation Annual reporting
Thank you for your question.
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).
Monica Gomar Mengod
Orphan Medicines Office