Submitting annual report in orphan designation

Dear All
 

We have to submit the annual report in orphan designation in the IRIS system. Previous it was done by sending the annual report in a mail to EMA. I have chosen “annual report” and “Submission notes” in submission Form, but the generated application form only has three fields: Submission details, phone no and email. It is not the same form as we have completed previously. Have I chosen the right path/form?

Thanks in advance
Dorte Dyregaard

Yes. The "submission form" is just a copy of some of the data provided to EMA. The previous PDF form is not necessary anymore. 

Thank you .
We also have orphan drug designation within FDA (same indication) and as I can understand we should only submit one annual report ( EMA/121846/2010)  - Should I write it in the report or tick of a field somewhere that the report is for both the US and the EU?

Thanks
Dorte Dyregaard

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