Orphan designation Annual reporting

Dear all

Our client received an OMPD designation and therefore should submit an annual report in the following years. When are the annual reports due? is it similar to FDA, in which it should be submitted one year+ up to 60 days after the date of the designation? for example, if the designation was accepted on 24 April 2019, should the annual report be submitted no later than 24 June 2020.

Thank you!
Liron

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

Thank you very Much!

On a related matter, is there a list or a demo for the filling of annual report fields in IRIS? 
This way we would know which fields need to be filled out and to what extent, and can prepare the content ahead of submission 

Best regards,
Liron

Mandatory fields are highlighted with a red asterisk to the right of the field. That said, applicants are encouraged to fill in all the fields in the form.