Posted Mon, 10 May 2021 11:52:51 GMT by Sam Bryant Mr
I am drafting a submission for transfer of Orphan Drug Designation to a new sponsor who has acquired all rights to this product. The current sponsor organisation is no longer active, and does not have any contacts that can be entered into the "Current Sponsor Details" of the form.

How could this be resolved?

Thanks.
Posted Tue, 11 May 2021 08:12:59 GMT by Monica Gomar Mengod x
Unfortunately only the current sponsor of an orphan medicinal product designation can trigger a transfer of sponsorship.  As it appears that the current sponsor did not inform EMA and EC before it ceased to exist, there is no other option than for the new sponsor to apply for the orphan designation again. Please kindly let us know the orphan designation you are referring to, for us to put a note for the record and inform the EC. 
 

You must be signed in to post in this forum.