Human medicines - Orphan medicinal products
Orphan designation - Transfer of orphan designation
The documents below set out the requirements for the transfer of an orphan designation to another sponsor, as well as the requirements in the event that there is a change in the existing sponsor's name or address.
abrir aquí para acceder al documento EMEA completo:
European Medicines Agency - Human Medicines - Orphan medicinal products - Orphan designation - Transfer of orphan designation
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