EMA Jan 2016
Posted: Mon Jul 27, 2020 11:57 pm
From the EMA when OD was granted for MF:
"Designated orphan medicinal products are products that are still under investigation and are considered for orphan designation on the basis of potential activity. An orphan designation is not a marketing authorisation. As a consequence, demonstration of quality, safety and efficacy is necessary before a product can be granted a marketing authorisation."
Quality--yes
Safety--yes
Efficacy--yes
"Designated orphan medicinal products are products that are still under investigation and are considered for orphan designation on the basis of potential activity. An orphan designation is not a marketing authorisation. As a consequence, demonstration of quality, safety and efficacy is necessary before a product can be granted a marketing authorisation."
Quality--yes
Safety--yes
Efficacy--yes