EMA Jan 2016

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biopearl123
Posts: 409
Joined: Fri Jul 20, 2018 5:13 pm

EMA Jan 2016

Post by biopearl123 » 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

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