ODD....DESIGNATED!! here we go!, page-20

Orphan incentivesProtocol assistance. The Agency provides a form of scientific advice specifically for orphan medicines called protocol... Access to the centralised authorisation procedure. All designated orphan medicines are assessed for marketing... Ten years of market exclusivity. Authorised orphan medicines benefit from ten years of protection from market... Fee reductions. Companies applying for designated orphan medicines pay reduced fees for regulatory activities. This... Grants. E-Rare, a transnational projec...