We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier. Our staff has experience from originator companies as well as from the generic industry and medicinal authorities. For details please see the Billev Pharma team.
There are different ways of licensing medicinal products in EU:
- National procedure followed by the Mutual Recognition procedure (MRP) if a marketing authorisation is desired in more than one member state.
- Decentral procedure (DCP) if a marketing authorisation is desired in more than one member state.
- Central procedure (CP) if a marketing authorisation is desired in all member states.
Which procedure to use depends on the strategy – we can help in this process by giving details on each procedure and outlining the differences.