National
- Valid in
- Decided by
- Typical for
- Duration
Legal basis
Directive 2001/83/EC (Art. 6, 8)
Marketing authorisation procedures in the EU
Four routes lead to a marketing authorisation in Europe.
View
Which procedure fits?
Best fit:
MRP
- Valid in
- Decided by
- Typical for
- Duration
Legal basis
Directive 2001/83/EC (Art. 28(2), 29)
Process
Good to know
DCP
- Valid in
- Decided by
- Typical for
- Duration
Legal basis
Directive 2001/83/EC (Art. 28(3), 29)
Process
Good to know
Centralised
- Valid in
- Decided by
- Typical for
- Duration
Legal basis
Regulation (EC) No 726/2004 (Art. 3, 6, 10, Annex)