We have assisted with the National procedure from the very beginning of our history in 1978.

Now this procedure has been mostly replaced by European procedures. The National procedure is however still a relevant option if a marketing authorisation is desired in only one European member state.

The National procedure is also the starting point for the Mutual Recognition procedure (MRP). It should be pointed out that due to lack of resources at the different European health agencies a national application followed by MRP can be a slightly longer exercise than the Decentral procedure (DCP).