reference medicinal product - TOPRA
reference medicinal product - TOPRA
reference medicinal product - TOPRA
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Which procedure should I use?<br />
National<br />
•“Test the water” – opinion of a single<br />
MS<br />
•Only one market of interest<br />
•Non-EU countries<br />
DCP = Procedure of choice<br />
•Joint assessment / decision by RMS<br />
and CMSs<br />
•Choice of CMSs: 1 to 29<br />
•Clock stop available<br />
MRP<br />
•“Test the water with national”<br />
•If already have MA from a pre-2005<br />
application<br />
•Repeat Use<br />
• Portfolio expansion<br />
• Add 10-yr countries<br />
•Selected MSs: 1 to 29<br />
•No clockstop<br />
Centralised<br />
•Assessment by rapporteur and corapporteur<br />
•Clockstop available<br />
•All EEA in one application – no<br />
flexibility<br />
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