Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]
EMA published a guideline on the handling and shipping of investigational medicinal products (IMPs) in accordance with GCPs and GMPs. The guideline lays down the principles for the two-step release and shipping of IMPs by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contrac- tual agreements.
[/membership]